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Achieving a Win-Win: Designing More Representative Trials Through Strategic Planning

Achieving a Win-Win: Designing More Representative Trials Through Strategic Planning

Pages 12 Pages

Designing representative trials delivers scientific, operational, regulatory, and commercial benefits. By reflecting real-world populations, sponsors capture variability in treatment outcomes and generate more generalizable data. Operationally, demographic insights guide site selection, eligibility, and recruitment, accelerating enrollment. Regulatory value comes from FDA Diversity Action Plans, which demonstrate intentionality and reduce approvability risks. Commercially, inclusive data strengthens product differentiation with payers and prescribers. Strategic planning requires assessing epidemiology, generating distribution estimates, and setting achievable goals. IQVIA leverages proprietary data and cross-functional expertise to help sponsors craft effective Diversity Action Plans.

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