Clinical Trial Diversity: We Must ‘Turn This Moment Into A Movement’
Pfizer and Genentech execs describe steps they’ve taken to increase diversity in clinical trials from moving trial sites into new neighborhoods to modifying protocols and holding others accountable for diversity.
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Although differences in how sponsors have publicly disclosed demographic data for their enrolled trials make cross-study comparisons difficult, in general trial enrollment of Black and Hispanic participants has ranged from 10%-19% and 11%-45%, respectively, with one-quarter to one-third of study subjects falling into older age groups.
Industry principles for enhancing diversity in clinical trials call for use of digital data collection tools and flexible scheduling of study site visits to reduce barriers to enrollment, as well as greater involvement of under-represented communities in the trial design planning process and recruitment of investigators with diverse ethnic and racial backrounds.
A composite endpoint conceals Actemra’s lack of mortality benefit – while life-saving dexamethasone gets EMA endorsement.