Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: Cross sectional study

BMJ (Online)

Volumn 344, Issue 7838, 2012, Pages

  Prayle, Andrew P ^a   Hurley, Matthew N ^a   Smyth, Alan R ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; GENERIC DRUG;

ARTICLE; COMPUTER SYSTEM; CROSS-SECTIONAL STUDY; DATA BASE; DRUG APPROVAL; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT; FUNDING; HUMAN; INFORMATION PROCESSING; MANDATORY REPORTING; MEDICAL INFORMATION; MEDICOLEGAL ASPECT; PRIORITY JOURNAL; UNITED STATES;

CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; DATABASES, FACTUAL; DISCLOSURE; GOVERNMENT REGULATION; MANDATORY PROGRAMS; REGISTRIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859005251     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d7373     Document Type: Article

References (15)

1. Food and Drug Administration. Modernization Act of 1997. Public Law No 105-115, 1997.
2. McCray AT, Ide NC. Design and implementation of a national clinical trials registry. J Am Med Inform Assoc 2000;7:313-23. (Pubitemid 30314119)
3. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, et al. Clinical trial registration - looking back and moving ahead. N Engl J Med 2007;356:2734-6. (Pubitemid 47001046)
4. Food and Drug Administration. Amendments Act of 2007. Public Law No 110-85, 2007.
5. Tse T, Williams RJ, Zarin DA. Reporting "basic results" in ClinicalTrials.gov. Chest 2009;136:295-303.
6. Wood AJ. Progress and deficiencies in the registration of clinical trials. N Engl J Med 2009;360:824-30.
7. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008;3:e3081.
8. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database - update and key issues. N Engl J Med 2011;364:852-60.
9. R Development Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing, 2010.
10. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev 2011;1:MR000031.
11. Higgins JPT, Green S, Cochrane C. Cochrane handbook for systematic reviews of interventions. Wiley-Blackwell, 2008.
12. Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997;315:640-5. (Pubitemid 27387174)
13. Hopewell S, Clarke M, Stewart L, Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst Rev 2007;2:MR000011.
14. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009;1:MR000006.
15. Dickersin K, Olson CM, Rennie D, Cook D, Flanagin A, Zhu Q, et al. Association between time interval to publication and statistical significance. JAMA 2002;287:2829-31. (Pubitemid 34591976)