AYUSH

AYU Access this article online
Website: www.ayujournal.org
DOI: 10.4103/0974-8520.169010
Review Article Quick Response Code:
Role of AYUSH workforce, therapeutics, and principles in

health care delivery with special reference to National Rural
Health Mission
Janmejaya Samal
Public Health Researcher, Pune, Maharashtra, India
Abstract
Decades back AYUSH systems of medicine were limited to their own field with few exceptions
in some states as health in India is a state issue. This took a reverse turn after the initiation of
National Rural Health Mission (NRHM) in 2005 which brought the concept of “Mainstreaming
of AYUSH and Revitalization of Local Health Traditions” utilizing the untapped AYUSH
workforces, therapeutics and principles for the management of community health problems.
As on 31/03/2012 AYUSH facilities were co-located in 468 District Hospitals, 2483 Community
Health Centers and 8520 Primary Health Centers in the country. Several therapeutics are
currently in use and few drugs have been included in the ASHA drug kit to treat common
ailments in the community. At the same time Government of India has recognized few principles
and therapeutics of Ayurveda as modalities of intervention to some of the community health
problems. These include Ksharasutra (medicine coated thread) therapy for ano-rectal surgeries
and Rasayana Chikitsa (rejuvenative therapy) for senile degenerative disorders etc. Similarly
respective principles and therapeutics can also be utilized from other systems of AYUSH such
as Yoga and Naturopathy, Unani, Siddha and Homoeopathy. Akin to Ayurveda these principles
and therapeutics can also help in managing community health problems if appropriately
implemented. This paper is a review on the role of AYUSH, as a system, in the delivery of
health care in India with special reference to National Rural Health Mission.
Key words: AYUSH, National Rural Health Mission, principles, therapeutics, workforce
Introduction limited to their own field with few exceptions in some states,
as health in India is a state issue. This took a reverse turn after
AYUSH is an acronym for Ayurveda, Yoga and Naturopathy, the initiation of NRHM and the AYUSH systems were brought
Unani, Siddha and Homeopathy and are the six Indian systems into the mainstream health care. NRHM came into play in 2005
of medicine prevalent and practiced in India and some of the but implemented at ground level in 2006 and introduced the
neighboring Asian countries with very few exceptions in some of concept of “mainstreaming of AYUSH and revitalization of local
the developed countries. A department called the department health traditions” to strengthen public health services.[4,5] This
of Indian system of medicine was created in March 1995[1,2] and concept helped in utilizing the untapped AYUSH workforce,
renamed to AYUSH in November 2003[3] with a focus to provide therapeutics and the principles for the management of
community health problems at different levels. This convergence
increased attention for the development of these systems. This
has been envisaged with the following objectives:
was felt in order to give increased attention to these systems in
the presence of a strong counterpart in the form of allopathic
system of medicine which lead to an “architectural correction”
in the health service envisaged by National Rural Health This is an open access article distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
Mission (NRHM). Before the initiation of NRHM most of these others to remix, tweak, and build upon the work non‑commercially, as long as the
systems including workforces, therapeutics and principles were author is credited and the new creations are licensed under the identical terms.
For reprints contact: reprints@medknow.com

Address for correspondence: Dr. Janmejaya Samal,
A/8, Gulmohar Colony, Behind PCMC Garden,
How to cite this article: Samal J. Role of AYUSH workforce, therapeutics,
Pimple Gurav, Pune - 411 061, Maharashtra, India. and principles in health care delivery with special reference to National Rural
E‑mail: janmejaya_samal@yahoo.com, Health Mission. Ayu 2015;36:5-9.
© 2015 AYU (An International Quarterly Journal of Research in Ayurveda) | 5

Official publication of Institute For Post Graduate Teaching & Research in Ayurveda,Jamnagar | Published by Wolters Kluwer - Medknow
Samal: Role of AYUSH system in health care delivery
• Choice of the treatment system to the patients number of AYUSH paramedical staffs have been appointed.
• Strengthen facility functionally AYUSH paramedical staffs have not been appointed in many
• Strengthen implementation of national health programs.[3‑5] states like Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Delhi,
Gujarat, Jharkhand, Meghalaya, Mizoram, Nagaland, Orissa, Uttar
In the mainstreaming of AYUSH and revitalization of local
Pradesh, Dadra‑Nagar Haveli and Diu‑Daman [Figures 1 and 2].[1]
health traditions AYUSH workforce, therapeutics and principles
Similarly about 17.7 lakhs of rural population were being served
have been implemented in various states at a different level.
by each DHs, 3.3 lakhs of the rural population were being
Objective served by each CHCs and 1.0 lakhs of the rural population were
The main objective of this study was to assess the role being served by each PHCs in various states/UTs wherever the
and contributions of AYUSH systems including workforce, corresponding facilities existed [Tables 1 and 2].[1] The required
therapeutics and principles in health care delivery with special number of AYUSH workforces has been articulated in the Indian
reference to NRHM. Public Health Standards (IPHS) documents [Table 3].[6‑9] The role
and responsibilities of AYUSH doctors have been spelt out very
carefully in their term of reference (TOR). As per the TOR, an
Methodology AYUSH doctor should support in the implementation of national
health programs after requisite training if required. Training and
A review based study. Information pertaining to this study was orientation of AYUSH doctor is one of the important agenda of
primarily obtained from various governmental documents in the NRHM. There are some job responsibilities mentioned under
concerned domain. the TOR which are beyond the scope of an AYUSH doctor as
per his/her educational training and exposure. Let us pick up
Discussion some responsibilities mentioned in the TOR of AYUSH doctors
in Orissa; conducting minor surgery, abscess surgery, conducting
This section delineates the role of AYUSH workforce, therapeutics normal delivery and insertion of intrauterine contraceptive devices
and principles. As the paper focuses on the role of AYUSH are beyond the scope of an AYUSH doctor as per their training
system with special reference to NRHM, hence a discussion and exposure. Similarly planning and implementation of national
on mainstreaming of AYUSH and revitalization of local health disease control program, national health programs such as
traditions is very much imperative. The concept of mainstreaming immunization program, Reproductive and Child Health program,
of AYUSH was an idea in the 9th five year plan before it was supervision of Village Health Nutrition Day and Pustikar Divas,
actually implemented in the country by NRHM in 2005.[3] By implementation of Integrated Management of Neonatal and
this AYUSH doctors are co-located in various health facilities Childhood Illnesses requires a lot of training and orientation of
such as Primary Health Center (PHC), Community Health AYUSH doctors.[10]
Center (CHC), sub district hospital, and district hospital (DH). AYUSH principles have also been utilized for the management
AYUSH facilities have been created in 468 DHs, 2483 CHCs and of common community health problems. These are evident
8520 PHCs as on 31/03/2012. About 76.3% DHs, 51.6% CHCs from the program implementation and planning (PIPs) of
and 35.7% PHCs have been co-located with AYUSH facilities by various states. Many of such programs are being run successfully
this time. As on 31/03/2012 there were 1,0439 AYUSH doctors in some states whereas some states have asked for approval of
and 4146 paramedical staffs serving in India. A maximum of 1386 some other programs in their PIPs. List of such activities are as
doctors have been appointed in the state of Bihar, whereas Orissa follows:
and Rajasthan have 1237 and 1013 AYUSH doctors appointed • Information Education and Communication (IEC)/
respectively. Delhi and Jharkhand are the only two states where Behavior Change Communication (BCC) ‑ The PIP of
AYUSH doctors have not been appointed. In case of paramedical
staffs, Andhra Pradesh is the state where a maximum of 1500
Puducherry
Uttarakhand 1%
10%
Tripura Uttarakhand AP Assam
2% 4% 4% Tamilnadu
1%
Tamilnadu 7%
4% UP
7%
Rajasthan Bihar Rajasthan
10% 14% Andhrapradesh
10%
38%
Punjab
Gujrat Punjab
2%
9%
Odisha Haryana 5%
12% 2%
Maharashtra Karnataka
Himchal Pradesh
1% 3% 2%
Maharashtra Madhyapradesh Kerala Karnataka Jammu & Kashmir Madhyapradesh Kerala Jammu & Kashmir Haryana
6% 5% 6% 6% 4% 4% 6% 9% 5%
Figure 1: State wise distribution of AYUSH doctors appointed Figure 2: State wise distribution of AYUSH paramedics appointed
on a contractual basis in primary health centers under National on a contractual basis in primary health centers under National
Rural Health Mission till 31/03/2012 Rural Health Mission till 31/03/2012
6 AYU | Jan-Mar 2015 | Vol 36 | Issue 1

