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Abstract:
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The role of real-world evidence (RWE) in drug development and healthcare decision-making is rapidly expanding. While the randomized clinical trials (RCT) continue to be the standard for assessing the safety and efficacy of new interventions, clinical trial participation tends to be disproportionate towards males, white and wealthier subjects. Real world data (RWD) can be used to provide a more comprehensive view of the patient populations including racial, socioeconomic and gender diversity, and determine if extrapolations to other subgroups/settings are valid. In this talk we will illustrate some strategies of leveraging RWD for 1) gaining a more comprehensive description of the target populations, 2) exploring the potential use of synthetic control arms, and 3) conducting generalizability and transportability analyses to predict treatment effects in new populations. The proposed methodology will be illustrated with applications relevant to diversity issues.
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