December 15, 2023
Sonja Wustrack, Managing Director of Integrated Evidence Generation, OM1
I believe increased focus and pressure to ensure diversity and inclusiveness in clinical trials will be a key mechanism to drive multiple areas of important advancements. Improved diversity in trials has been a topic for decades but until fairly recently addressed on a voluntary basis by pharma and device companies. It is understood that a clinical trial should accurately reflect that population affected by the condition being investigated and should match the real-world population for interpretable results across race, ethnicity, gender and geography. Diversity and inclusion should be considered throughout the planning and execution phases of the trial, as participant attrition may affect overall representation. While the medical research needs to accurately reflect the diverse population it aims to serve, patient inclusion has not achieved demographic levels in the United States, and improvement is needed.
In April 2022, draft guidance was published, with the FDA announcing significant changes in how clinical trials are conducted; focused on trial design that supports broad participation and limits unnecessary exclusions, improvements around patient recruitment and minimization of barriers, and application across all trials, including rare disease. Earlier this year, an omnibus spending bill was enacted that requires diversity action plans for the clinical trials used by the FDA with the goal to encourage investigators to develop a strategy for reaching a broad study population on the front end, instead of failing to do so or acting later and increasing an already costly trial process (Public Law 117-328). Furthermore, FDA Commissioner Robert Califf has stated that diversity must be a more prominent priority. Additional updates of the Diversity and Inclusion guidelines are expected to be published by the end of this year, with enforcement targeted to begin in 2024 that will include mandatory aggregate reports of action plans and details of where falling short.
The continued focus on representativeness in research will drive meaningful changes in how we plan and operationalize trials. One area I am eager to see evolve is the utility of leveraging RWD more readily to meet these objectives: from optimized protocol design to targeted patient recruitment efforts in a manner to circumvent burden, to the conduct of active data collection only where needed –– as a supplement only to passive data collection. I believe utilization of RWD to design robust, inclusive protocols, coupled with pragmatic active and passive data collection, will drive more efficient trials that represent more accurately the patient population under investigation, getting medical products to the right patients faster.