title: Repurposing historical control clinical trial data to provide safety context.
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.
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: PrakashBhuyan@comcast.net.
authors.forename: Prakash
authors.initials: P
authors.lastname: Bhuyan
authors.affiliation: Pfizer Worldwide Research and Development Business Technology, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Jigar
authors.initials: J
authors.lastname: Desai
authors.affiliation: Pfizer Worldwide Research and Development Business Technology, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Matthew St
authors.initials: MS
authors.lastname: Louis
authors.affiliation: Pfizer Global Innovative Pharma, 235 East 42nd Street, New York, NY 10017, USA.
authors.forename: Martin
authors.initials: M
authors.lastname: Carlsson
authors.affiliation: Pfizer Worldwide Research and Development Business Technology, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Bowen
authors.affiliation: Pfizer Worldwide Research and Development Business Technology, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Danielson
authors.affiliation: New York University School of Medicine, 550 1st Ave, New York, NY 10016, USA.
authors.forename: Michael N
authors.initials: MN
authors.lastname: Cantor
mesh_terms: D002986:Clinical Trials as Topic; D016208:Databases, Factual; D065386:Historically Controlled Study; D006801:Humans; D061214:Patient Safety