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A decade of the Fast Track programme

Nature Reviews Drug Discovery volume 7, pages 885–886 (2008)Cite this article

Other than tallies, the FDA does not provide information about Fast Track designated investigational candidates. However, sponsors often do. The Tufts Center for the Study of Drug Development (CSDD) has collected data on these candidates since 1998. The data set now comprises 344 therapeutic, vaccine and diagnostic agents that between them have been granted nearly 400 designations, representing approximately 70% of the Fast Track designations granted by the FDA between January 1998 and June 2008.

Data for 301 therapeutic candidates granted designations between 1998 and 2007 were analysed to assess 'fast track' effects on two benchmark metrics. In particular, two common presuppositions are that fast-tracked candidates could have decreased clinical phase lengths and higher success rates compared with those without designations. As described here, our analysis of the complex and limited data available suggests that such comparisons should be made cautiously.

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Figure 1: Use of Fast Track (FT) designation, introduced in 1998, has increased significantly since 2002.
Figure 2: Fast Track indications were more frequently terminated and less frequently approved than other indications.
Figure 3: Phase transition probabilities were high in early development.

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Author information

Authors and Affiliations

  1. Janice M. Reichert and Stephanie L. Rochon are at the Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, Massachusetts 02111, USA.,

    Janice M. Reichert & Stephanie L. Rochon

  2. Department of Health Policy and Management, Bodi D. Zhang is at Harvard University, School of Public Health, Kresge 4th Floor, 677 Huntington Avenue, Boston, Massachusetts 02115, USA.,

    Bodi D. Zhang

Authors
  1. Janice M. Reichert
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  2. Stephanie L. Rochon
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  3. Bodi D. Zhang
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Corresponding author

Correspondence to Janice M. Reichert.

Related links

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FURTHER INFORMATION

CBER Fast Track Designation Request Performance Report

CDER Fast track designation (FY 1998-FY 2006)

CDER Response to Request for “Fast Track” Designation FY 2007

FDA Guidance for Industry. Fast Track Drug Development Programs - Designation, Development, and Application Review

US Food and Drug Administration. Fast Track, Accelerated Approval and Priority Review

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Reichert, J., Rochon, S. & Zhang, B. A decade of the Fast Track programme. Nat Rev Drug Discov 7, 885–886 (2008). https://doi.org/10.1038/nrd2733

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