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External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources.

Aparna C Swaminathan1,2, Laurie D Snyder1,2, Hwanhee Hong2,3

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|June 29, 2023
PubMed
Summary

External controls (ECs) from historical clinical trials enhance idiopathic pulmonary fibrosis (IPF) trial efficiency. However, real-world data sources like patient registries or electronic health records (EHRs) do not yield comparable results for IPF studies.

Keywords:
BMS-986020clinical trial designinterstitial lung diseasesynthetic control arms

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Area of Science:

  • Pulmonology and Clinical Trial Methodology

Background:

  • Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease requiring novel therapeutic strategies.
  • External controls (ECs) offer potential to improve the efficiency of clinical trials in IPF.
  • The direct comparability of ECs derived from various data sources against concurrent controls remains undetermined.

Purpose of the Study:

  • To develop fit-for-purpose external controls (ECs) for IPF using historical randomized clinical trial (RCT), Pulmonary Fibrosis Foundation Patient Registry, and electronic health record (EHR) data.
  • To evaluate the endpoint comparability of these ECs against the concurrent control arm in a phase II RCT of BMS-986020.

Main Methods:

  • Data curation from historical RCTs, a patient registry, and EHRs to create IPF ECs.
  • Comparison of the rate of change in forced vital capacity (FVC) from baseline to 26 weeks between the BMS-986020 treatment arm, the BMS-placebo arm, and the developed ECs.
  • Application of mixed-effects models with inverse probability weighting for comparative analysis.

Main Results:

  • The rate of FVC decline in the BMS-placebo arm was -130.09 ml at 26 weeks, consistent with the original RCT.
  • External controls derived from historical RCT placebo arms demonstrated treatment effect point estimates within the 95% confidence interval of the original RCT.
  • External controls from the Pulmonary Fibrosis Foundation Patient Registry and EHR data showed slower FVC decline, yielding treatment effect estimates outside the original RCT's 95% confidence interval.

Conclusions:

  • External controls generated from historical RCT placebo arms provide comparable primary treatment effects to those observed in the original clinical trial for IPF.
  • External controls derived from real-world data sources (registry or EHR) do not yield comparable primary treatment effects.
  • ECs from historical RCTs may serve as a valuable supplement for future IPF RCTs, while real-world data ECs require further methodological refinement for direct comparability.