RWE for Diversity in Clinical Data

Most clinical trials struggle to recruit diverse populations. Use of Real World Evidence (RWE) may offer the solution to this problem. Despite active encouragement and a few guidance documents from FDA about the importance of diversity in clinical trial populations, almost all the new products approved by the FDA in the last decade were based on clinical trials with scant representation from non-Caucasians. The RWE on the other hand is a true representation the populations. FDA accepts clinical endpoints and controls based on RWE in randomized clinical trials. FDA also accepts RWE in support of new uses of previously approved products: drugs, biologics and medical devices. By using RWE at least to establish historical controls and rationale for the endpoints used in a randomized Phase 3 or 4 clinical trials, sponsors can evaluate their products in all populations without having to limit recruitment. This month FDA’s new guidance document on diversity in clinical trials suggests that sponsors should relax eligibility criteria, use new technologies and practices to reduce the burden on patients, use expanded access and increase recruitment incentives to encourage participation from diverse populations. The guidance does not directly mention RWE and RWD but it hints of these options. It is important that sponsors of clinical trials create models for use of RWD/RWE in randomized clinical trials and discuss those with FDA. They may find a very friendly FDA willing to support a trial that is innovative and unconventional in its design for recruiting all populations equally.