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Area of Science:

  • Biostatistics
  • Clinical Trial Methodology

Background:

  • The International Council for Harmonisation (ICH) document
  • Statistical Principles for Clinical Trials
  • provides foundational guidance for clinical trial design and analysis.

Purpose of the Study:

  • To interpret the proposed addendum to the ICH
  • Statistical Principles for Clinical Trials
  • document regarding estimands.

Main Methods:

  • Analysis of the proposed estimand framework within the ICH addendum.
  • Evaluation of whether the framework necessitates adapting existing statistical methods or developing new ones.

Main Results:

  • The addendum introduces a new framework for discussing estimands.
  • This framework requires both the integration of current statistical methods and the development of novel approaches.
  • Some estimands present challenges for estimation, while others are readily and reliably estimated.

Conclusions:

  • The ICH addendum on estimands offers a dual interpretation: adaptation and innovation.
  • While some estimands pose estimation challenges, others can be addressed effectively with existing or modified methods.
  • The framework supports robust estimation for certain desirable estimands.