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October 10, 2025Open Access

Selection Bias in Hybrid Randomized Controlled Trials using External Controls: A Simulation Study

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Authors

HCHan Chang ChiamFKFranz KönigMPMartin Posch

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Overview

Simulation study quantifies selection bias in hybrid RCTs with external controls, suggesting strategies for mitigation.

Key Points

  • Selection bias was quantified in hybrid RCTs using external control data, indicating significant implications for validity.
  • Results showed that biases stemmed from outcome-dependent selection of historical controls, influencing sample size and design.
  • Methods employed included simulation techniques to assess biases under various scenarios, ensuring robust analysis.
  • Findings highlight the critical need for careful prespecification of external control selection to maintain study integrity.

Cite This Study

Chiam et al. (2025) studied this question.

synapsesocial.com/papers/68e997abe14057276da7f250https://doi.org/10.48550/arxiv.2510.04829
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