Clinical research in India is presently going through a rough phase and May 20 saw yet another effort by industry to give clinical research a fresh context.
To mark International Clinical Trials Day, the Indian Society for Clinical Research (ISCR) chose to ‘highlight the positive difference’ made by clinical research. The audience was an assorted mix: mostly clinicians, clinical researchers, representatives of CROs, a few reporters. Going with the chosen theme, the panelists made the pitch that perceptions of clinical research and trials needed to change in India.But beyond the usual rhetoric, the discussion served to further air some key issues. The consent process and compensation guidelines seemed to be at the top of the list of concerns, with suggestions ranging from filming of the consent process (and the logistical nightmare this might create), maintaining confidentiality, to a debate on when compensation became inducement and who drew that line.
For instance, Vandana Gupta probably spoke for most patients when she said that they needed to be treated not as “objects” but “subjects”. A survivor of Hodgkin’s lymphoma for close to two decades, she founded V Care Foundation, which offers support services for cancer patients and their relatives. She agrees that “clinical trials is not a bad word” but expressed concerns about the informed consent process and made very valid suggestions.
For instance, why does it have to be 24 pages long? Can’t it be a short summary in layman’s language? She felt that trials have enough safeguards for doctors, the institution but not the patient. She also brought up the debate on who decides if an SAE is related to a trial, a sticky point indeed as the new compensation guidelines have been criticised by industry citing this and other related issues.
Bringing in the investigator perspective, Dr Vyankatesh Shivane, Clinical Research Investigator, Research Health Institute In Diabetes Endocrinology & Metabolism (RHIDEM) felt that while performing clinical research is an art, it has to be done from the heart. Therefore while he stressed the need for new drugs and vaccines to be tested on Indian patients, he also spoke of the need for ethics committees and institutions to monitor the safety of this research and trials.
Dr C S Pramesh, an onco-surgeon with Tata Memorial Centre and an investigator himself, did allow that some medical researchers get into clinical research for the wrong reasons but reiterated that the process had enough stringent checks and balances to weed out these players fairly early in the process. The problem was that the few examples of ‘bad’ medical research has been amplified. One solution he proposed was that he Medical Council of India should introduce training in clinical research during the MBBS course so that young medicos imbibe the right approach from the start.
The consensus was that we need to evolve India specific solutions to these issues. For instance, Dr Arun Nanivadekar, who is involved with many ethics committees in Pune and has had a long innings in the pharma industry, made the point that the true spirit of the informed consent needed to be followed, and not just an adherence as required by law.
To which the moderator of the panel discussion Dr Arun Bhatt, President, Clininvent Research quipped, only half in jest, that there seemed to be more lawyers than doctors involved in clinical research today!
Speaking not just as a sponsor but as a member of the clinical research community, Dr Suresh Menon, Clinical Scientific Officer, Novartis India said that informed consent was the crux of the problem. A robust informed consent process would solve most issues but admitted that was easier said than done. He reiterated the need for India-centric regulations; for instance, a mere signature on the informed consent document was not enough and therefore the need to film the process. He suggest mandatory registering of all sponsors, CROs and investigator sites involved with clinical research and trials, with regular audits of sites.
Some panelists seemed hopeful that policy makers are now willing to hear their concerns and beginning to appreciate the finer nuances of clinical research and trials and in time, will modify the guidelines based on their observations. Till the pendulum swings back to the middle path, for now, it seems to be introspection time for all stakeholders.
