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Development of an External Control Arm Using Electronic Health Record-Based Real-World Data to Evaluate the Efficacy

Ji-Young Jeon1,2, Min-Ji Kim1,3, Yong-Jin Im1,2

  • 1Center for Clinical Pharmacology, Jeonbuk National University Hospital, Jeonju, Korea.

Clinical Pharmacology and Therapeutics
|March 2, 2023
PubMed

Insights

Building an external control arm (ECA) using real-world data (RWD) from COVID-19 patients showed no significant difference in recovery time compared to traditional randomized controlled trials (RCTs). This approach can accelerate new treatment development during pandemics.

Area of Science:

  • Clinical Trials
  • Real-World Evidence
  • Health Informatics

Background:

  • Developing treatments for severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) is crucial for public health.
  • Externally controlled trials (ECTs) offer a potential method to expedite drug development timelines.
  • Evaluating the feasibility of ECTs using real-world data (RWD) is essential for regulatory decision-making.

Purpose of the Study:

  • To assess the feasibility of using an external control arm (ECA) derived from RWD for coronavirus disease 19 (COVID-19) treatment trials.
  • To compare an ECA built from electronic health record (EHR) data against the control arm of a randomized controlled trial (RCT).

Main Methods:

  • An ECA was constructed using RWD from an EHR-based COVID-19 cohort.
  • The ECA served as the control for previously conducted Adaptive COVID-19 Treatment Trials (ACTT).
  • Propensity score matching was employed to balance covariates (age, sex, baseline clinical status) between the ECA and RCT control groups.

Main Results:

  • No statistically significant differences were observed in the time to recovery between the ECAs and the control arms of the ACTT trials.
  • The baseline clinical status ordinal score was the most influential covariate in constructing the ECA.
  • Propensity score matching successfully balanced key patient characteristics.

Conclusions:

  • External control arms built from EHR-derived RWD are a viable substitute for traditional RCT control arms in COVID-19 treatment studies.
  • This methodology can significantly accelerate the development of novel therapeutics, particularly during public health emergencies.
  • ECTs using RWD hold promise for more efficient drug development and regulatory review processes.

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