Repurposing historical control clinical trial data to provide safety context
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Updated: Mar 30, 2026

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
Prakash Bhuyan1, Jigar Desai2, Matthew St Louis2
1Pfizer Vaccine Research, 500 Arcola Road, Collegeville, PA 19426, USA.
Abstract:
Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety.
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