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43.3 2020 Year in Review: Progress in developing clinical endpoints necessary to support drug approvals

Stephen Harrison summarizes a year of progress in improving the tests and analyses used to derive clinical endpoints necessary to initial drug approvals


Despite reports earlier in the year, Stephen Harrison discusses the “aggressive, conscientious effort” an array of stakeholders is making to improve on the clinical endpoints that shape the decision to approve a Fatty Liver Disease drug before it has demonstrated positive outcomes for patients and the healthcare system. Three keys: (1) more rigorous human review of biopsy slides, (2) an eventual shift to incorporate Artificial Intelligence and, someday, (3) use of AI and non-invasive tests as a complete plan for developing these clinincal endpoints.

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