Clinical Trials

What is a clinical Trial?

It is a way to determine the safety and efficacy of a drug by seeing the effect on participants. All the drugs from a simple cough to life threatening cancer are outcome of painstaking clinical trials.

Why we need it?

·       For development of cheaper and effective drugs for poor people

·       For advancement of pharmaceutical research

·       To develop the drugs for life threatening disease such as cancer, HIV-AIDS etc.

·       Efficacy of drug also depends on the ethnicity of population. For example cancer drug Iressa, effective of Japanese population but not on Caucasian population. Hence, India too has its representation in clinical trials. (India- 2%, China- 9%)

·       USA-FDA has approved the outcomes of foreign clinical trials valid. Hence keeping in view the cost and efficiency, a lot of drugs will be tried in India. (Diverse population hence a large genetic pool)

Why Clinical Trials in news?

Ø More then 500 people died in year 2012 due to clinical trials, so NGO, PIL and other has started their crusade again clinical trials. They only seeing the dark side of clinical trials and portraying it as the pharma company are using poor people as a tool to test their drugs and then make profit. In response to this controversy, SC has asked government the details of clinical trials in India.

Ø Lack of regulation of clinical trials has lead to some lapses, however public is painting the whole trials industry with same brush.

Regulators for Clinical Trials:

Ø Contract Research Organization (CRO)

Ø Central Drug Standard Control Organization (CDSCO)

But CDSCO allegedly in collusion with drug companies/ doctors give approval to drugs without testing and verifying the safety and efficacy through clinical trials. So we need transparency, accountability and accessibility in the process of approval of new drugs.

(USA- FDA, UK- Medical Commission)