different states/union territories mention that they held school teachers of the importance of Yoga. Rajasthan
various IEC/BCC activities to sensitize the community mentions about “Suposhanam” a community nutrition
regarding the benefit of AYUSH and Local Health program for tribal women and Ayurved mobile units
Traditions services • Outreach activities ‑ Jharkhand, Himachal Pradesh,
• Specialty Clinics/Wards ‑ Ksharasutra clinic for anorectal Jammu‑Kashmir and Orissa mentioned about utilization of
disorders and Panchakarma therapy unit for intensive and AYUSH doctors in mobile medical units. Madhya Pradesh
specialized treatment have been mentioned by half of the and Tripura mentioned an innovative program of AYUSH
sates in their PIP call center in their PIP
• AYUSH health programs ‑ School Yoga program and Yoga • Establishment of AYUSH epidemic cell – Tamil Nadu
camp are some of the AYUSH health programs mentioned and Kerala are using AYUSH services for prevention
by states like Orissa, Punjab and Andhra Pradesh. Tripura and control of epidemics, e.g. use of Homoeopathy
being little ahead mentions about sensitization of primary for controlling Chikungunya outbreak. Rapid action
epidemic cell of homoeopathy is a major AYUSH initiative
highlighted in Kerala PIP
Table 1: Average rural population served per Rural
• Local health traditions ‑ The IPHS prescribes setting up of
Health Infrastructure as on 31.03.2012
a herbal garden in sub center and PHC premise within the
Rural population served under Rural Health available space, which has not been reflected in any of the
Infrastructure co‑located with AYUSH facilities state PIPs. Whereas certain states have mentioned some
Per each DH Per each CHC Per each PHC innovative activities like Chhattisgarh has mentioned
17.7 lakhs 3.3 lakhs 1.0 lakhs about an innovative activity called “Ayurved Gram”, “Dadi
AYUSH: Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homeopathy, DH: District Maa Ki Batua” in Jammu and Kashmir PIP which plans
hospital, CHC: Community Health Center, PHC: Primary Health Center to include home reme`dies in AYUSH drug kit. Madhya
Pradesh has mentioned about “Gyan Ki Potli,” which
Table 2: National level contractual appointments also includes available and use home remedies that are
under AYUSH as on 31.03.2012 accessible and affordable for various ailments. Haryana has
planned courses on local health traditions for unemployed
Number of contractual Percent distribution of youth.[11‑13]
appointments under contractual appointments
AYUSH under AYUSH Several therapeutics have been proposed and many are being
Doctors Paramedical staff Doctors Paramedical staff used for the management of common community health
10439 4146 100.0% 100.0% problems. Some of the drugs have been included in ASHA
AYUSH: Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homeopathy, DH: District kit for the management of health problems at the first hand
hospital, CHC: Community Health Center, PHC: Primary Health Center at village level. One of the Ayurvedic products known as
Table 3: AYUSH workforce as per IPHS guidelines

Centers Personnel
Essential Desirable Essential Desirable Qualification
Sub Center
No workforce has been
suggested
Primary Health Center
Type A (<20 deliveries per month) Type B (>20 deliveries per month)
Medical officer (AYUSH) - 1* - 1* Graduate in AYUSH
Pharmacist (AYUSH) - 1 - 1
Community Health Center
Graduate medical officer 1 - No categorization Graduate in AYUSH
(AYUSH)
Pharmacist (AYUSH) 1 - No categorization
Sub District Hospital
31-50 bedded SDH 51-100 bedded SDH
AYUSH Physician 1# - 1 -
District Hospital≠ 100 beds 200 beds 300 beds 400 beds 500 beds
AYUSH physician& 1 1 1 2 2
AYUSH pharmacist 1 1 1 1 1
*To provide choices to people wherever an AYUSH facility is not available in the near vicinity, #Provided there is no AYUSH hospital/dispensary in the district head quarter.
One from AYUSH Safai Karamchari is to be outsourced, &If more than one AYUSH doctors are available, at least one doctor should have a recognized PG qualification in relevant
system under AYUSH, ≠AYUSH services have proposed in the essential category at district hospital. AYUSH: Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homeopathy,
IPHS: Indian Public Health Standard, SDH: Sub District Hospital
AYU | Jan-Mar 2015 | Vol 36 | Issue 1 7

