Sharing and reporting the results of clinical trials

JAMA - Journal of the American Medical Association

Volumn 313, Issue 4, 2015, Pages 355-356

  Hudson, Kathy L ^a   Collins, Francis S ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; DATA SHARING; DEVICE APPROVAL; DRUG APPROVAL; EVIDENCE BASED PRACTICE; FUNDING; HEALTH CARE POLICY; INFORMATION DISSEMINATION; INTERPERSONAL COMMUNICATION; MEDICAL ETHICS; MEDICAL RESEARCH; NOTE; PUBLICATION; PUBLISHING; SCIENTIFIC LITERATURE; CLINICAL TRIAL (TOPIC); FOOD AND DRUG ADMINISTRATION; LEGISLATION AND JURISPRUDENCE; NATIONAL HEALTH ORGANIZATION; STATISTICS AND NUMERICAL DATA; TRUST; UNITED STATES;

ACCESS TO INFORMATION; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; INFORMATION DISSEMINATION; NATIONAL INSTITUTES OF HEALTH (U.S.); PUBLICATION BIAS; TRUST; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84921781584     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.10716     Document Type: Note

References (10)

1. Executive Office of the President; Office of Science and Technology Policy. Increasing Access to the Results of Federally Funded Scientific Research. February 22, 2013. http://www.whitehouse.gov/sites/default/files/microsites/ostp/ostp-public-access-memo-2013.pdf. Accessed November 17, 2014.
2. Notice of Proposed Rule Making. http://ofr.gov /OFRUpload/OFRData/2014-26197-PI.pdf. Accessed November 18, 2014.
3. Food and Drug Administration Amendments Act of 2007 (FDAAA), 42 USC 282(j).
4. Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain?-a statistical analysis of the ClinicalTrials.gov database. PLoS One. 2014;9(7): e101826.
5. National Institute of Mental Health. Data sharing expectations for NIMH-funded clinical trials. http://grants.nih.gov/grants/guide/notice-files /NOT-MH-14-015.html. Accessed July 25, 2014.
6. European Medicines Agency. Draft policy on publication and access to clinical-trial data, June 2013. http://www.ema.europa.eu/docs/en-GB /document-library/Other/2013/06/WC500144730 .pdf. Accessed July 6, 2014.
7. Pharmaceutical Research and Manufacturers of America; European Federation of Pharmaceutical Industries and Associations. Principles for responsible clinical trial data sharing, our commitment to patients and researchers, 2013. http://www.phrma.org/sites/default/files/pdf /PhRMAPrinciplesForResponsibleClinicalTrialDataSharing .pdf. Accessed November 17, 2014.
8. Yale School of Medicine; Center for Outcomes Research & Evaluation. Yale University Open Access (YODA) Project. http://medicine.yale.edu/core /projects/yodap/index.aspx. Accessed July 6, 2014.
9. ClinicalStudyDataRequest.com. GlaxoSmithKline. https://www .clinicalstudydatarequest.com/. Accessed July 25, 2014.
10. National Institutes of Health. Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. http://grants.nih.gov/grants/guide /notice-files/NOT-OD-15-019.html. Accessed November 19, 2014.