Warning About Shortcuts in Drug Development
- PMID: 28325714
- PMCID: PMC5524047
- DOI: 10.1161/JAHA.117.005737
Warning About Shortcuts in Drug Development
Keywords: Editorials; biomarkers; ethics and policy.
Comment on
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Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990-2011.J Am Heart Assoc. 2017 Mar 21;6(3):e005285. doi: 10.1161/JAHA.116.005285. J Am Heart Assoc. 2017. PMID: 28325713 Free PMC article. Review.
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References
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- Kaplan S. Trump considers naming FDA chief who would radically overhaul the agency. December 7, 2016. Available at: https://www.statnews.com/2016/12/07/trump-fda-oneill/. Accessed February 21, 2017.
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- Bikdeli B, Punnanithinont N, Akram Y, Lee I, Desai N, Ross J, Krumholz H. Two decades of cardiovascular trials with primary surrogate endpoints: 1990–2011. J Am Heart Assoc. 2017;6:e005285 DOI: 10.1161/JAHA.116.005285. - DOI - PMC - PubMed
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- Smietana K, Siatkowski M, Moller M. Trends in clinical success rates. Nat Rev Drug Discov. 2016;15:379–380. - PubMed
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- FDA‐NIH Working Group . BEST (Biomarkers, EndpointS, and other Tools) resource. Available at: https://www.ncbi.nlm.nih.gov/books/NBK326791/. Accessed February 20, 2017.
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