Risks of Clinical Drug Trials

Risks of Clinical Drug Trials
Clinical trials of new drugs and treatments come with benefits as well as risks. If you have suffered
adverse side effects due to a clinical drug trial, an experienced personal injury lawyer can advise you
as to your options.
What Is a Clinical Trial?
Researchers conduct clinical trials to test the efficacy of new drugs on patients. The scientists have
usually completed exhaustive tests, including animal testing, and now need to determine if the drug
works as well as they believe it will treat a specific disease or condition.
Why Do People Participate in Clinical Trials?
People choose to participate in clinical trials for many reasons. The most obvious reason is to treat or
cure a disease they suffer from but have not been able to find any relief.
Clinical trial participation also allows patients to take a more active and direct role in his or her own
health care.
Patients also may receive more regular checkups at no charge while part of the clinical trial, including
certain types of medical care that generally the patient must pay for out of pocket.
Others may want to help others by proving or disproving the effects of a new drug.
What Are the Risks Associated with Clinical Trials?
One of the critical risks of being a part of a clinical trial is potential side effects. The effects could be
uncomfortable or even severe.
Another risk is the treatment may not work or be as effective as the treatment you received before participating
in the trial.
Participants may also belong to the placebo or control group that does not receive the new drug, but only a
harmless facsimile or you may continue with your current treatment and be monitored and compared to those
on the new drug.
Finally, the numerous doctor appointments and checkups may become a significant inconvenience and
consume a lot of your time. The trial may require short hospital stays also.
How Safe are Clinical Trials?
The Food and Drug Administration and other government agencies have strict safety guidelines that the
researcher must follow during clinical trials.
Congress has passed several laws applicable to clinical trial safety.
The government carefully reviews and approves each clinical trial before the studies can start. The researchers
must provide and follow strict safety protocols for drug testing.
Each step is overseen by the Institutional Review Board (IRB).
What Does the IRB Do?
Member of the IRB include doctors, scientists, and members of the public whose sole purpose is to ensure
that the risks to participants are minimal.
The IRB regularly reviews the study as it is being conducted to ensure the safety of the people involved.
Other government agencies also oversee the clinical trials, including the Data and Safety Monitoring
Committee, comprised of experts in the field of study related to the trial.
Both groups have the authority to stop the clinical trial immediately should their reviews indicate a safety
concern.
What Are the Four Stages of a Clinical Trial?
Clinical trials are formally divided into four stages. A new drug must successfully pass each step before the
FDA approves it:
Phase I: Small Group Testing
During phase I, the drug is tested on a small number, 20-80, of individuals to determine if there are any side
effects and what dosage is safest.
Phase II: Effectiveness
Phase II concentrates on determining the effectiveness of the drug. Typically between 100-300 participants are
involved in Phase II testing.
This phase can last several years, attempting to determine how effective the drug is in treating a specific
condition.
Phase III: Additional Safety and Effectiveness Study
Phase III can involve up to several thousand people. This phase strives to determine the effect of the drug on
different populations, the effect of various dosages and the safety of the drug.
Phase IV: Post-FDA Approval
During Phase IV, the effectiveness and safety of the drug are monitored for several years to determine if
there are any long-term adverse effects.
Thank You
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Risks of Clinical Drug Trials

Uploaded by

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Risks of Clinical Drug Trials

What Is a Clinical Trial?

Why Do People Participate in Clinical Trials?

What Are the Risks Associated with Clinical Trials?

How Safe are Clinical Trials?

What Does the IRB Do?

Phase I: Small Group Testing

Phase II: Effectiveness

Phase IV: Post-FDA Approval

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