Regulatory Pathways for New Antimicrobial Agents: Trade-offs to Keep the Perfect From Being the Enemy of the Good
In 2002, Shlaes and Moellering warned that pharmaceutical companies were abandoning antibiotic research and development due to changing regulatory standards regarding noninferiority (NI) clinical trials. NI trials are subject to unique biases that may yield false-positive conclusions. The US Food an...
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| Published in | Clinical pharmacology and therapeutics Vol. 100; no. 6; p. 597 |
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| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
01.12.2016
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| Subjects | |
| Online Access | Get more information |
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| Abstract | In 2002, Shlaes and Moellering warned that pharmaceutical companies were abandoning antibiotic research and development due to changing regulatory standards regarding noninferiority (NI) clinical trials. NI trials are subject to unique biases that may yield false-positive conclusions. The US Food and Drug Administration (FDA) developed guidance to ensure that NI results truly reflect drug efficacy. These changes, intended to reduce uncertainty in trial results, have shaped trial enrollment and conduct in ways that now require reflection. |
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| AbstractList | In 2002, Shlaes and Moellering warned that pharmaceutical companies were abandoning antibiotic research and development due to changing regulatory standards regarding noninferiority (NI) clinical trials. NI trials are subject to unique biases that may yield false-positive conclusions. The US Food and Drug Administration (FDA) developed guidance to ensure that NI results truly reflect drug efficacy. These changes, intended to reduce uncertainty in trial results, have shaped trial enrollment and conduct in ways that now require reflection. |
| Author | Brass, E P Marr, K A Spellberg, B |
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| CitedBy_id | crossref_primary_10_1016_j_ejmech_2020_113002 crossref_primary_10_1021_acsinfecdis_8b00027 crossref_primary_10_1186_s12890_021_01472_z |
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| References | 26962078 - Clin Infect Dis. 2016 Jun 1;62(11):1380-9 11774094 - Clin Infect Dis. 2002 Feb 1;34(3):420-2 27313268 - Clin Infect Dis. 2016 Sep 15;63(6):754-62 22891041 - Clin Infect Dis. 2012 Oct;55(8):1031-46 26179012 - Clin Infect Dis. 2015 Nov 15;61(10):1558-65 26969258 - Lancet Infect Dis. 2016 Jul;16(7):828-37 25670823 - Clin Infect Dis. 2015 May 15;60(10):1462-71 25931244 - Lancet. 2015 May 16;385(9981):1949-56 25056394 - Clin Pharmacol Ther. 2014 Aug;96(2):147-9 |
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| SubjectTerms | Anti-Infective Agents - therapeutic use Clinical Trials as Topic - legislation & jurisprudence Clinical Trials as Topic - methods Clinical Trials as Topic - standards Drug Industry - legislation & jurisprudence Drug Industry - methods Drug Industry - standards Humans Research - standards Research Design Uncertainty United States United States Food and Drug Administration |
| Title | Regulatory Pathways for New Antimicrobial Agents: Trade-offs to Keep the Perfect From Being the Enemy of the Good |
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