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Abstract:
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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.
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