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Activity Number: 468 - Statistical Challenges and Novel Methodologies for Analyzing Health Outcomes
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2022 : 2:00 PM to 3:50 PM
Sponsor: Section on Nonparametric Statistics
Abstract #323333
Title: Considerations for Primary and Secondary Health Outcomes in Clinical Trials: From Design to Analysis
Author(s): Howard D Sesso*
Companies: Brigham and Women's Hospital
Keywords: clinical trials; outcomes; design; cardiovascular disease; analysis

The appropriate selection of primary and secondary health outcomes, including both intermediate mechanistic markers and clinical outcomes, is critical to the success of randomized trials upon which clinical and public health recommendations are generated. Many considerations – and complications – factor into the selection of primary and secondary health outcomes for clinical trials beyond its scientific justifications. Continuous (e.g. blood pressure) and clinical (e.g. cardiovascular disease) outcomes rely upon appropriate eligibility criteria, reliable and valid assessments, assumptions of effect sizes and event rates, optimal compliance, and maximal patient retention. Pre-specified trial analyses of primary, secondary, and even post hoc outcomes do not always consider multiple comparisons. All of these considerations surrounding the selected outcomes greatly impact the analysis and interpretation of clinical trials. We will examine the impact of primary and secondary health outcome selection in the context of the design, conduct, and analyses of different randomized clinical trials investigating mechanistic, biomarker, and clinical outcomes.

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

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