Given that all trials carry an element of risk, experts believe that there is an “unfair” burden-benefit ratio on the Indian population when sponsors conducting trials in multiple countries recruit too many patients from the country, said the study published in PLOS One journal.
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“The Indian drug regulator needs to be particularly alert to the planned, or actual, over-recruitment of participants from India,” the researchers said in the study.
Gayatri Saberwal, a policy research professor at Institute of Bioinformatics and Applied Biotechnology in Bengaluru, and her colleagues conducted the study analysing recruitment of volunteers in 424 multinational clinical trials sponsored by foreign organisations – 62 completed trials and 362 incomplete trials – from January 2013 to December 2020.
They found that in the trials 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.
They also found that several studies that were probably completed were not updated in CTRI in a timely manner, pointing at the laxity on the part of the ethics committee that approved the trials.
“Undoubtedly, trials conducted in India would have undergone review by ethics committees. However, it is known that the processing of a trial proposal by an ethics committee may be perfunctory,” the study said.
The researchers said that even for those medical conditions such as uveitis, schizophrenia, Covid-19 infection, and haemorrhoids, which are well distributed around, the planning to recruit such a large fraction of trial participants from the country was not “justified”.
“All trials in India have also received regulatory permission, if relevant. Here, too, it is known that permission may have been granted in a casual manner,” it added.
The researchers stated that it is difficult to justify trials that were sponsored by those based in Brazil, Malaysia or Russia since these are populous nations and it should be possible for their companies to find trial participants domestically. “Likewise, organisations based in Western nations ought to be able to find recruitees in many countries if the medical condition is found around the world,” it said.