| The value, qualification, and regulatory use of surrogate end points in drug development. | |
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MedLine Citation:
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PMID: 19474783 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The acceptance and use of either surrogate end points (SEPs) or efficient clinical end points are associated with greater and more rapid availability of new medicines as compared with disease situations for which clinical end points are inefficient or no surrogates exist. This review of the history of the development, qualification, and acceptance of key SEPs shows that both successes and failures had three key characteristics: (i) apparent biologic plausibility, (ii) prognostic value for the outcome of the disease, and (iii) an association between changes in the SEP and changes in outcome with therapeutic intervention--the three factors recommended for SEPs in the International Conference on Harmonisation's "Statistical Principles for Clinical Trials." We recommend that only prognostic value be an absolute prerequisite for surrogacy, because therapeutic interventions may not exist a priori, and biological plausibility can be subjective. Ideally, all three of these factors would be traded off against one another in a consistent and transparent risk-management process. |
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Authors:
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C D Lathia; D Amakye; W Dai; C Girman; S Madani; J Mayne; P MacCarthy; P Pertel; L Seman; A Stoch; P Tarantino; C Webster; S Williams; J A Wagner |
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Publication Detail:
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Type: Journal Article; Review Date: 2009-05-27 |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: 86 ISSN: 1532-6535 ISO Abbreviation: Clin. Pharmacol. Ther. Publication Date: 2009 Jul |
Date Detail:
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Created Date: 2009-06-18 Completed Date: 2009-07-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: United States |
Other Details:
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Languages: eng Pagination: 32-43 Citation Subset: AIM; IM |
Affiliation:
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Clinical Pharmacology, Bayer Pharmaceuticals, Montville, New Jersey, USA. chetan.lathia@bayer.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Biological Markers / analysis* Drug Discovery / legislation & jurisprudence*, standards* Humans United States United States Food and Drug Administration / legislation & jurisprudence, standards |
| Chemical | |
Reg. No./Substance:
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0/Biological Markers |
| Comments/Corrections | |
Comment In:
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Clin Pharmacol Ther. 2009 Jul;86(1):26-7
[PMID:
19536121
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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