Could Simplified Clinical Trials Lead to More Diversity?

During comments made at the 2023 Innovations in Regulatory Science Summit, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni called for simplifying clinical trials.

The FDA has been focused on increasing the diversity in clinical trials for nearly a year now, following April 2022 draft guidance that asked for sponsors to develop a Race and Ethnicity Diversity Plan to ensure trial participants from underrepresented racial and ethnic populations in the United States are included in clinical trials. Cavazzoni noted that while guidance is one way to increase diversity, the FDA can also work to increase diversity by “encouraging the use of innovative trial designs.”

Cavazzoni noted that the FDA and other agencies “have a role in striving to simplify clinical trials and getting to a point where clinical trials protocol and execution are fit-for-purpose for the questions that are being asked and not complicated by a whole bunch of things that may be intellectually interesting but do not necessarily add to what the trial is really supposed to answer.”

Cavazzoni further noted that when the FDA is deliberately working with researchers and companies on trial designs, statistical analysis planning, and Quality by Design approaches, “we need to stroke the right balance when it comes to the collection of information and the need to make clinical trials feasible.” She went on to say “appropriate simplification of clinical trials’ protocols and execution is very much on the to-do list.”

Cavazzoni also mentioned that when looking at the historical data of Alzheimer’s disease trials, they have included low single digit numbers of non-white patients, but the FDA is starting to see this change. They have started to see that some of the more recent studies are “finally reflecting a more diverse population.”

She went on to note the importance of technology and that the FDA has been advancing the use of digital health technologies, citing the agency’s grants for a study focused on developing a telemedicine version of the ALS Functional Rating Scale to measure function in patients with ALS.

Cavazzoni also touched upon striking a balance “against making development programs impossible to execute” and that there are some very loud voices in industry that have expressed concerns about making sure changes are done in a “sensible and realistic away.”

For a recording of the summit, including the panel on increasing clinical trial diversity, click here.