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August 30, 2026Clinical TrialsOpen Access

A practical application for the efficient use of historical data in randomized controlled design using systematic review data

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Authors

TSTim J. SchoutenAGAndrea GabrioJCJochen W. L. Cals

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Overview

Meta-analytic modeling demonstrates that data-derived heterogeneity estimates increase historical control information borrowing in diabetes trials, indicating a practical route to reduce sample sizes.

Key Points

  • To assess the feasibility of constructing historical controls using Bayesian meta-analytic predictive priors derived from systematic review data in type 2 diabetes mellitus.
  • Extracted baseline and end point glycated hemoglobin values from 25 randomized trials comprising 36 comparisons of metformin.
  • Constructed meta-analytic predictive priors using the RBesT package and quantified data contribution using the effective sample size metric.
  • Evaluated a default conservative between-trial heterogeneity prior (τ = 0.5) against empirically derived τ values from the metafor package, with sensitivity analyses stratified by follow-up duration and publication year.
  • Initial models with high between-trial heterogeneity (τ = 0.55–0.85) yielded low effective sample size values of 1–4, showing negligible information borrowing from historical trial data.
  • Excluding four outlier studies lowered the data-derived τ to 0.0935 and increased the effective sample size from 18 to 52, while preserving stable treatment effect estimates of −1.34% to −1.36% glycated hemoglobin.

Cite This Study

Schouten et al. (2026) studied this question.

synapsesocial.com/papers/6a93f1726c1a8fb52e79e563https://doi.org/10.1177/17407745261467982
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  4. 4Selection Bias in Hybrid Randomized Controlled Trials using External Controls: A Simulation Study2025
  5. 5Sample Size Re‐Estimation in Blinded Hybrid‐Control Design Using Inverse Probability Weighting2026