Needed: A renaissance in clinical research
Clinical research in India seems destined to be in the limelight for the wrong reasons. The regulators seem to be making up for lost time, going into overdrive after a PIL was filed in the Supreme Court in January. Since then, new guidances and advisory boards have been announced and debated with typical kneejerk reactions from all sides. The industry thus feels hounded on all fronts: media, patient groups, parliamentarians.
The common refrain from corporate stakeholders seems to be that more regulations and a review of the existing process are welcome but should not slow down approvals. Many appeals have been made to media and NGOs to be ‘more rational, less emotional’ and not behave like ambulance-chasers, a reference to lawyers who hound patients and their relatives to sue just about anybody.
I hope the Express Pharma May 16-31 Special on International Clinical Trials (ICT) Day has achieved a fair balance between the many interested parties. We have tried to feature all stakeholders: sponsors, CROs, thought leaders from the legal and ethics fields as well as doctors who serve as principal investigators on trials.
The only voice we do not have in enough detail, except for one very short comment, is the patient’s voice. I admit to not pushing too hard, because I felt it was an intrusion on the doctor-patient bond and the patient’s privacy. But I remain optimistic that Express Pharma will soon also reflect the experiences and hopes of patients and their relatives participating in clinical trials.
Clinical research in India has many centres of excellence but it also has a dark side. Like the parallel existence of illegal buildings in India’s metros, hastily constructed by unscrupulous builders out to make a quick buck. With no regard for any civic laws, these structures were built with substandard materials literally sprouting overnight. It is no wonder that many of these sandcastles are collapsing today, like the unethical practices coming to light in clinical research as well.
If the earlier decades were about a breakneck growth in the number of clinical trials in India, I hope that in this decade, we focus on quality rather than quantity. I hope we will see a more measured consolidation, tempered by introspection.
We at Express Pharma hope to be part of this process, as the industry re-builds the foundations of clinical research in India, in line with a reinforced regulatory blueprint, with each stakeholder being part of the process.
And as we move towards the formalisation of medical research protocols, lets hope that next year’s ICT Day Special will reflect a true renaissance.
Viveka Roychowdhury
Editor
- Advertisement -
