title: Are development times for pharmaceuticals increasing or decreasing?
abstract: This study examines trends in drug development times. Longer clinical trial times have been described as one factor leading to higher drug prices. Previous reports on development times have been based on proprietary data. We examined trends in development times for 168 drugs with data collected from publicly available sources. The median clinical trial and regulatory review periods for drugs approved between 1992 and 2002 were 5.1 and 1.2 years, respectively. Clinical trial periods have not increased during this time frame, and regulatory review periods have decreased. Therefore, it is unlikely that longer clinical trial times are contributing to rising prescription drug prices.
authors.affiliation: Mount Sinai School of Medicine, New York City, USA. Salomeh.Keyhani@mountsinai.org
authors.forename: Salomeh
authors.initials: S
authors.lastname: Keyhani
authors.forename: Marie
authors.initials: M
authors.lastname: Diener-West
authors.forename: Neil
authors.initials: N
authors.lastname: Powe
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000639:trends*; D017277:Drug Approval / Q000191:economics*; D016527:Drug Costs; D004341:Drug Evaluation / Q000191:economics / Q000639:trends*; D011307:Drug Prescriptions / Q000191:economics; D006801:Humans; D013997:Time Factors; D014481:United States