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Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study

Abstract:

Background:
Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this...

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Publication status:
Published
Peer review status:
Peer reviewed

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Files:
Publisher copy:
10.1016/s0140-6736(19)33220-9

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0001-8286-1995
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Oxford college:
Somerville College
Role:
Author
ORCID:
0000-0002-5127-4728
Publisher:
Elsevier Publisher's website
Journal:
Lancet Journal website
Volume:
395
Article number:
10221
Pages:
361-369
Publication date:
2020-01-17
Acceptance date:
2019-12-19
DOI:
EISSN:
1474-547X
ISSN:
0140-6736
Pmid:
31958402
Language:
English
Keywords:
Pubs id:
1083533
Local pid:
pubs:1083533
Deposit date:
2020-02-05

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