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Activity Number:
168 - Section on Teaching of Statistics in the Health Sciences P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Monday, August 8, 2022 : 12:30 PM to 1:50 PM
Sponsor: Section on Teaching of Statistics in the Health Sciences
Abstract #322324
Title: The Statistician as an Investigator and Educator, Not Just a Power Calculator, on Clinical Research Protocols
Author(s): Alexia Iasonos*
Companies: Memorial Sloan Kettering Cancer Center
Keywords: oncology; clinical trials; early phase trials; sample size estimation; collaboration; health sciences

Recent early phase clinical trials and trials of targeted or immune based therapy in oncology involve innovative clinical trial designs that aim to address multiple scientific objectives simultaneously and efficiently. These designs do not have straightforward power calculations for a sample size justification, and an ideal design must align with the numerous scientific questions being asked. It is imperative that statisticians involved in such protocols play a fundamental role in the concept and design of these trials as part of a larger multidisciplinary protocol team. As the clinical field evolves, so do the design options and thus the statisticians’ role has evolved from a collaborator to a collaborator and educator who guides the clinical team on the pros and cons and the clinical implications of various designs. In this discussion, we will cover the challenges, opportunities, and responsibilities the statisticians have as collaborators and educators when working with clinicians, which might include trainees, in protocol development while aiming to address the scientific objectives and simultaneously adhere to ethical principles for medical research in human subjects.

Authors who are presenting talks have a * after their name.

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