Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission-Reference-Cited by-同舟云学术

Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission

Published:2021-08-01 Issue:8 Volume:181 Page:1128
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

DeVito Nicholas J.¹,Goldacre Ben¹

Affiliation:

1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2780022/jamainternal_devito_2021_ld_210022_1627675007.55115.pdf

Reference6 articles.

1. Trial reporting in ClinicalTrials.gov—the final rule.;Zarin;N Engl J Med,2016

2. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study.;DeVito;Lancet,2020

3. ClinicalTrials.gov reporting: strategies for success at an academic health center.;O’Reilly;Clin Transl Sci,2015

4. Overcoming non-compliance with clinical trial registration and results reporting: One Institution’s approach.;Snider;Contemp Clin Trials Commun,2020

5. Silverman? E. FDA finalizes penalties for trial sponsors, but critics say they fall short. STAT News. Published August 18, 2020. Accessed October 18, 2020. https://www.statnews.com/pharmalot/2020/08/18/fda-clinical-trials-transparency-nih/

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