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This study reviews methods to reduce bias in adaptive clinical trial estimates. It addresses the need for accurate treatment effect estimations in trials with design modifications.

Keywords:
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Area of Science:

  • Biostatistics
  • Clinical Trial Design

Background:

  • FDA guidance emphasizes unbiased treatment effect estimation in adaptive trials.
  • Conventional estimates in adaptive designs can be biased due to trial modifications.
  • Bias in estimation has received less attention than type I error and power.

Approach:

  • This article provides a comprehensive review of methods to remove or reduce bias in point estimation for adaptive designs.
  • Methods are classified into unbiased and bias-reduced estimation categories.
  • Estimators are further classified by adaptive design type.

Key Points:

  • Focuses on bias in point estimation for adaptive clinical trials.
  • Reviews methods for unbiased and bias-reduced estimation.
  • Highlights software, code, and identifies literature gaps.

Conclusions:

  • This review is the first part of a two-part series on bias in adaptive trial estimation.
  • Part I focuses on reviewing existing methods for bias reduction.
  • Part II will cover practical implementation and guidelines for statisticians.