India’s Supreme Court has expressed concern at the conduct of clinical trials asking the government to provide information on the number of trials being conducted, adverse event reports, deaths, compensation to subjects and so on. Call me an optimist but this could be one of the best things to have happened to the sector in recent years.
Why, when the SC has threatened to shut down clinical trials in the country, do I think so? My reasons :
1. It will force the government to share information. For long now, the media has been asking for transparency. Just one instance : even now it is easier to access information on trials happening in India from the US FDA’s website than from the Indian government’s own web registry. But the FDA only lists such trials if they come to its portals for approval. What about the rest? With the Supreme Court providing an ultimatum, the public too should get some answers.
2. It exposes the flaws in the system. Provided information is shared, it will quickly become clear what the current system is capable of and what it clearly isn’t managing to do. For instance, it might be that while the drugs regulator’s office has resources and competence to evaluate applications to perform trials, it has no mechanism to judge independently whether injuries and deaths during trials were trial-related or otherwise.
3. It puts the subject back on the government’s agenda. For some reason, clinical research seems to keep falling off the ministry of health’s radar unless of course, there’s a controversy. It’s taken over a decade of clinical research being conducted in India for the ministry to get down to framing guidelines on compensation for trial-related injury or death. Ethics committees function with little, if any, government oversight. And there’s still a question mark on whether informed consent is truly informed.
4. It gives an opportunity for all sides to be heard impartially. Often, the sponsors of trials and their vendors, the clinical research organisations (CROs), complain that their view is never sought or represented in the media and that they are unfairly painted as the bad guys. They can seek to intervene and so could patient groups.
5. It forces everyone to pull up their socks. It is an open secret that in India clinical research is virtually self-regulated. Even though the US FDA does pop in once in a while – when trials are for drugs or interventions meant for the US – that just isn’t sufficient. The self-regulation is unlikely to change in a hurry because problems of weak oversight cannot be resolved immediately. So in the meantime, a high-profile court case might just force greater rigour.
6. It creates awareness. News whether ‘good’ or ‘bad’ tends to do that.
None of this will happen overnight. Nor could things have gone on in this state forever.