Draft guidance has been released by the USFDA regarding the ways to enhance the participation of population diversity in clinical trials. Sponsors must consider the USFDA recommendations while designing and conducting clinical trials in order to eliminate avoidable exclusions and to get effective safety data.
The salient recommendations by the US FDA in the draft guidance includes
➤ Inclusive enrollment practice and broadening of eligibility criteria must be followed by sponsors to include diverse participant population in clinical trials.
➤ Recruitment events can be conducted more often during weekend hours and evening time, which can enhance the active participation of potential participants. Commercial and trusted locations such as beauty salons and houses of worship can be selected for conducting recruitment events in order to get diverse population.
➤ Potential challenges can be shared by patients, which must be included in informed consent.
➤ Financial reimbursement can be offered to the participants.
➤ Study visits frequency can be reduced with the inclusion of various technologies such as secured electronic mail, telephone, mobile technology tools, etc. In this way, real-time data can be received by the investigators without the physical study visit of participants.
➤ An adaptive design can be initiated with less population, if there is a safety concern and can be extended following the safety data.
Comments on this draft guidance can be accepted by the USFDA till 06 August 2019.
Mr Vinod Arora, Principal Advisor, IGMPI
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