Stung by widespread criticism of alleged lax standards in conducting clinical trials in the country, clinical research organisations (CROs), which conduct human drug trials on behalf of pharma companies, have resorted to technology to make the process more 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 furnish data on the extent of clinical trials happening in the country, side-effects and compensation to patients after reports of deaths in clinical trails surfaced, with NGOs and some parliamentarians holding pharma companies, CROs and some doctors responsible for the malaise.
This has also sparked an intense public debate on the subject, with pharma companies and top CROs calling for a more balanced view of human trials by the authorities and the courts, since no new drugs can be launched sans trials.
In the meantime, the industry came under pressure, with companies shifting trials to other geographies. While India conducted 505 global and local trials in 2010, it nearly halved to 271 in 2011.
Since informed consent is the most sensitive part in the clinical trial process, the video-recording of the process, where the volunteer or the patient completes a form and puts her signature or thumb impression, is expected to