Thirty-five-year-old Ritu Bhalla was twice diagnosed with blood cancer, at the ages of four and 11. She developed chronic hepatitis B as a long-term side-effect after cancer treatment.

Three years ago, while waiting for a follow up consultation in a hospital in Delhi, a woman who was not part of the hospital staff approached Bhalla—she asked her to provide a blood sample and sign a consent sheet to take part in a gastrointestinal clinical trial. But she did not explain why.

Bhalla asked for the information sheet or details of the study, but that only annoyed the woman, who she assumed was a trial coordinator, she said. Since no one came forward to explain the study, she refused to participate.

Experts say Bhalla’s experience isn’t a one-off occurrence. This is even as India’s regulatory framework covering clinical trials was significantly strengthened after the Supreme Court’s intervention in 2013, and subsequent amendments were made to the Drugs & Cosmetics Rules.

New rules include provisions for compensation to trial participants, and recording consent on video, especially among vulnerable populations. These, and mandatory registration of ethics committees with the central licensing authority (CDSCO) have improved safeguards for participants, said Poonam Bagai, founder and chairman, CanKids…KidsCan, which also hosts the Pediatric Cancer Research Institute (pCRI), an initiative focused on patient-centred paediatric oncology research.

However, “the video recording of the consent process of vulnerable trial participants isn’t happening,” said Amulya Nidhi of the Swasthya Adhikar Manch, a not-for-profit working in the clinical trials space.

Bagai said the consent process still often lacks true comprehensibility, limiting informed decision-making. “Consent forms may exist, but the key question is whether patients and families genuinely understand what participation means,” she said, noting that low health literacy remains a significant barrier in India. “Consent or assent for paediatric populations is another important area to address.”

Studies such as this conducted among rural adolescents and this among hypertensive adults show that anywhere between 60 percent and 75 percent of the population is insufficiently informed.

“Many patients who participate in clinical trials in India aren’t aware that they could suffer an adverse drug reaction, contrary to getting better, nor are they aware of their rights in such an eventuality,” said Nidhi.

Further, “the Supreme Court has recommended the establishment of an apex committee to approve new clinical trials, and for those approvals to be based on a risk-benefit-analysis, on the innovation quotient of the new therapy and its usefulness versus existing therapies, and on the unmet medical needs of the country. Still, no such apex committee meeting has happened; and trials are being independently approved,” said Nidhi.

As India moves to expand clinical trials, with the 2026-27 budget allocating Rs 10,000 crore over five years to strengthen biopharma and establish 1,000 accredited new clinical trial sites, there is a pressing need to improve patient awareness and ensure their rights are upheld.

To successfully scale clinical trials, a mindset shift from ‘guinea pig’ to ‘aware patient’ and the promotion of active patient participation is key, said Pooja Sharma, CEO, APAR Health, an organisation working to promote patient-centric research.

Awareness must to eliminate vulnerability among potential participants

Low health literacy can make families more vulnerable, especially at emotionally difficult moments such as a serious diagnosis like cancer, Bagai said.

“At the same time, limited understanding may also prevent families from considering participation in legitimate research that could offer meaningful treatment opportunities,” she added.

National........

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