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Related Experiment Videos

ICH E9 guideline 'Statistical principles for clinical trials': a case study.

Alan Phillips1, Vincent Haudiquet

  • 1Wyeth Research, 500 Arcola Road, Collegeville, PA 19426, USA. phillia@wyeth.com

Statistics in Medicine
|December 18, 2002
PubMed
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This paper reviews challenges in regulatory submissions by comparing them to the International Conference on Harmonization (ICH) E9 guideline principles for clinical trials. It offers recommendations for future drug development programs to ensure dossier approvability.

Area of Science:

  • Regulatory Science
  • Clinical Trial Methodology
  • Pharmaceutical Development

Background:

  • The International Conference on Harmonization (ICH) E9 guideline on Statistical Principles for Clinical Trials was adopted in 1998.
  • This guideline is operational in Europe, the USA, and Japan.
  • Clinical development programs initiated in the mid-1990s may not have fully incorporated these principles.

Purpose of the Study:

  • To align practical challenges from a recent regulatory submission with ICH E9 guideline principles.
  • To review statistical principles from the ICH E9 guideline that were not fully addressed during early clinical development.
  • To provide recommendations for avoiding similar issues in ongoing and future clinical development programs.

Main Methods:

  • Review of a specific regulatory submission's encountered problems.

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  • Analysis of these problems against the ICH E9 guideline's statistical principles.
  • Discussion of the impact of statistical issues on dossier approvability.

    • Main Results:

    • Identification of specific statistical principles from ICH E9 that posed challenges.
    • Assessment of how these statistical issues affected the regulatory submission's approvability.
    • Documentation of lessons learned from the submission process.

    Conclusions:

    • Adherence to ICH E9 statistical principles is crucial for successful regulatory submissions.
    • Early and comprehensive integration of ICH E9 guidelines mitigates risks in clinical development.
    • Proactive management of statistical issues enhances the likelihood of drug approval.