Technology to make clinical trial process transparent
For the first time in India, some CROs and a few pharma companies have begun filming the process of ‘informed consent’ — the industry lingo for volunteers in trials being informed of the risks and agreeing to the trial process.
Moreover, the Association of Clinical Research Organisations (ACRO), an apex body of CROs, is creating a national database of volunteers to keep a close watch on those who participate in trials, especially healthy volunteers in BA/BE trials (bio-availability or bio-equivalence trials), to ensure top standards are adhered to in recruiting volunteers for studies. BA/BE studies are conducted on healthy volunteers as part of the FDA’s requirements before a drug is launched in the market.
“We have started filming the informed consent process in BA/BE studies,” says Apurva Shah, group managing director of Veeda Clinical Research, one of India's largest CROs, and chairman of ACRO. “This protects everyone, especially in the context of the negative publicity the industry is being afflicted with at present.”
Interestingly, the industry is resorting to the new practice although India’s drug controller does not insist on filming of informed consent. “The government has to be proactive and issue guidelines for filming consent to make this a success,” Shah adds.
Recently, the Supreme Court asked the government to
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