Covid-19 vaccine trials expose regulatory cracks

PT Jyothi Datta | Updated on January 24, 2021

Shot in the arm: Doctors at a Bhopal hospital after taking the vaccine   -  THE HINDU/ AM FARUQUI

Volunteers complain that the patient voice continues to be lost in the din; oversight committees must ensure patient is safe

The similarities are unsettling. Volunteers alleging that they did not know they were part of a clinical trial. A cloud over their consent, and whether it was taken as mandated by the law. And the location, Bhopal.

These are complaints from volunteers who participated in a Covid-19 vaccine trial at a Bhopal Hospital.

But not too long ago, similar complaints from Indore and Bhopal had rocked the entire clinical trial ecosystem in the country. A watershed development, it led to the Centre tightening laws that governed clinical trials, including bringing in audio-visual consent and reviews by subject expert committees. Measures that were brought in under the watchful eye of the Supreme Court.

But recent incidents involving the Covid-19 vaccine trials have exposed regulatory cracks. And advocacy groups and counsel for the volunteers complain that the patient voice continues to be lost in the din.

“It’s been 10 years,” says Amulya Nidhi of Swasthya Adhikar Manch (SAM), a non-profit body, regretting the repetitive nature of complaints involving the rights of the volunteers or patients participating in clinical trials. SAM had approached the Supreme Court in 2012, following which the rules were tightened.

“A clinical trial needs to fulfil three criteria: Cater to an unmet medical need, be innovative and its benefits need to outweigh risks,” Nidhi explains, adding that transparency, however, continues to elude clinical trials.

In fact, it only gets more tricky. One of the vaccines received an approval in the “clinical trial mode”, a caveat that has ramifications when it comes to serious adverse events and compensation, if required. Against this backdrop, doctors and health workers are getting vaccinated, but some are seeking greater clarity.

The Bhopal trial incident involves Bharat Biotech’s vaccine, Covaxin, and its emergency approval was given in the “clinical trial mode”. But the Serum Institute (Astrazeneca-OxfordUniversity) vaccine also faced trial issues, when a volunteer alleged side-effects linked to the vaccine. Both companies and hospitals involved with the respective trials have, however, said the adverse events experienced by the volunteers were not linked to the vaccine.

Incidentally, the Indian Council of Medical Research (ICMR) collaborates on both the vaccines. Questioning its silence on the allegations coming from volunteers, health activist Rachna Dhingra says that as the organisation which sets rules for bio-medical research, ICMR should clear the air when complaints are made on trial procedures, follow-ups and so on.

Pointing to inherent loop-holes, she says that patient follow-ups are done over the phone, which may be with one member of the family who may be unaware of the side-effects experienced by the member who participated in the trial. Dhingra is with the Bhopal Group for Information and Action, another voluntary organisation.

The primary job of the ethics committee, which oversees the trial, is to protect the patient, says Anant Bhan, a researcher on global health, bioethics and health policy.

While mistakes can happen, it is for these oversight committees to ensure the patient is safe and complaints are redressed as mandated by the law.

There are, however, several layers of experts to review a trial and enough outside representatives to keep the process independent, holds Chirag Trivedi, president, Indian Society for Clinical Research, an association of clinical research industry professionals. He explains that there are legal avenues for patients to raise concerns on their trial and the process has worked. “We have many more diseases to conquer, and only if we do it right can we build confidence,” he says.

Building trust

While the Indian clinical trial laws have compensation formulas written into it, some clinical researchers are calling for a “no-fault” compensation to build trust among patients/volunteers and in the long term interest of research.

Virologist Shahid Jameel underlines the importance of establishing causality through a thorough and transparent investigation. “It builds trust,” he says, urging clear communication at all levels.

“Vaccines are a product of science and work on science and evidence. Don’t create smoke-screens around it, as that will erode the trust,” says Jameel, director, Trivedi School of Biosciences, Ashoka University.

Volunteers, he stresses, usually take part in a trial out of the goodness of their heart. “So, in the interest of clinical trials, volunteers too need to be protected. It is a symbiotic relationship and not us versus them,” he says.

Published on January 24, 2021

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