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Building the Business Case for Digital Endpoints

Four years ago, we launched the Library of Digital Endpoints, and since then, the number of sponsors actively collecting digital endpoints in clinical trials has increased more than tenfold. Despite this, there’s still some hesitancy in scaling digital endpoints broadly across the clinical trials enterprise.

This project will establish effective measures to monitor and benchmark the value and maturity of digital endpoints across the field, including quantitative and qualitative considerations around their net financial value, impact on participant, investigator, and site burden, effects on clinical trial accessibility, and value in downstream reimbursement decision making, and develop a template business case to support the development, adoption, and scale of digital endpoints.

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