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Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint
Abdul J Sankoh1, Ralph B D'Agostino, Mohammad F Huque
1Global Biostatistics, Aventis Pharmaceuticals, P. O. Box 6890, 200 Crossing Boulevard, BX2-300E, Bridgewater, NJ 08807, U.S.A. abdul.sankoh@aventis.com
Statistics in Medicine
|October 1, 2003
Summary
Designing clinical trials often requires selecting a single primary endpoint. This paper explores practical strategies for choosing and analyzing efficacy outcomes in trials with multiple endpoints.
Area of Science:
- Clinical Trials
- Biostatistics
- Drug Development
Background:
- Selecting a single primary endpoint is ideal for clinical trial design and analysis.
- This ideal is often unachievable due to disease complexity or trial constraints.
Purpose of the Study:
- To examine practical decision-making for selecting efficacy outcome measures in clinical trials.
- To address scenarios involving inherent multiplicity components in clinical trial endpoints.
Main Methods:
- Review of clinical decision-making scenarios.
- Analysis of efficacy outcome measures in the context of multiplicity.
Main Results:
- Identification of practical approaches for endpoint selection.
- Strategies for analyzing data with multiple efficacy outcomes.
Conclusions:
- Effective selection and analysis of multiple endpoints are crucial for clinical trials.
- Practical strategies can guide decision-making in complex trial designs.