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August 1, 2026Research Methods in Medicine & Health SciencesOpen Access

Assessing bias in treatment effect estimation for hybrid goldilocks adaptive trials with continuous outcomes

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Authors

YWYang WangGPGregory PondJMJinhui Ma

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Overview

Randomized trial investigates bias in treatment effect from early stopping in hybrid Goldilocks designs using continuous outcomes.

Key Points

  • This study aims to evaluate how early stopping in hybrid Goldilocks trials affects bias in treatment effect estimation.
  • Two-arm trial with continuous outcomes derived from a normal distribution under varying treatment effects.
  • Interim analyses conducted after 100 patients and every additional 50 until 500.
  • Bias assessed through 10,000 simulated trials using a one-sided Wilcoxon–Mann–Whitney test.
  • Early stopping for predicted success occurred in over 79% of trials.
  • Median percentage bias for early-stopped trials ranged from 15-20% for small effects to 5-7% for large effects, peaking at early interim analyses.
  • The hybrid design reduced required sample size by a median of 51% compared to fixed designs.

Cite This Study

Wang et al. (2026) studied this question.

synapsesocial.com/papers/6a6d989ee258b358b3c6c2b6https://doi.org/10.1177/26320843261474840
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