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Journal article

Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies

Abstract:

Background and objective Novel cancer therapies are often approved with evidence from a single pivotal trial alone. There are concerns about the credibility of this evidence. Higher validity may be indicated by five methodological and statistical characteristics of pivotal trial evidence that were described by the U.S. Food and Drug Administration (FDA), which may corroborate the reliance on a single trial alone for approval decisions.

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1016/j.jclinepi.2019.05.033

Authors


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Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Role:
Author
ORCID:
0000-0002-3301-8085
Publisher:
Elsevier
Journal:
Journal of Clinical Epidemiology More from this journal
Volume:
114
Pages:
49-59
Publication date:
2019-05-31
Acceptance date:
2019-05-28
DOI:
EISSN:
1878-5921
ISSN:
0895-4356
Language:
English
Keywords:
Pubs id:
pubs:1003280
UUID:
uuid:a78ee943-6cfe-4fb9-859e-d7ec82ebec85
Local pid:
pubs:1003280
Source identifiers:
1003280
Deposit date:
2019-05-28

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