Journal article
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
- Abstract:
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Background:
Expand abstract
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...
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Accepted manuscript, 109.0KB, Terms of use)
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(Preview, Supplementary materials, Accepted manuscript, 90.6KB, Terms of use)
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- Publisher copy:
- 10.1016/s0140-6736(19)33220-9
Authors
- Publisher:
- Elsevier
- Journal:
- Lancet More from this journal
- Volume:
- 395
- Pages:
- 361-369
- Article number:
- 10221
- Publication date:
- 2020-01-17
- Acceptance date:
- 2019-12-19
- DOI:
- EISSN:
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1474-547X
- ISSN:
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0140-6736
- Pmid:
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31958402
- Language:
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English
- Keywords:
- Pubs id:
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1083533
- Local pid:
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pubs:1083533
- Deposit date:
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2020-02-05
Terms of use
- Copyright holder:
- Elsevier
- Copyright date:
- 2020
- Rights statement:
- © 2020 Elsevier Ltd. All rights reserved.
- Notes:
- This is the accepted manuscript version of the article, available under the terms of a Creative Commons, Attribution, Non-Commercial, No Derivatives licence. The final version is available online from Elsevier at: https://doi.org/10.1016/S0140-6736(19)33220-9
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