Table 4: Total number of AYUSH drugs proposed Financial support and sponsorship
Nil.
Name of the Ayurveda Unani Siddha Homoeopathy
institution Conflicts of interest
Sub Center ‑ ‑ ‑ ‑ There are no conflicts of interest.
Primary Health 100 113 37+1* 481
Center References
Community 125 116 93+1* 483
Health Center 1. Department of AYUSH. Available from: http://www.indianmedicine.nic.in.
Sub District ‑ ‑ ‑ ‑ [Last accessed on 2013 Dec 10].
Hospital 2. Department of ISM and H. National Policy on ISM and H‑2002.
District Hospital ‑ ‑ ‑ ‑ New Delhi: Ministry of Health and Family Welfare, Government of India;
2002.
*One patient and proprietary drug named 777 oil for psoriasis has been proposed.
3. National Health System Resource Center‑National Rural Health
AYUSH: Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homeopathy
Mission, Mainstreaming of AYUSH and Revitalization of Local Health
Traditions under NRHM, An Appraisal of the Annual State Programme
Punarnavadi Mandura has been included in the ASHA kit Implementation Plans 2007–2010 and Mapping of Technical Assistance
for the management of anemia at the community level. The Needs. New Delhi: Ministry of Health and Family Welfare, Government
potential of Ayurveda drugs to tackle community health of India; 2011.
4. Ministry of Health and Family Welfare. National Rural Health
problems resulting from nutritional deficiencies, epidemics
Mission (2005–2012), Mission document. New Delhi: Government of
and vector‑borne diseases has been widely recognized.[14] India; 2005.
Government of India has recognized some of the principles and 5. National Rural Health Mission. Framework of Implementation 2005–2012.
therapeutics of Ayurveda as a mode of intervention to some of New Delhi: Ministry of Health and Family Welfare, Government of India;
the community health problems. These include Ksharasutra 2005.
therapy for anorectal disorders, Rasayana Chikitsa (rejuvinative 6. Ministry of Health and Family Welfare, Indian Public Health Standards,
Revised Guidelines for Primary Health Center, Directorate General of
therapy) for senile degenerative disorder, etc. A list of the
Health Services, New Delhi: Govt. of India; 2012.
AYUSH drugs proposed in the IPHSs at different level of health 7. Ministry of Health and Family Welfare, Indian Public Health Standards,
care institutions is placed at Table 4.[14] Revised Guidelines for Community Health Center, Directorate General
of Health Services. New Delhi: Govt. of India; 2012.
Conclusion 8. Ministry of Health and Family Welfare, Indian Public Health Standards,
Revised Guidelines for Sub District Hospital, Directorate General of
Health Services. New Delhi: Govt. of India; 2012.
With an abysmally deficient health infrastructure the role of 9. Ministry of Health and Family Welfare, Indian Public Health Standards,
AYUSH system in delivering health care services in the rural Revised Guidelines for District Hospital, Directorate General of Health
India is palpable. The grossly deficient health workforces in rural Services. New Delhi: Govt. of India; 2012.
India are hugely replenished by AYUSH doctors and paramedics. 10. Govt. of Odisha, National Rural Health Mission. Available from: http://
www.nrhmorissa.gov.in/./REVISED%20ToR%20OF%20AYUSH%20D.
Many of the therapeutics are being used in different forms for
[Last accessed on 2013 Dec 11].
the management of community health problems which are safe 11. National Rural Health Mission, 2007–08: State Programme Implementation
and effective. Many of the principles described in the classical Plans 2007–08, State Specific. New Delhi: Ministry of Health and Family
texts of Ayurveda and other systems of medicine such as Yoga Welfare, Government of India; 2008.
and Naturopathy are being utilized and many of them are 12. National Rural Health Mission, 2008–09: State Programme Implementation
proposed in the state program implementation and planning Plans 2008–09, State Specific. New Delhi: Ministry of Health and Family
(PIP). This scenario is not the same in all the states as health Welfare, Government of India; 2009.
13. National Rural Health Mission, 2009–10: State Programme Implementation
in India is a state issue. This problem has to be sorted out for
Plans 2009–10, State Specific. New Delhi: Ministry of Health and Family
the effective implementation of mainstreaming of AYUSH and Welfare, Government of India; 2010.
revitalization of local health tradition in a more homogenous 14. Samal J. What makes the ayurveda doctors suitable public health
manner throughout the nation. workforce? Int J Med Sci Public Health 2013;2 (4):919‑923.
8 AYU | Jan-Mar 2015 | Vol 36 | Issue 1

Homoeopathy: The Method of Gentle Healing
HOMOEOPATHY
-: THE METHOD OF GENTLE HEALING:-
Content drafted by
Dr. Subhasish Sarkar
Medical Officer (Homoeopathy),
Dept of AYUSH, AIIMS Bhubaneswar
Dr. Asif Sardar

Medical Officer (Homoeopathy),
Dept. of AYUSH, AIIMS Bhubaneswar
1 Dept. of AYUSH, AIIMS Bhubaneswar

INTRODUCTION
Homoeopathy is the popular system of medicine based on the pivot law "Similia Similibus
Curentur" that means similar suffering is treated by similar kind of therapeutic agents.
Homoeopathy was discovered by a German physician, Dr. Christian Fredrick Samuel
Hahnemann in the 18th century.1 The concept ‘Law of Similars' was also observed by
Hippocrates and Paracelsus before Samuel Hahnemann, but Dr. Hahnemann established it
scientifically although he lived in a time when modern laboratory methods were almost
unknown.2
The word HOMOEOPATHY is derived from the Greek word ‘HOMEOS’ means similar &
‘PATHOS’ means suffering. Homoeopathy is the treatment method for treating the sick
person by therapeutic agents that have the power to produce similar symptoms in healthy
human beings and simulate the natural disease, which is capable of bringing cure in the
diseased person.
In homoeopathy we follow the "INDIVIDUALISTIC" & "HOLISTIC" approach that simply

means pain in the right eye; pain on the left side of head or pain in the abdomen is not the
disease, it is the outcome of a diseased body. We think a person as a whole is sick; that's why
those symptoms are produced. So we treat not only the symptoms but also treat the patient as
a whole. Hence in this universe, each person is different as genetic structure and expression
are different, so how could it be possible that the same medicines are given to different
patients for identical sufferings. So, we believe each patient is unique & they need to treat
differently from each other, and that is the individualistic approach.1
Homoeopathic medicines are prepared from different sources like plants, animals, minerals &
other natural substances. With the help of dynamization and potentization, we increase the
inner medicinal power of inert substances and reduce the toxicity and material properties of
the inert substance. Then medicines are proved on healthy human beings to ascertain the
curative power of every particular medicine, which later written down in book form. During
treatment, we use those symptoms for finding a suitable medicine for the diseased person.1
Homoeopathic medicine stimulates the entire defense mechanism of disease persons to

counter the disease conditions in a natural way. It rectifies the diseased person's derangement
by producing artificial disease conditions similar to the existing disease conditions in patient.
2
As the popularity of homoeopathy treatment grows worldwide, it has become inevitable to

establish this science on the basis of scientific evidence. Clinical trials have been published
in indexed journals showing the effectiveness of homoeopathy, along with systematic reviews
and meta‑analysis. Research organizations worldwide are focusing on building the evidence
base for Homoeopathy.3

