For the first time, the Drug Controller General of India (DCGI) has made it mandatory for pharma companies and sponsors to disclose the financial support or payments made to the clinical investigators for conducting clinical trials.
The much-awaited move by the top drug regulator, which is under fire from various quarters including Supreme Court and a Parliamentary panel for allowing patients to be used as ‘guinea pigs’ in the conduct of drug trials, aims to make the process more transparent. It would minimise bias as well as keep a tab if there is any conflict of interest between the sponsor and the clinical investigator, said a senior health official.
He explained, “The DCGI hopes that review of financial disclosure information will alert its staff to financial interests and arrangements that could lead bias in covered clinical studies. “The financial disclosure process will also provide the DCGI with information regarding whether and to what extent the sponsors have taken steps to minimise the risk of bias.”
Till recently, the rules were silent on the details of the financial aspect. It just made it mandatory for the sponsor to enter into a formal and legal agreement/contract with the investigators before the start of the trial on various terms of the trial and define the relationship between the investigator nd sponsor in matters such as finacials upport, fees, honorarium etc.
There had been complaints that in return of huge profits the clinical investigators who primarly are either doctors or researchers favoured the pharma companies ignoring the rights of the patients during the clinical trials.
However, making the rules more stringent to protect the rights of the patients, the DCGI order issued on August 30, mandates “the sponsor or his representative while making an application to the DCGI for undertaking clinical trial to furnish the details of the contract entered by the sponsors with the investigators/institutions with regard to financial support, fees, payments in kind to be paid to the investigator”.
lately, the DCGI has also made it mandatory for investigators and sponsors to address issues of serious adverse events such as death of subjects involved in trials and fixing a formula for grant of adequate compensation in such cases. The new rules, which came into force this year, for the first time, propose a formula for minimum compensation to be paid by the sponsoring firm in case of serious adverse events such as death or injury of the trial participant.