Usha Sharma – Mumbai
In order to bring more transparency in the clinical trial (CT) process in India, the Drug Controller General (India) (DCGI) has recently issued an order asking sponsors to provide details of agreements with investigators/institutions pertaining to payments for conducting CL.
The Good Clinical Practice (GCP) guidelines provide that the sponsor should enter into a formal and legal agreement/contract with investigator(s)/institution(s) before the start of the trial on various terms of the trial. The agreement should also define the relationship between the investigator and sponsor in matters such as financial support, fees, honorarium, payments in kind etc.
Dr Arun Bhatt, President, Clininvent Research said, “We do not foresee any issues related to the order but our only worry is the time required for such approval. The submission process for CL-related agreement details require three to four months and with the new order, it may get further extended to another one or two months.”
According to an ISCR spokesperson, “While many of the recent initiatives from the Ministry of Health are a step forward in this direction, we are concerned with the haste with which some initiatives are being introduced without a consultative process that involves discussion with and feedback from various stakeholders involved in the clinical research process.”
Bhatt further said, “All investigators do not get approved by the DCGI. Practically speaking, we cannot submit the agreement copies before a CL begins and this becomes another practical issue which will delay the approval process.”
According to the order, it has been decided that the information with respect to the payments made by the sponsor to the investigator for the conduct CT should be made available. Dr Shreekant Sapatnekar, CEO, Savishree Consultants points out, “Principal investigator is conducting an ethical clinical trial and he/she must be compensated. This income will form a part of his/her gross income. If this information can be shared with the income tax authority (in an annual return format), why not with other government authorities. I feel that transparency and accountability can not be given a go bye.”
ISCR points out, “More importantly, we fail to understand the reason for requesting this information at the time of submission of a clinical trial application since the final selection of sites for a trial study is contingent upon the approval granted by the DCGI and post a review by the NDAC. It would therefore be premature for sponsors/CROs to enter into final agreements with investigators/sites prior to the grant of approval by the DCGI. Not only would the pre application process be time consuming and impractical, but if a site were not approved by the regulator, there would be additional time and investment in making these contracts null and void which could cause misunderstanding with Investigators/sites.”