Taking the ‘fear factor’ out of clinical trials

It’s been a little over a month since Chirag Trivedi took charge as President of the Indian Society for Clinical Research (ISCR), a body of professionals involved with the research, development and testing of medicines before it hits the marketplace.

And one of the tasks he hopes to achieve during his time in office is to take the “fear factor” out of clinical trials. “Clinical trials should not be a dreaded word,” says the soft-spoken Trivedi, straining to speak above the din of people having lunch in a South Mumbai restaurant. At pains to counter the perception that patients get exploited in clinical trial by the pharmaceutical industry, he says, patients in fact get better medical attention when they are in a clinical trial as compared to a regular visit to a doctor.

The mood on the ground, though, is cautious. The very mention of clinical trials puts many on their guard, given past reports of trials gone awry or patients not being adequately compensated. About three years ago, the Supreme Court had directed the government to bring in stronger rules to protect patient-volunteers participating in trials. Ever since, the regulatory landscape for trials has been changing in favour of tighter norms and governance.

Much has changed in terms of streamlining the three-tier approval system for trials or getting more ethics committees, agrees Trivedi. But much more remains to be done. Draft guidelines in 2015 had proposed a system of pre-approval consultations that involved discussions between the regulator and companies undertaking the trial. This would give companies a clear idea of what was required of them to get a go-ahead and, in the process, approval timelines could be reduced, he explains. This is something Trivedi will pursue.

Approval timelines have improved to about six months, but they still lag behind those in other countries, which approve trials in three months or less, he says. This results in India missing out on global trials on breakthrough medicines, he points out. Companies sponsoring trials seek a predictable and transparent regulatory environment, and delays will only see trials move to Malaysia, Singapore, China or South Korea, adds Trivedi.

Other patient-safeguards that need clarity include the requirement of an audio-visual recording of a trial-participant giving “informed consent”; compensation of a volunteer in case of an adverse incident, and so on.

Some researchers say volunteers are apprehensive about being recorded while giving consent for fear of their privacy being violated if the recordings fall into the wrong hands. Government clarifications that it would be required only of “vulnerable” populations has led patient groups to question the definition of “vulnerable”. Similarly, the subject of compensation brings in divergent views as it becomes difficult to establish the link between an ‘adverse event’ and the trial.

Patient-group representatives further point out that accreditation of ethics committees and clinical research organisations continues to hang fire.

Amit Sengupta with Jan Swasthya Abhiyan, a people’s health movement, acknowledges that the regulatory landscape has changed, but is uncomfortable with the argument that patients in a trial are treated better than other ordinary people. This only reflects the vulnerability of patients in India in the absence of a robust public health system, he says. It ends up becoming an incentive to participate in a trial and goes against the grain of a trial, he adds.

International rules mandate that access to a new drug should be given not just to trial participants but also to the local community. That is not the case, as new drugs are patented and priced expensively as they command a monopoly market.

Public health systems are not robust, there is a dearth of trained human resource for ethics committees to oversee trials, insurance is not mandatory, and trial sponsors have an overwhelming financial capacity, says Sengupta. That is a strong case to say that India is not ready to open up for large global trials, he says.

With such divergent views still being expressed, ISCR’s Trivedi will have to take on board and work with these opinions as well to make clinical trials an engagement that a patient can truly benefit from.

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