It Has Been A Defining Decade For Clinical Trials

There is greater focus on patient interest now, but more ground has to be covered

- Pt Jyothi Datta

No bad news is good news, says the Indian Society for Clinical Research’s president Chirag Trivedi, indicating that the environment that prevails around clinical research in the country today is the most “balanced” period, yet. (Clinical trials involve the testing of medicines or treatment on humans.)

The last decade has been a “defining one” for clinical trials, with rules being fine-tuned in 2015 to take care of patient interest alongside work done by researchers, he says. The compensation formula too has been working well, he observes, with ₹18 crore being paid to patients in the 2013-18 period for incidents linked to trials. But this was not the case in 2013, when the Supreme Court halted clinical trials in the country until stringent rules were in place. And there were disconcerting incidents or “bad news” aplenty then, forcing health advocacy groups to move Court and draw attention to incidents of malpractice, absence of consent and death linked to clinical trials done in the country.

Under the apex court’s watch, the regulatory framework governing it was strengthened and subject expert committees were brought in, audio-visual consent was suggested and registration and accreditation of ethics committees were also proposed, among other things.