It has been a defining decade for clinical trials

PT Jyothi Datta | Updated on January 17, 2020

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

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.

While some good may have emerged from that, health advocacy groups like the Swasthya Adhikar Manch (who raised trial concerns at the apex court) say that transparency still eludes the system, especially for the patient. And that becomes worrisome as the clinical trial compensation formula, for instance, becomes a point of consideration in ongoing discussions on medical devices.

ISCR’s Chirag, though, is optimistic that incidents of bad industry practices seen 6-7 years ago are all but behind them. The practice of taking audio-visual consent is operational in the category of people where it is required and regulatory processes have become more transparent, he says. “Patient consent has been sanctified,” he adds, emphatically.

The year 2013 was a “watershed” and the crackdown on trials saw the number done in the country drop from about 500-odd to 17. In 2019, the number of trials done has clawed back to about 160, with 90-odd being global trials.

Clinical trial had missed its target in 2010, when it was projected to touch $1.5 billion. “We are not going to see that number too soon,” says Chirag. Industry representatives peg the present value in the $300-400 million range.

As clinical trial rules go through many iterations, the last being March 2019, Chirag says the 90-day approval time for a trial is comparable with anywhere in the world, making India competitive again. Research for drugs addressing rare diseases is being given regulatory support and there are waivers for drugs that are approved in others markets, with strong data to back it and with no report of adverse events. The company then would have to follow up with monitoring the medicine in a local population, he says.

Case for transparency

And yet, there are incidents like that involving the Malpani Hospital in Rajasthan (2018), where initial reports suggested data falsification and questionable recruitment of patients, something the hospital denied. But as is often the case with clinical trial investigations, it all falls silent. Little is made public by the regulator, if indeed there was wrong-doing.

SAM co-convenor Amulya Nidhi points to questionable incidents being reported from across the country, despite their long legal battle for transparency. Clinical trials need to meet three criteria indicated by the Court — of addressing an unmet medical need of the country, being more innovative than an existing therapy and being beneficial to the local population. But that’s not the case, he alleges. Trials here are not on medicines needed for locals, and the other medicines are not affordable, says Amulya. Data is not available on compensation paid, he says, adding it is not confidential if it involved a death. And there have been over 5,000 deaths between 2005 and 2018, he alleges.

SAM co-ordinator Chinmay Mishra adds that compensation needs to be set aside for patients over a certain age or risk profile, in case of death, without quibbling over whether it was during or due to the clinical trial.

Fast-tracking clearances for approved drugs and softening the scrutiny for academic research work as a ‘back-door entry’ for corporates.

Both sides accept that patients need access to new drugs. But as the regulatory landscape evolves and industry works to improve research capabilities, the clinical trial framework will have to keep patients at the heart of all initiatives to be able to keep the faith in it.

Published on January 17, 2020

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