In a move that is likely to leave many doctors squirming particularly from the private sector, the Union Health Ministry has decided to restrict the medical practitioners from conducting more than three clinical trials at a time in the country.
There have been allegations that private doctors have been taking up clinical trials in a large number as profitable business ventures ignoring science and rights of patients.
The proposed step to put a cap on number of clinical trials come close on the heels of the Drug Controller General of India (DCGI)’s move to make it mandatory for pharma companies and sponsors to disclose the financial support or payments made to the clinical investigators or medical practitioners for conducting clinical experiments.
A senior officer in the Ministry said that the cap on number of clinical trial has been one of the major recommendations by the Ranjit Roy Chaudhary Expert Committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs which submitted its report recently.
He said that “number of clinical trials an Investigator can undertake should be commensurate with the nature of the trial, facility available with the Investigator etc. However, under no circumstances the number of trials should be more than three at a time.”
The official referred to a study by authors of the PloS Medicine, Vanderbilt University bioethicist Jill A Fisher and University of North Carolina at Chapel Hill doctoral student Corey A Kalbaugh wherein they conducted interviews and at-work observations of 63 physicians and other research staff at 25 private sector research organisations in the southwestern United States.
They found that money was the primary reason private sector physicians become contract researchers. The study also found that physicians view their role in the clinical trials as having more to do with business than with science. As a result, the physicians have also adopted industry’s approach to research ethics, the study said, as per the official.
He further said that the Ministry has also agreed with the panel’s recommendation to conduct clinical trials at accredited sites by accredited Investigator with the oversight of accredited Ethics Committees (ECs). “This is a long-term measure. In the meantime, Quality Council of
India will be considered for creating a system for accreditation of Investigators, ethics committee and clinical trial sites.”