Correlates of time to approval and other clinical development periods. Issue 9 (September 2019)

• Record Type: Journal Article
• Authors: Breder, Christopher D.; VanHeusen, Margaret; Chang, Lin-Chau
• Is Part Of: Drug discovery today. Volume 24:Issue 9(2019)
• Page Start: 1871
• Page End: 1876
• Publication Date: 2019-09
• Subjects: Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2019.05.027
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: A comprehensive evaluation of duration of clinical development periods for over 800 NDAs was performed. Time cost or benefit is demonstrated for non-approval actions and Priority Review designation. Significant, large effects are observed between the factor of Applicant and most intervals' duration. A significant interaction of Applicant and their NDA order suggests Experience is related to study efficiency. Other notable associations with interval duration include ATC2 class and First Review Cycle Outcome. Abstract : The drug development cycle is classically divided into a clinical phase and review phase, with the clinical phase typically being further partitioned based on the planning and conduct of adequate and well controlled trials. Factors affecting the duration of the development intervals have not previously been systematically investigated. Here, we analyze a large population ( N = 825) of New Drug Applications (NDAs) approved between 2008 and 2017 to characterize the typical duration of these intervals and the development factors associated with their duration. These data and analyses will help those involved in pharmaceutical development by enabling data-driven planning and by providing insight into the effect of certain factors on the duration of drug development programs.