Plagued by a lack of trust, clinical research organisations are looking at remedial action from within the industry. An ombudsman-like advisory board is being mooted by clinical and contract research organisations to bring transparency into how they work.
Every time a clinical trial allegedly goes awry, there is a backlash on medicines being tested on humans. Subsequently though, there is little visibility on investigations into the incident, who is at fault or not, and the remedial action, say CRO representatives.
To build bridges of trust, the Association of Contract Research Organisations (ACRO) has mooted an ombudsman-like advisory board, with reputed representatives not from the industry, but those familiar with the science involved, in terms of pharmaco-vigilance toxicology etc, says ACRO Chairman Mr Apurva Shah, who also wears the hat of Group Managing Director, Veeda Clinical Research.
Testing levels
Clinical trials and research involve several levels of testing medicines on human patients or volunteers. The trial could involve breakthrough drugs being exposed to humans for the first time, or it could be a bio-equivalence study to confirm the safety of a known medicine, whose safety profile has been established in studies overseas.
The plan is for a five-member advisory committee “similar to an ombudsman”, expected to be set up in about three months, says Mr Ashish K. Dasgupta, ACRO Vice-Chairman, also Managing Director of Anregen Consulting. ACRO is under the Confederation of Indian Industry (CII) and represents a large section of CROs in the country, he adds.
Echoing similar sentiments, at the other end of the clinical trial spectrum and representing pharma companies as well, is the Indian Society for Clinical Research (ISCR). It is important to have a self-regulating mechanism that will make an independent, free and fair assessment of adverse incidents, agrees Dr Krathish Bopanna, ISCR President and Director – Semler Research.
Scrutiny
Despite allegations of death during clinical trials or lack of informed consent – where volunteers claim they are not aware of what they signed up for – Mr Shah maintains that large CROs are under constant regulatory scrutiny.
Inspected about two to three times a year by the United States Food and Drug Administration, for instance, Indian CROs fare well, says Mr Shah, comparing it to the red-marks that appear at times on the pharma industry's report card with the USFDA.
Sometimes, there are simultaneous checks at different clinical trial sites and with no prior intimation, he points out.
There is intense documentation required, traceability audits are done to trace back the chain of events in trials, he adds. And trials need to be done locally, to bring in medicines tailored for the local population, representatives add.
The clinical research industry already suffers from not scaling the heady $1.5 billion peak it was projected to by 2010. Clinical research in the country is now worth about $300 million, Dr Bopanna says. But, if the entire gambit, including data management and pharmaco-vigilence etc were added up, the sector would gross $1 billion, he adds.