Page 45 - Insurance Times June 2021

trying to ensure the safety of the people taking part. The Basically findings during the starting of
phases involved are -
Phase -I: In Phase I, it tests the safety of the product, this 21st century shows -
determination of safe dosage and identification of side
effects. In Phase I of Clinical Trials, researchers test a new
drug or treatment in a small group of people (20-80)
volunteers for the first time to evaluate its safety, determine
a safe dosage range, and identify side effects.

Phase-II: In Phase II of Clinical Trials, the experimental
vaccine/drug or treatment is given to or a procedure is
performed on a larger group of people (100 to 300) to
further measure the effectiveness and to further evaluate
its safety.

Phase-III: Phase III studies, the study drug or treatment is
given to large groups of people (1,000-3,000) to confirm its
effectiveness, monitor side effects, compare it to commonly
used treatments, and collect information that will allow to Now india emerges as the focus for 1st trial
check that trial demonstrate large scale efficacy of the as free volunteers are easily available.
product and is conducted on more & more individuals in
many places across the country at the same time.
What is informed consent?
Phase-IV: After the vaccine/drug is approved, treatment or Informed consent is the process of learning the key facts
medical procedure is marketed; the testing continues to about a clinical trial before the subject volunteer decides
provide additional evidence of efficacy, effects on various whether or not to participate in the trial. These facts
populations, effect with long term use, etc. the drug or include:
treatment to be used safely. Phase IV studies continue 1. Why the research is being done?
testing the study drug or treatment to collect information 2. What the researchers want to accomplish?
about their effect in various populations and any side effects 3. What will be done during the trial and for how long?
associated with long-term use.
4. What risks are involved in the trial?
Now the issue arises - 5. What benefits can be expected from the trial?
1. Phase I - Is the treatment safe?
6. What other treatments are available?
2. Phase II - Does it work?
7. The fact that the subject has the right to leave the trial
3. Phase III - Is it effective or better than what is already at any time.
available?
8. Each party involved in the clinical trial has legal and
4. Phase IV - What else do we need to know? moral responsibility towards the human subject.
9. The parties involved in clinical trial have real &
significant exposure to liability because the trial involves
testing humans. Generally, the target of litigation is
clinical investigators and the research institution
involved. Companies that sponsor the trial are also
exposed to the risk of litigation - improper disclosure,
conflict of interest, violation of good clinical practice.
Compliance of regulatory standard and best practices
are the essential requirements. In today's litigation
society, after all, parties will be sued, regardless of
whom or what caused the injury or death.

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