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March 1, 1985Journal of the American Statistical Association639 citations

The Design and Analysis of Sequential Clinical Trials.

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DHDavid HarringtonJWJohn Whitehead

Key Points

  • Provide a comprehensive methodological framework for the design, continuous monitoring, and formal statistical analysis of sequential clinical trials.
  • Details statistical methodologies for patient allocation, treatment difference estimation, and the construction of stopping boundaries.
  • Outlines techniques for incorporating prognostic covariates and extending sequential frameworks to comparisons involving more than two treatments.
  • Establishes boundary-based decision rules that permit repeated interim analyses while maintaining rigorous control over overall type I error rates.
  • Provides practical analytical procedures to facilitate early trial termination for either clear efficacy or demonstrated futility without statistical bias.

Abstract

Clinical Trials. Allocating Patients to Treatments. Measurement of Treatment Difference. The Design of a Sequential Trial Using the Boundaries Approach. The Analysis of a Sequential Trial. Alternative Approaches to the Design and Analysis of Sequential Clinical Trials. Prognostic Factors. The Comparison of More than Two Treatments. Implementation of Sequential Methods: Some Examples. References. Appendix. Index.

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Cite This Study

Harrington et al. (1985) studied this question.

synapsesocial.com/papers/6a091cc9266340834eb61bf2https://doi.org/10.2307/2288093
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