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November 1, 2025Pharmaceutical StatisticsOpen Access

Addressing Non‐Exchangeability in Hybrid Control Studies: A Variable Selection Approach

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Authors

ZZZhiwei ZhangJLJialuo LiuPHPeisong Han

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Overview

This analysis reveals a novel variable selection approach improving efficiency in randomized controlled trials with non-exchangeable controls.

Key Points

  • Efficiency improves in hybrid control studies using variable selection methods.
  • Results indicate that incorporating external control data can enhance the efficiency of trials.
  • Variable selection methods, including adaptive lasso, are proposed to tackle non-exchangeability issues.
  • Findings suggest adjustment for bias is crucial in hybrid trial designs to ensure valid outcomes.

Cite This Study

Zhang et al. (2025) studied this question.

synapsesocial.com/papers/69254377c0ce034ddc358caahttps://doi.org/10.1002/pst.70056
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Selection Bias in Hybrid Randomized Controlled Trials using External Controls: A Simulation Study2025
  2. 2Leveraging External Controls in Clinical Trials: Estimands, Estimation, Assumptions2025
  3. 3Robust integration of external control data in randomized trials2024
  4. 4A Frequentist Approach Using Weighted Estimating Equations for Survival Analysis of Randomized Controlled Trial With External Control Arm2026
  5. 5On the two-step hybrid design for augmenting randomized trials using real-world data2025