HOMOEOPATHY IN INDIA
India has a population of over one billion and is an emerging economic global power. The
country shows a wide variation in per capita income and purchasing parity, impacting
income, expenditure, and social stratification. The collective orientation of the society reflects
itself in the National Health Policy of India and also underlines the governmental patronage
to modern as well as the Indian systems of Medicines and Homoeopathy.4
It is more than a century that homoeopathy is being practiced in India. It has been well
established as a significant part of India's health care system and plays an essential role in
providing health care to a large number of people as an alternative medicine. 3
Homoeopathy is considered the second largest system of medicine used in India and the
world. As per the analysis done by the Ministry of AYUSH, the use of homoeopathy is
steadily growing in India and, with an annual growth rate of 26.3% in the past year, the
highest among the other AYUSH modalities. In India, for medical care, Homoeopathy leads
as the second position, and over 100 million people depend on homeopathy for their medical
care.5
GLOBAL SCENARIO OF HOMOEOPATHY
Several surveys suggest many people integrate, use, and value homoeopathy as a
complementary treatment option.3 Worldwide, over 200 million people use homeopathy on a
regular basis. Homoeopathy is currently practiced in over 80 countries. It has legal
recognition as an individual system of medicine in 42 countries and is recognized as a part of
complementary and alternative medicine in 28 countries.6 WHO considers homeopathy, as
one of the most commonly used forms of Traditional & Complementary Medicine7 and
fastest-growing and second-most widely used system of medicine in the world. 5
THERAPEUTIC APPROACHES
Homoeopathy emphasized on an accurate, unprejudiced observation on the basis of scientific
clinical investigation of disease and the patient as a whole. It focuses on observing the patient
as an individual instead of the disease, stressing the characteristic features of the patient that
distinguish one patient from another patient suffering from the same disease. Homoeopathy
also emphasizes inquiring past illnesses and the medical history of the family to obtain
information from the standpoint of familial and hereditary predispositions to a particular
disease. A homoeopathic physician also evaluate carefully the mental state, as well as
emotional aspects and even try for recognition of unfavorable environmental factors and pay
special attention to factors which aggravate or ameliorate the troubles of the patient. 1
Homoeopathy offers opportunities in the curative management of psychotic, psychoneurotic,
and psychosomatic disorders. Many chronic diseases have a constitutional basis playing an
essential role in facilitating their occurrence and continuation, in this case, a well-selected
constitutional remedy affects them favorably . 4

APPROACH TO EPIDEMIC DISEASE

Approach to epidemic diseases with homoeopathic intervention to the identification of
GENUS EPIDEMICUS, which could be used as a prophylactic and increase immunity and be
used as a therapeutic for the epidemics. GENUS EPIDEMICUS is a homoeopathic remedy
selected on the basis of collected symptoms of patients suffering from the same outbreaks
similar to a large number of patients suffering from that particular epidemic. As the strains of
causative organisms change over a period of time, there are some variations in the
symptomatology. Therefore, in Homoeopathy, GENUS EPIDEMICUS needs to be identified
each time epidemic outbreaks occur, making it more reliable to prevent the disease.
SCOPE & ADVANTAGES

Scope:
Homoeopathy has been used as a therapeutic measure over the year in different diseased conditions
such as Musculoskeletal Disorders, Paediatrics Complaints, Chronic Dermatological problems, Auto-
Immune Disease Conditions, Psychosomatic Disorders, Life Style Disorders, Allergic Conditions, etc.
Homoeopathy is also used as palliative care in conditions like Cancer, Terminal illnesses,
HIV/AIDS, etc., for providing palliative care and improvement in the patient's quality of life.
Clinical research studies show evidence of homoeopathy being effective in several clinical
conditions such as Attention Deficit Hyperactivity Disorder, Autism, Acute Otitis Media
Behavioral Disorders, Benign Prostatic Hyperplasia, Cervical Spondylosis, Chronic Sinusitis,
Chronic Obstructive Pulmonary Diseases, Preclinical Hypothyroidism, Japanese Encephalitis,
Learning Disabilities, Menopausal Complaints, Ovarian Cysts, Scabies, Upper Respiratory
Tract Infections, Urolithiasis, Warts, Withdrawal of Drug Substances etc.8
Some studies conducted through randomized control trials and meta-analyses in conditions
such as Diarrhoea in Children, Respiratory Tract Infections in Children, Attention Deficit
Hyperactivity Disorder, Hay Fever, musculoskeletal Diseases, Osteoarthritis, Premenstrual
Syndrome, Rhinopharyngitis, Rheumatoid Arthritis, Respiratory Allergies, etc. have
generated evidence towards homoeopathy and established that homoeopathy has a
satisfactory role to annihilates these complicated disease conditions.9
Although certain limitations are there in homoeopathic treatment methods, "with a
compelling indication for Surgery and Substitution Therapy or with Advance Pathologies,
where regulative therapy is no longer sufficient. In such cases, it can be used, at best, for
palliative alleviation”.4

