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doi: 10.1016/s0015-6264(67)83060-8 96 RicelliA.BaruzziF.SolfrizzoM.MoreaM.FanizziF

demographics levels of 13.6% and 18.9% respectively Each stakeholder group has made significant commitments to support and enable clinical trials, and increasing clarity around what needs to be done and examples of progress and success cases provide important building blocks for future progress Success cases from sites that consistently over-recruit study participants relative to their demographics highlight some of the critical factors to engage under-represented populations in the clinical trial process Other Findings Building an understanding of potential safety and efficacy variability across patient sub-groups requires comprehensive focus across the entire clinical development program of a new therapy from target discovery and exploratory trials through confirmational clinical trials to study in post-approval real world data collection A key clinical development program goal should be to build a solid evidence base over time that increases confidence that if any clinically meaningful differences in safety and efficacy between sub-population responses do exist, they are identified and explored as early as possible and are factored into each stage of clinical trial planning Analysis of ClinicalTrials.gov data shows that relative racial and ethnic inclusion on clinical trials has remained steady or has decreased slightly over the past decade for interventional Phase II and III trials with industry involvement and at least one U.S