Trends: Are development times for pharmaceuticals increasing or decreasing?

Salomon Keyhani, Marie Diener-West, Neil Powe

Research output: Contribution to journalReview article

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.

Original languageEnglish (US)
Pages (from-to)461-468
Number of pages8
JournalHealth Affairs
Volume25
Issue number2
DOIs
StatePublished - Mar 1 2006

ASJC Scopus subject areas

  • Health Policy

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