Advantages:4
❖ Homoeopathic medicines are safe, effective, and is based upon the natural
substances. With the use of simple substances in minimum doses, it can be safely used
for pregnant women and lactating mothers, infants, and children and in the geriatric
population with minimum toxicological properties.
❖ Instead of having a direct action on the microorganisms, homoeopathic medications
act on the human system (self-protective) to fight the disease process. As such, no
microbial resistance is known to develop against homoeopathic drugs.
❖ The mode of administration of medicines is easy. There are no invasive methods, and
medicines are highly palatable, thereby enhancing their acceptability.
❖ The individualized treatment approach is incompatible with the increasing need for
customized treatment, which is being realized in the modern era.
❖ Treatment is comparatively more cost-effective than other therapeutic systems.
CONCLUSION
The above discussion on the HOMOEOPATHY and its detailed therapeutic aspect shows that
homoeopathy is a safe, gentle, and natural system of healing in the health care system of
India. Homoeopathy medicines are very much affordable and are made from a natural
substance. It is not only useful in chronic deep-rooted and complicated non- surgical diseases
but also it greatly helps in treating acute, even sever acute disease condition as well. In
modern-day scenarios, it is a beneficial therapeutic and preventive aid for lifestyle disorders.
Homeopathy is curative and can be used for preventive, promotive, and palliative purposes,
and it is based upon rehabilitative aspects of the healthcare system. So, in a nutshell,
HOMOEOPATHY, being a cost-effective, affordable, safe & effective treatment procedure,
is one of the best choice of alternative therapy.
REFERENCES
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Homoeopathy. 2018 July-Sept;12(3):109-12.[ evidence homoeopathy]
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www.who.int/medicines/areas/traditional/Homeopathy.pdf
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of AYUSH © 2011 [cited 2012 Sept 04]. Available from http://www.ccrhindia.org/
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20homeopathy%20research%20and%20surveys%20march%202007.

Open Access Review
Article DOI: 10.7759/cureus.35077
Clinical Trials and Clinical Research: A

Comprehensive Review
Review began 02/05/2023
Venkataramana Kandi 1 , Sabitha Vadakedath 2
Review ended 02/13/2023
Published 02/16/2023 1. Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND 2. Biochemistry, Prathima Institute
© Copyright 2023 of Medical Sciences, Karimnagar, IND
Kandi et al. This is an open access article
distributed under the terms of the Creative Corresponding author: Venkataramana Kandi, ramana20021@gmail.com
Commons Attribution License CC-BY 4.0.,
which permits unrestricted use, distribution,
and reproduction in any medium, provided
the original author and source are credited.
Abstract
Clinical research is an alternative terminology used to describe medical research. Clinical research involves
people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical
procedure, or a device as a part of treatment and patient management. Moreover, any research that
evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may
be termed clinical research. However, clinical trials are those studies that assess the potential of a
therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing
incidences of both communicable and non-communicable diseases, and especially after the effects that
Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research
assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs,
devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this
review, we comprehensively describe the critical elements of clinical research that include clinical trial
phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical
concerns.
Categories: Medical Education, Infectious Disease, Public Health

Keywords: ethical concerns, audit, clinical trials, therapeutic drug, efficacy, medical research, clinical research
Introduction And Background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in
treating/preventing/diagnosing a disease or a medical condition [1,2]. Clinical trial includes various phases
that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [3]. Phase 0 and phase 2
are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the
therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance
phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out
in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a
part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table
1.
How to cite this article

Kandi V, Vadakedath S (February 16, 2023) Clinical Trials and Clinical Research: A Comprehensive Review. Cureus 15(2): e35077. DOI
10.7759/cureus.35077
Clinical
Type of the
trial Nature of study
study
phase
Phase Examines too low (1/100th) concentrations (micro-dosing) of the drug for less time. Study the pharmacokinetics
Exploratory
0 and determine the dose for phase I studies. Previously done in animals but now it is carried out in humans.
Phase
I, Around <50 healthy subjects are recruited. Establishes a safe dose range, and the MTD. Examines the
Non-
Phase pharmacokinetic and pharmacodynamic effects. Usually single-center studies. Phase Ia: SAD, and MTD. Duration
therapeutic
Ia, of one week to several months depending on the trial and includes 6-8 groups of 3-6 participants. Phase Ib: MAD
trial
Phase and the dose is gradually narrowed down. Three groups of 8 individuals each.
Ib
Phase
II, Recruiting around 5-100 patients of either sex. Examines the effective dosage and the therapeutic effects on
Phase Exploratory patients. It decides the therapeutic regimen and drug-drug interactions. Usually, multicentre studies. Phase IIa:
IIa, trial Decides the drug dosage, includes 20-30 patients, and takes up to weeks/months. Phase IIb: Studies dose-
Phase response relationship, drug-drug interactions, and comparison with a placebo.
IIb
More than 300 patients (up to 3000) of either sex are recruited in this study and are multicentric trials. Pre-
Therapeutic
Phase marketing phase examines the efficacy and the safety of the drug. Comparison of the test drug with the
confirmatory
III placebo/standard drug. Adverse drug reactions/adverse events are noted. Initiate the process of NDA with
trial
appropriate regulatory agencies like the FDA.
Post-
Phase After approval/post-licensure and post-marketing studies/surveillance studies. Following up on the patients for an
approval
IV exceptionally long time for potential adverse reactions and drug-drug interactions.
study
TABLE 1: The phases, types, and nature of clinical trial studies

This table has been created by the authors.
MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug
administration
Clinical research design has two major types that include non-interventional/observational and
interventional/experimental studies. The non-interventional studies may have a comparator group
(analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental
studies may be either randomized or non-randomized. Clinical trial designs are of several types that include
parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design,
superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are
depicted in Table 2.
2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 2 of 15

Trial design Type of the
Nature of study Advantages/disadvantages
type study
This is the most frequent design wherein each arm of the

The placebo arm does not receive the trial drug,
Parallel Randomized study group is allocated a particular treatment (placebo
so may not get the benefit of it
(an inert substance)/therapeutic drug)
Avoids participant bias in treatment and requires

The patient in this trial gets each drug and the patients
Crossover Randomized a small sample size. This design is not suitable
serve as a control themselves
for research on acute diseases.
Two or more interventions on the participants and the

Non-
Factorial study can provide information on the interactions The study design is complex
randomized
between the drugs
Randomized
The study uses a placebo to understand the
withdrawal Randomized This study evaluates the time/duration of the drug therapy
efficacy of a drug in treating the disease
approach
Post-
Matched
approval Recruit patients with the same characteristics Less variability
pairs
study
TABLE 2: Clinical trial designs, their advantages, and disadvantages

There are different types of clinical trials that include those which are conducted for treatment, prevention,
early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a
disease and its outcomes [4]. They assess whether the drug is able to prevent the disease/condition, the
ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the
disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted
in Figure 1.

