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Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study.

Sanhita Sengupta1, Ives Ntambwe1, Katherine Tan2

  • 1Bristol Myers Squibb, New York, New York, USA.

Clinical Pharmacology and Therapeutics
|January 6, 2023
PubMed
Summary
This summary is machine-generated.

This study shows that a hybrid control arm design using real-world data (RWD) can effectively emulate a completed randomized controlled trial (RCT) for non-small cell lung cancer, potentially reducing study duration.

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Area of Science:

  • Clinical Trials
  • Real-World Data Analysis
  • Oncology

Background:

  • Randomized controlled trials (RCTs) are the gold standard for evaluating cancer treatments.
  • Real-world data (RWD) offers a valuable supplementary data source for clinical research.
  • Hybrid control arm designs combine RCT and RWD to potentially improve trial efficiency.

Purpose of the Study:

  • To assess the feasibility of a hybrid control arm design using RWD to emulate a completed phase III RCT.
  • To evaluate the performance of frequentist statistical borrowing methods in this hybrid design.
  • To determine the potential reduction in study duration compared to a traditional RCT.

Main Methods:

  • Retrospective analysis of a completed phase III RCT (CheckMate-057) in advanced non-small cell lung cancer.
  • Emulation of a trial with an experimental arm from the RCT and a hybrid control arm using both RCT and RWD control cohorts.
  • Application of three frequentist statistical borrowing methods: two-step Cox model, fixed Cox model, and propensity score-integrated composite likelihood.
  • Evaluation of experimental treatment effect using hazard ratios (HRs) and 95% confidence intervals (CIs), and assessment of study duration reduction.

Main Results:

  • All three statistical borrowing methods yielded comparable experimental treatment effects to the original RCT.
  • Hazard ratios (HRs) were consistently estimated across methods (0.73-0.74).
  • Study duration could be reduced by 99-115 days by borrowing 30-38 events.

Conclusions:

  • Emulating an RCT using a hybrid control arm design with RWD and frequentist borrowing methods is feasible.
  • The choice of a suitable, fit-for-purpose RWD cohort is crucial for minimizing bias.
  • Hybrid designs show promise for increasing the efficiency of clinical trials in oncology.