Bioethics International

Representation in clinical trials hasn’t measurably improved in over a decade: bit.ly/4gwFQcB In our latest installment of #ClinicalEquality Sessions, we speak to Jennifer E. Miller, who is changing the game by giving clinical trial sponsors a diversity scorecard. #ClinicalTrials

Our BMJ med study reviews FDA & stakeholder guidance to develop clinical trial #diversity indicators. We then apply the indicators to assess 50 #pharma companies' #clinicaltrial diversity public #policies. We identified 14 recommendations for improving trial diversity in guidance, which we built into a reference standard: (1) enrollment targets that reflect the prevalence of targeted conditions in populations, (2) broad eligibility criteria for trials, (3) diversity in the workforce, (4) identification and remedy of barriers to trial recruitment and retention, (5) incorporation of patient input into trial design, (6) health literacy, (7) multidimensional approaches to diversity, (8) sites with diverse providers and patient populations, (9) data collection after product approval, (10) diverse enrollment in every country where trials are conducted, (11) diverse enrollment should be a focus for all phases of clinical trials, not just later stage or pivotal trials, (12) varied trial design, (13) expanded access, and (14) public reporting of the personal characteristics of participants in trials. We found 48% (24/50) of companies had no #publicpolicy on diversity in clinical trials; among those w policies, content varied widely. Large companies were more likely to have a public policy than non-large (84% v 20%, P<0.001). Large companies most frequently committed to using epi based trial enrollment targets representing the prevalence of indicated conditions in various populations (71%), dealing w barriers to trial recruitment (71%), & improving patient awareness of trial opportunities (67%). Company location was not associated w having a public diversity policy (P=0.17). The average company policy had 5 of the 14 commitments recommended in FDA, IFPMA PhRMA European Medicines Agency & other stakeholder guidance. Our findings show that many pharmaceutical companies do not have public policies on diversity in clinical trials, although policies were more common in large than non-large companies. Policies that were publicly available varied widely and lacked important commitments recommended by stakeholder guidance. These findings suggest that corporate policies can be better leveraged to promote representation and fair inclusion in research, and implementation of FDA and stakeholder guidance. Thx to coauthors Joseph Ross Cary Gross Reshma Ramachandran Jason Schwartz Michael Mensah Sakinah Carter Suttiratana Will Pelletiers

We are grateful to Amrit Ray, M.D., Hastings Center for Bioethics board member, for moderating our access to medicines panel last week w Ipek Özer Stillman Tanisha Carino Tom Lee Steve Pascoe Frank Marra - co hosted w Lauren Rogge Arda Ural, MSc, MBA, PhD of EY

Our study in JAMA finds #clinicaltrialdiversity is not associated w slower enrollment or clinical development times, for oncology pivotal trials + FDA approved products, w/ Joseph Ross JoshWallach Reshma Ramachandran MaryamMooghali + led by @AlissaWong