FIGURE 1: Pictorial representation of disease diagnosis, treatment, and
prevention
This figure has been created by the authors.
The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained.
The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the
integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the
collection of data. Despite these advantages, adaptive designs have not been universally accepted among
clinical researchers. This could be attributed to the low familiarity of such designs in the research
community. The adaptive designs have been applied during various phases of clinical trials and for different
clinical conditions [5,6]. The adaptive designs applied during different phases are depicted in Figure 2.

FIGURE 2: Pictorial representation of adaptive clinical trial designs
This figure has been created by the authors.
The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19
(COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform
trial wherein multiple treatments can be tested on different patient groups suffering from disease [7].
In this review, we comprehensively discuss the essential elements of clinical research that include the
principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials
of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project
management, clinical trial operations at the investigation site, the essentials of clinical trial experiments
involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.
Review
A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined
population/participant. The clinical research includes a treatment group and a placebo wherein each group
is evaluated for the efficacy of the intervention (improved/not improved) [8].
Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are
potentially biased, and the results of such research are not considered as equally as the controlled studies.
Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is
minimized, and the results are considered reliable. There are different types of randomizations and each one
has clearly defined functions as elaborated in Table 3.

Randomization type Functions
The participants are assigned to a case or a control group based on flipping coin results/computer
Simple randomization
assignment
Block randomization Equal and small groups of both cases and controls
Stratified randomization Randomization based on the age of the participant and other covariates
Co-variate adaptive
Sequential assignment of a new participant into a group based on the covariates
randomization/minimization
Randomization by body halves or One intervention is administered to one-half of the body and the comparator intervention is
paired organs (Split body trials) assigned to another half of the body
Intervention is administered to clusters/groups by randomization to prevent contamination and

Clustered randomization
either active or comparator intervention is administered for each group
Allocation by randomized consent

Patients are allocated to one of the two trial arms
(Zelen trials)
TABLE 3: Different types of randomizations in clinical trials

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a
hypothesis, and perform public health-related research [2,3]. This is majorly carried out by collecting the
data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped
as analytical, observational, and experimental research. Clinical research can also be classified into non-
directed data capture, directed data capture, and drug trials. Clinical research could be prospective or
retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find
treatment, prevent, observe, and diagnose a disease or a medical condition.
Among the various types of clinical research, observational research using a cross-sectional study design is
the most frequently performed clinical research. This type of research is undertaken to analyze the presence
or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined
population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of
intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas
in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials
provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials
are delineated in Table 4.

Type of clinical trial Definition
Randomized trial Study participants are randomly assigned to a group
Open-label Both study subjects and the researchers are aware of the drug being tested
Blinded (single-blind) In single-blind studies, the subject has no idea about the group (test/control) in which they are placed
Double-blind (double-blind) In the double-blind study, the subjects as well as the investigator have no idea about the test/control group
Placebo A substance that appears like a drug but has no active moiety
Add-on An additional drug apart from the clinical trial drug given to a group of study participants
Single center A study being carried out at a particular place/location/center
Multi-center A study is being carried out at multiple places/locations/centers
TABLE 4: Clinical trial methods and terminologies

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on
the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug.
Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength,
and safety as the patented drug [9]. The regulatory requirements and the drug production process are almost
the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United
States of America (USA).
The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of
the generic drug. These studies compare the concentration of the drug at the desired location in the human
body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured
using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed
to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro
(fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [9].
Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and
functioning of institutional review boards (IRBs). It also includes data management and the monitoring of
clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the
information collected by the investigator about each subject participating in a clinical study/trial. According
to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic
document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test
subjects. This information is intended for the sponsor who initiates the clinical study [10].
The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate
and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the
participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites
where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of
the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled
CRFs are checked for their completeness and transported to the sponsor [11].
Effective planning and implementation of a clinical study/trial will influence its success. The clinical study
majorly includes the collection and distribution of the trial data, which is done by the clinical data
management section. The project manager is crucial to effectively plan, organize, and use the best processes
to control and monitor the clinical study [10,11].
The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol,
time limits, and regulatory requirements assume significance while planning a clinical trial. What, when,
how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the
bar and Gantt charts, and maintaining the timelines assume increased significance for success with the
product (study report, statistical report, database) [10,11].
The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a
problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol,
finding a source of funding, designing a patient consent form, forming ethics boards, identifying an

organization, preparing manuals for procedures, quality assurance, investigator training and initiation of
the trial by recruiting the participants [10].
The two most important points to consider before the initiation of the clinical trial include whether there is
a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology
are strong for the results to be reliable to the people [11].
For clinical research to envisage high-quality results, the study design, implementation of the study, quality
assurance in data collection, and alleviation of bias and confounding factors must be robust [12]. Another
important aspect of conducting a clinical trial is improved management of various elements of clinical
research that include human and financial resources. The role of a trial manager to make a successful
clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and
successfully executing the trial. Some qualities of a trial manager include better communication and
motivation, leadership, and strategic, tactical, and operational skills [13].
Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated
by nationally funded research, industry-sponsored research, and clinical research initiated by
individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-
6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical
research [14]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise
research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for
an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related
documents like the case record forms, define the budget, and identify the funding sources.
Other major steps of clinical research include the approval of IRBs, conduction and supervision of the
research, data review, and analysis. Successful clinical research includes various essential elements like a
letter of intent which is the evidence that supports the interest of the researcher to conduct drug research,
timeline, funding source, supplier, and participant characters.
Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical
research to generate quality and accurate data. Each element of the clinical research must have been carried
out according to the standard operating procedure (SOP), which is written/determined before the initiation
of the study and during the preparation of the protocol [15].
The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical
research. The audit, according to the ICH and GCP, is an independent and external team that examines the
process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality
assurance personnel are adequately trained, become trainers if needed, should be good communicators, and
must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the
protocol, and the personnel involved in clinical research (source data verification, monitors) [16].
Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the
application of science, technology, and interpersonal skills [17]. Clinical trial operations are complex, time
and resource-specific that requires extensive planning and coordination, especially for the research which is
conducted at multiple trial centers [18].
Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations.
Previous research had noted that most clinical trials do not meet the participant numbers as decided in the
protocol. Therefore, it is important to identify the potential barriers to patient recruitment [19].
Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies
from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial
to be completed. This study emphasized the need for increased transparency with respect to the costs
associated with the clinical trial and improved collaboration between collaborators and stakeholders [20].
Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of
evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is
conducted according to the protocol, and predefined quality system procedures, following GCP guidelines,
and according to the requirements of regulatory authorities [21].
The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or
personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally
qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the
validity of the investigational drug, and the composition, and functioning of institutional review/ethics

