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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
PubMed

Insights

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.

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