Researchers raise concern over over-recruitment of Indian volunteers in clinical trials

Researchers claim that more Indian volunteers than would have been needed for a fair distribution of volunteers in several international clinical studies to evaluate medications. They are pleading with drug authorities to look into this and rule out "exploitation" of Indian volunteers.

Researchers discovered that 26 of 424 global clinical trials sponsored by foreign parties to assess potential treatments for cancer, asthma, bacterial infections, and other diseases had recruited or intended to recruit 60% or more of the trial participants from India.

According to Gayatri Saberwal, professor of policy research at the Institute of Bioinformatics and Applied Biotechnology (IBAB), Bangalore, "we need to be aware about the possibility of over-recruitment from India, made possible by casual or perfunctory oversight by ethics committees that approve trials."

The ethics committees of medical colleges and hospitals are panels of medical professionals, social scientists, and legal experts tasked with reviewing clinical trial proposal and determining whether the trials are justified, the risks to the volunteers are within acceptable limits, and the volunteers have given their informed consent.

The Telegraph quoted Saberwal as saying, "It is not always clear why global trials should have more than 60% volunteers from India."

However, according to analysts in the health sector, India only contributes 3% of worldwide clinical trials while carrying 15% of the burden of high-prevalence diseases like diabetes, cardiovascular disease, and respiratory infections.

According to a research on clinical trial opportunities in India published earlier this year by PricewaterhouseCoopers and the US India Chamber of Commerce, legislative reforms in India since 2013 have sparked an increase in trial activity.

The top 20 pharmaceutical companies reportedly started 296 clinical trials in India between 2020 and 2022, up from 175 over the three-year period of 2014 to 2016.

According to Saberwal, the percentage of participants from one country in a global study should ideally not be higher than 50%; the actual percentage will depend on how many nations are involved in the experiment. For example, a two-country study should contain 50% of participants in one nation and 50% in the other.

In a three-country experiment, 33% of the volunteers must come from each nation; in a four-country trial, 25% of the volunteers must come from each nation. Such a distribution strategy permits a fair allocation of risks and potential rewards among participants from all participating countries because trials may carry dangers.

Over the eight-year period from January 2013 to December 2020, Saberwal and her colleagues from the IBAB and the Centre for Ethics, Yenepoya University, Mangalore, examined volunteer recruitment patterns in 424 multinational clinical trials with foreign sponsors, 62 of which were completed and 362 of which remained unfinished.

In 6 of the 62 completed trials and 20 of the 362 unfinished trials, they discovered that at least 60% of the participants were to be from India. The study was released by the researchers in the PLOS One publication.

Of the 20 trials that were not completed, 18 did not involve medical conditions that were "preferentially prevalent" in India. Ten of these 18 studies were sponsored by businesses in Australia, Austria, Italy, Switzerland, and the US; the other eight trials were financed by non-Western businesses in Brazil, Russia, and Malaysia.

For instance, Brazilian corporations funded research on breast and prostate cancer while Russian companies supported asthma studies in India.

Saberwal and her coworkers have requested pharma authorities to look into why at least 60% of participants in several international trials were from India.

"Given that Brazil and Russia are both populous countries, it is challenging to explain trials (in India) that were sponsored by firms in those countries... Finding trial participants (in their own countries) ought to be possible, the researchers noted in the journal.