Clinical development success rates for investigational drugs

Journal name:
Nature Biotechnology
Volume:
32,
Pages:
40–51
Year published:
DOI:
doi:10.1038/nbt.2786
Published online

The most comprehensive survey of clinical success rates across the drug industry to date shows productivity may be even lower than previous estimates.

At a glance

Figures

  1. Phase success and LOA rates.
    Figure 1: Phase success and LOA rates.

    (a) Phase success rates for lead and all indications. The rates represent the probability that a drug will successfully advance to the next phase. (b) LOA from phase 1 for lead and all indications. Rates denote the probability of FDA approval for drugs in phase 1 development.

  2. Phase success and LOA from phase 1 by disease for all indications.
    Figure 2: Phase success and LOA from phase 1 by disease for all indications.

    The bars represent phase 2 and phase 3 success rates and the line represents LOA from phase 1.

  3. NDA/BLA success rates.
    Figure 3: NDA/BLA success rates.

    (a) Cumulative approval rates by FDA review from 2005 to 2011 (914 reviews). (b) Cumulative and first FDA approval rates by disease.

  4. Root-cause analysis for 359 phase 3 and 95 NDA/BLA suspended programs.
    Figure 4: Root-cause analysis for 359 phase 3 and 95 NDA/BLA suspended programs.

    A program was designated as 'suspended' when conclusive evidence had been gathered regarding a company's plans to discontinue development or communications with regulators were not reinitiated for several years.

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Author information

Affiliations

  1. Michael Hay and Jesse Rosenthal are at BioMedTracker, Sagient Research Systems, San Diego, California, USA

  2. David W. Thomas and Celia Economides are at the Biotechnology Industry Organization (BIO), Washington, DC, USA

  3. John L. Craighead is at Biotech Strategy & Analytics, Rockville, Maryland, USA.

Competing financial interests

M.H. and J.R. are employees of Sagient Research Systems, Inc. D.W.T. is an employee of Biotechnology Industry Organization. J.L.C. is the owner of Biotech Strategy & Analytics. C.E. is an employee of Prosensa Holding N.V.

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