The Indian Society for Clinical Research (ISCR) has expressed concern over the Drugs Control General of India (DCGI)'s intention in seeking information from clinical trial sponsors and CROs regarding the financial support, fees and payments in kind offered to the investigators while making a submission for a clinical trial application.

In his order dated 30.8.13, the DCGI had asked the clinical trial sponsors to furnish details of the contracts with the investigators with regard to the financial support, fees and payments in kind, while making the applications for trial permissions.

Expressing concern over the haste with which some initiatives are being introduced by the DCGI without a consultative process that involves discussion with and feedback from various stakeholders involved in the clinical research process, an ISCR spokesperson said that the intent of the regulatory authorities to request this information from sponsors/ CROs while making a submission for a clinical trial application is not clear.

GCP guidelines already prescribe that a sponsor/CRO must enter into a formal and legal agreement with the investigator/institution before the start of a trial. Details of agreements between sponsors/CROs and investigators/sites, including the financial support, fees, honorarium, payments, research grants, etc., are maintained and available at the clinical research site. Should the regulatory authorities want to ascertain these details, they can always do so in the course of a site inspection, the spokesperson said.

The spokesperson further said, “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.”

Therefore in ISCR’s view, the two main concerns we have with the DCGI's recent order are that a consultative process was not followed in introducing the order and the logistical and practical challenges of conforming with such an order have not been taken into account, the spokesperson further said and added that if there is a need for regulatory authorities to seek this information, this could be provided for post approval and before a study is actually initiated at a particular site as is done for Ethics Committee approvals.