committees. The availability and correctness of the documents like the investigational broacher, informed
consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites
[21].
The data management systems, the data collection software, data backup, recovery, and contingency plans,
alternative data recording methods, security of the data, personnel training in data entry, and the statistical
methods used to analyze the results of the trial are other important responsibilities of the auditor [21,22].
According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory
authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor,
investigator), and the trial site [21,22]. The summary report of the observations of the inspectors is
performed using various forms as listed in Table 5.
Regulatory
(FDA) form Components of the form
number
List of objectionable conditions/processes prepared by the FDA investigator and submitted to the auditee at the end of the
483
inspection
The auditors submit their identity proofs and notice of inspections to the clinical investigators and later document their
482
observations
This document details the fact that the clinical trial is not initiated before 30 days of submitting the IND to the FDA for
approval. The form confirms that the IRB complies with 21 CFR Part 56. The form details the agreement to follow regulatory
1571
requirements and names all the individuals who monitor the conduct and progress of the study and evaluate the safety of the
clinical trial
This form details the fact that the study is conducted after ethics approval ensures that the study is carried out according to
1572
protocol, informed consent, and IRB approval
TABLE 5: The FDA regulatory forms for the submission of inspection results
FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal
regulations
Because protecting data integrity, the rights, safety, and well-being of the study participants are more
significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also,
the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the
sponsors and investigators [21].
The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the
trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company
or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the
principal investigator [21].
An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit
is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance
with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [21].
An audit is performed to review all the available documents related to the IRB approval, investigational
drug, and the documents related to the patient care/case record forms. Other documents that are audited
include the protocol (date, sign, treatment, compliance), informed consent form, treatment
response/outcome, toxic response/adverse event recording, and the accuracy of data entry [22].
Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study,
the site, staff, subject, contracts, data, and document management, patient diary integration, medical
coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and
randomization. The CDMS involves setting a defined start and finishing time, defining study objectives,
setting enrolment and termination criteria, commenting, and managing the study design [23].

Among the various key application areas of clinical trial systems, the data analysis assumes increased
significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS
ensuring the errors with respect to the double data entry are minimized.
Clinical trial data management uses medical coding, which uses terminologies with respect to the
medications and adverse events/serious adverse events that need to be entered into the CDMS. The project
undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are
usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first
subject, and timelines for recording the patient’s data for the first visit.
The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the
locked period after the last subject entry. The planning of the project also includes the modes of collection of
the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to
the central data management sites (fax, scan, courier, etc.) [24].
The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in
the project planning before the start of a clinical study. Review (budget, resources, quality of process,
assessment), measure (turnaround times, training issues), and control (CRF collection and delivery,
incentives, revising the process) are the three important aspects of the implementation of a clinical research
project.
In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a
clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting
audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory
compliance, and promoting improvement in clinical trial research [25]. All the components of a CQA audit
are delineated in Table 6.
Product-specific audits program

Pharmacovigilance audits program
Protocol, CRF, IC, CSR
Supplier
Safety data management
Clinical database
Investigator site
Communications and regulatory reporting
Clinical site visit
Study management
Signal detection and evaluation
SAE reporting
Supplier audits program

Risk management and PV planning
Supplier qualification
Sponsor data audit during the trial

Computerized system
Preferred vendor list after the trials
Process/System audits program

Suppliers
Clinical safety reporting
Data management
Regulatory inspection management program
Clinical supply
Study monitoring Assist with the audit response
Computerized system Pre-inspection audit
TABLE 6: Types of clinical trial audits

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site
The selection of an investigation site is important before starting a clinical trial. It is essential that the
individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and
patient's willingness to accept the protocol design and the timelines set by the regulatory authorities
including the IRBs.
Before conducting clinical research, it is important for an investigator to agree to the terms and conditions
of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the
feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel
available, availability of the study subjects, and benefit to the institution and the investigator is done by the
sponsor during the site selection visit.
The standards of a clinical research trial are ensured by the Council for International Organizations of
Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on
Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World
Medical Association (WMA) [26].
Recommendations for conducting clinical research based on the WMA support the slogan that says, “The
health of my patient will be my first consideration.” According to the International Code of Medical Ethics
(ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be
conducted in the best interest of the person [26].
Basic principles recommended by the Helsinki declaration include the conduction of clinical research only
after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be
performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to
analyze the benefit of research over harm to the participants before initiating the drug trials.
The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and
gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle,
the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the
patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.
Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the
trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that
one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug
from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient
recruitment with one-third of studies enrolling only 5% of the participants [27].
It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken
for improved chances of success. Points to be considered under the feasibility assessment program include if
the disease under the study is related to the population of the geographical region, appropriateness of the
study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and
commitments of the study partners, CROs in respective countries (multi-centric studies) [27].
Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical
preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation
site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems,
and infrastructural aspects) [27].
Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be
defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the
pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.
According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a
novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a
new drug combination, of previously approved drugs.
A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a
comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a
disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs
already approved in other countries are done to establish the efficacy of new drugs [28].
Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices
for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other
material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes

