Page 44 - Insurance Times June 2021

3. Foreign drug companies and others have started d. To test the safety and effectiveness of new treatments/
conducting trials in India for new vaccines at the same procedures
time that the trials of the same phase are being
conducted elsewhere. 1. Clinical trials involves -
a. Treatment trials (new drug or combination of
4. This change is expected to fuel the growth of clinical
drugs, new approaches or line of treatment)
trial industry in India.
5. Testing new drugs in US and other Western countries is b. Prevention trials (Better ways of preventing disease
becoming difficult for various reasons, like- or disease from returning)
- Strict regulations existing 2. Clinical trials answers two important questions
a. Is the new treatment safe?
- Elaborate safety norms to be adopted
- Compensation requirements are reasonably high b. Is the new treatment effective?
- Illiteracy & ignorance of populace like India - is 3. Such studies are vital to the development of new
absent there treatments for disease such as Cancer
4. It helps the doctor to learn what is safe and effective
- Strict judicial environments are Prevailing
in treating disease.
- Huge population and dire individual need / urge for
vaccination is absent (i.e. not like India) 5. Today, vaccines, drugs and medical devices must go
through several phases of clinical trials before being
- Recruitment of research subjects - expensive and
approved for use.
slow
- R & D activities of big global drug and A Clinical Trial may include -
pharmaceutical companies are thus getting 1. Treatment trials;
affected.
2. Prevention trials;
Hence, these Clinical Trial Processes are being outsourced 3. Diagnostic trials;
to the developing countries like India, Thailand, etc. as China
4. Screening trails;
is being now out of control.
5. Quality of life trials.
Country attractiveness index for conducting
Exposure to clinical liability suit:
trials: From liability stand point there are four parties involved in
Here the five key areas are - clinical trials:
a. Availability of patients / research subject 1. The sponsor Company testing its new product /
b. Cost procedure
c. Relevant expertise 2. The clinician that actually conduct the study on behalf
d. Regulatory environment of the sponsor
e. Infrastructure. 3. Clinical Research Organization (CRO) that helps the
sponsor manage the study
India easily fulfills these requirements and hence is the most
favourable destination for such clinical trials. 4. The institution where the study is actually carried.

What is a clinical trial process? Phases of clinical trials:
It is basically - A clinical trial is conducted in four phases. These studies are
a. Clinical trials are people based studies as opposed to focused on human being - the first requirement here is to
animal or lab based for testing new vaccines / drugs and involve people as participant in the trials through application
procedure. of newly invented vaccine/drug and simultaneously ensure
the physical safety of those people engaged in the process
b. Medical research studies involving people
against the administration of the vaccine/drug.
c. To test the efficacy of a drug by testing it in human
beings. Each phase is designed to answer certain question, while

44 The Insurance Times, June 2021