Research finds over-recruitment of Indian participants in global clinical trials

Numerous worldwide medical studies aimed at testing medicines have enrolled more people from India than necessary, according to researchers. They are urging drug regulators to investigate and prevent the potential exploitation of Indian participants.

A study revealed that out of 424 multinational clinical trials sponsored by foreign organizations to evaluate potential drugs for conditions like asthma, bacterial infections, and cancer, 26 of them had recruited or planned to recruit over 60% of their volunteers from India.

As per a report, Gayatri Saberwal, a policy research professor at the Institute of Bioinformatics and Applied Biotechnology in Bangalore, expressed concerns about the possibility of India being over-recruited due to lax oversight by ethics committees that approve these trials.

Ethics committees, comprised of medical experts, social scientists, and legal professionals, are responsible for reviewing proposals for clinical trials, assessing the risks to volunteers, and ensuring informed consent is obtained.

Saberwal questioned the rationale behind such a high percentage of Indian participants in global trials, stating, “It is not always clear why global trials should have greater than 60 per cent volunteers from India.”

However, health sector analysts pointed out that India only accounts for 3% of clinical trials worldwide while dealing with 15% of the global burden of prevalent diseases like respiratory infections, cardiovascular disorders, and diabetes.

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Regulatory changes in India since 2013 have led to increased clinical trial activity, as reported by PricewaterhouseCoopers and the US India Chamber of Commerce. The report stated that the number of clinical trials initiated in India by the top 20 pharmaceutical companies increased from 175 between 2014 and 2016 to 296 from 2020 to 2022.

In multinational trials, Saberwal recommended that the proportion of participants from any single country should ideally not exceed 50%, with the actual percentage depending on the number of countries involved. For example, a two-country trial should have 50% of participants in each country, a three-country trial 33% from each, and so on.

This distribution pattern helps ensure a fair distribution of risks and potential benefits among volunteers from all participating countries.

Saberwal and her colleagues from the Institute of Bioinformatics and Applied Biotechnology and the Centre for Ethics, Yenepoya University, conducted a study analyzing volunteer recruitment in 424 multinational clinical trials sponsored by foreign organizations from January 2013 to December 2020. They discovered that six of the completed trials and 20 of the incomplete trials had either planned to recruit or had actually recruited more than 60% of participants from India.

Eighteen of the 20 incomplete trials were not related to health disorders that were particularly prevalent in India. These trials were sponsored by companies from Australia, Austria, Italy, Switzerland, the United States, Brazil, Russia, and Malaysia.

Saberwal and her colleagues have called on drug regulators to investigate why some global trials had such a high percentage of Indian participants, particularly when sponsors were from populous nations like Brazil and Russia. They argued that it should be possible for these nations to find trial participants within their own borders.