wherein class I uses general controls; class II uses general and special controls, and class III uses general,
special controls, and premarket approvals [28].
The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities
from bench to animal to human clinical studies. The FDA approval for investigational device exemption
(IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies
that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial
endpoints, randomization, monitoring, and statistical analysis plan) [28].
As evidenced by the available literature, there are two types of research that include observational and
experimental research. Experimental research is alternatively known as the true type of research wherein
the research is conducted by the intervention of a new drug/device/method (educational research). Most true
experiments use randomized control trials that remove bias and neutralize the confounding variables that
may interfere with the results of research [28].
The variables that may interfere with the study results are independent variables also called prediction
variables (the intervention), dependent variables (the outcome), and extraneous variables (other
confounding factors that could influence the outside). True experiments have three basic elements that
include manipulation (that influence independent variables), control (over extraneous influencers), and
randomization (unbiased grouping) [29].
Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on
the presence of specific characteristic features. True experiments have all three elements of study design
(manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-
experiments generally have two elements of design (manipulation and control), are prospective, and have
moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization,
are generally retrospective, and have low scientific validity [29].
Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution,
determinants, incidence, prevalence, and impact on health among a defined population. Such studies are
attempted to perceive the status of infectious diseases as well as non-communicable diseases [30].
Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-
control studies, and cohort studies) and experimental studies (randomized control studies) [3,31]. Such
research may pose challenges related to ethics in relation to the social and cultural milieu.
Biomedical research related to human genetics and transplantation research poses an increased threat to
ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The
benefits of human genetic studies are innumerable that include the identification of genetic diseases, in
vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and
social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research
studies use advanced technologies which should be equally available to both economically well-placed and
financially deprived people [32].
Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family
members. The research on genetics may be of various types that include pedigree studies (identifying
abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene
therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human
genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [33]. The
biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and
others [34].
Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be
transmitted among families. The classical epidemiological studies may include single case observations (one
individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-
sectional studies (defined number of individuals), case-control studies (defined number of individuals),
cohort (defined number of individuals), and interventional studies (defined number of individuals) [35].
Genetic studies are of different types that include familial aggregation (case-parent, case-parent-
grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control),
association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control,
exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control,
familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group)
[35].
Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices
assumes increased significance [36]. In view of the unethical research conducted on war soldiers after the
Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible
medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all
the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and
purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should
have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency.
The other essential principles of clinical research involving human subjects as suggested by the Nuremberg
code included benefit to the society, justification of study as noted by the results of the drug experiments on
animals, avoiding even minimal suffering to the study participants, and making sure that the participants
don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified
investigators [37].
During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for
doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the
interests and concerns of the human participants will always prevail over the interests of the society. Later
in 1974, the National Research Act was proposed which made sure that the research proposals are
thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was
proposed by the national commission for the protection of human rights during biomedical and behavioral
research. The Belmont report proposed three core principles during research involving human participants
that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [38]. These
guidelines are universally followed throughout the world during the conduction of clinical research
involving human participants.
ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries.
The ICH conference is conducted once every two years with the participation from the member countries,
observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade
Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the
academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of
the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report,
and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research
Involving Human Subjects was proposed by the CIOMS in association with WHO [39]. The CIOMS protects
the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in
underdeveloped countries [40]. In India, the ethical principles for biomedical research involving human
subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later
amended in the year 2006 [41]. Clinical trial approvals can only be done by the IRB approved by the Drug
Controller General of India (DGCI) as proposed in the year 2013 [42].
Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a
clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study
highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false
positive) and type 2 (false negative) errors [43].
The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous
study which concluded that animal studies may not completely guarantee the safety of the investigational
drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse
reactions in humans [44].
The significance of BE studies to compare branded and generic drugs was reported previously. The
pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a
group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as
compared to the branded drug [45].
To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and
the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1
for a generic drug to be considered as a bioequivalent to a branded drug [46].
Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis
of extended-release formulations of the generic drug appears to be complex. Since the extended-release
formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and
interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the
successful production of generic extended-release drug formulations [47].
Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such
clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment
outcomes/bias, problems of cointerventions, and contaminations [48].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents
was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible
regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be
because a switch from a branded drug to a generic drug in patients may precipitate adverse events as
evidenced by previous reports [49].
Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric
age people, military persons, ethnic minorities, people suffering from incurable diseases, students,
employees, and pregnant women cannot make decisions with respect to participating in a clinical trial,
ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which
include such groups [50].
Conclusions
Clinical research and clinical trials are important from the public health perspective. Clinical research
facilitates scientists, public health administrations, and people to increase their understanding and improve
preparedness with reference to the diseases prevalent in different geographical regions of the world.
Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe
Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging
microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore,
scientists are required to be up to date with the process and procedures of clinical research and trials as
discussed comprehensively in this review.
Additional Information
Disclosures
Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the
following: Payment/services info: All authors have declared that no financial support was received from
any organization for the submitted work. Financial relationships: All authors have declared that they have
no financial relationships at present or within the previous three years with any organizations that might
have an interest in the submitted work. Other relationships: All authors have declared that there are no
other relationships or activities that could appear to have influenced the submitted work.
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Table 3: AYUSH workforce as per IPHS guidelines

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Dr. Asif Sardar

1 Dept. of AYUSH, AIIMS Bhubaneswar

In homoeopathy we follow the "INDIVIDUALISTIC" & "HOLISTIC" approach that simply

Homoeopathic medicine stimulates the entire defense mechanism of disease persons to

As the popularity of homoeopathy treatment grows worldwide, it has become inevitable to

2 Dept. of AYUSH, AIIMS Bhubaneswar

GLOBAL SCENARIO OF HOMOEOPATHY

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APPROACH TO EPIDEMIC DISEASE

SCOPE & ADVANTAGES

4 Dept. of AYUSH, AIIMS Bhubaneswar

3. Manchanda RK. Building quality research evidence in Homoeopathy. Indian J Res

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5. Kaur H, Singh Chalia D, Manchanda RK. Homeopathy in Public Health in India.

6. WHO. Programme on Traditional Medicine. Legal status of traditional medicine and

9. An Overview of Positive Homeopathy Research and Surveys [Internet]. European Network of

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Clinical Trials and Clinical Research: A

Categories: Medical Education, Infectious Disease, Public Health

Introduction And Background

How to cite this article

TABLE 1: The phases, types, and nature of clinical trial studies

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 2 of 15

This is the most frequent design wherein each arm of the

Avoids participant bias in treatment and requires

Two or more interventions on the participants and the

TABLE 2: Clinical trial designs, their advantages, and disadvantages

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 3 of 15

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 4 of 15

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 5 of 15

Intervention is administered to clusters/groups by randomization to prevent contamination and

Allocation by randomized consent

TABLE 3: Different types of randomizations in clinical trials

Principles of clinical trial/research

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 6 of 15

Randomized trial Study participants are randomly assigned to a group

Single center A study being carried out at a particular place/location/center

Multi-center A study is being carried out at multiple places/locations/centers

TABLE 4: Clinical trial methods and terminologies

Planning clinical trial/research

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 7 of 15

Practical aspects of a clinical trial operations

Clinical trial applications, monitoring, and audit

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Clinical trial data analysis, regulatory audits, and project management

2023 Kandi et al. Cureus 15(2): e35077. DOI 10.7759/cureus.35077 9 of 15

Product-specific audits program

Supplier audits program

Sponsor data audit during the trial

Process/System audits program

Study monitoring Assist with the audit response

Computerized system Pre-inspection audit