Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases
- PMID: 31502248
- DOI: 10.1002/cpt.1627
Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases
Abstract
We gathered data from three pipeline databases and other public sources on development stage and clinical trial metrics for 1,914 investigational drugs, biologics, and vaccines and 2,769 clinical trials intended to treat a wide variety of infectious diseases. We included new molecular entities (NMEs), new formulations, and new combinations. Clinical trial times decreased from 2000-2008 to 2009-2017, varied by disease class, and were longer for trials with more subjects or more sites. Clinical approval success rates were higher for this set of diseases than those in the published literature for drugs across all therapeutic categories. NMEs to treat HIV had a success rate (16.0%) that was similar to those for drugs in general, whereas NME success rates for influenza and pneumonia were much higher (48.1% and 50.5%, respectively).
© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
Comment in
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Finding New Drugs for Infectious Diseases: Development Times and Success Rates.Clin Pharmacol Ther. 2020 Feb;107(2):305-307. doi: 10.1002/cpt.1728. Clin Pharmacol Ther. 2020. PMID: 31960965 No abstract available.
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