Health Affairs

Health Affairs, 25, no. 2 (2006): 461-468 doi: 10.1377/hlthaff.25.2.461 © 2006 by Project HOPE	New Online   Getting Health Reform Done   After the State of the Union   Incremental Reform   E-Health in Developing World   Most-Read Articles in 2009

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Health Tracking

TRENDS

Are Development Times For Pharmaceuticals Increasing Or Decreasing?

Salomeh Keyhani, Marie Diener-West and Neil Powe

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.

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