Clinical trials.gov and drugs@FDA: A comparison of results reporting for new drug approval trials

Annals of Internal Medicine

Volumn 165, Issue 6, 2016, Pages 421-430

  Schwartz, Lisa M ^a   Woloshin, Steven ^a   Zheng, Eugene ^b   Tse, Tony ^c   Zarin, Deborah A ^c  

^a DARTMOUTH INSTITUTE FOR HEALTH POLICY AND CLINICAL PRACTICE   (United States)

^b Apartment 306 ^*  (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; REGISTER; ADVERSE DRUG REACTION; COMPARATIVE STUDY; FACTUAL DATABASE; LIBRARY; STANDARDS; UNITED STATES; VALIDATION STUDY;

CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; DRUG APPROVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; NATIONAL LIBRARY OF MEDICINE (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84988521908     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M15-2658     Document Type: Article

References (26)

1. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85.
2. ClinicalTrials.gov. ClinicalTrials.gov "basic results" data element definitions (draft). April 2015. Accessed at https://prsinfo.clinicaltrials .gov/results-definitions.html on 24 February 2016.
3. Public Health Service Act, 402(j)(a)(5)(C), amended by Food and Drug Administration Amendments Act.
4. 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. [PMID: 21366476] doi:10.1056/NEJMsa1012065
5. Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311: 1063-5. [PMID: 24618969] doi:10.1001/jama.2013.285634
6. Earley A, Lau J, Uhlig K. Haphazard reporting of deaths in clinical trials: A review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study. BMJ Open. 2013;3. [PMID: 23335556] doi:10.1136/bmjopen-2012-001963
7. Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;160:477-83. [PMID: 24687070] doi:10.7326/M13-0480
8. Chan AW, Hró bjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457-65. [PMID: 15161896]
9. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358:252-60. [PMID: 18199864] doi: 10.1056/NEJMsa065779
10. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361:1963-71. [PMID: 19907043] doi:10.1056/NEJMsa 0906126
11. U.S. Food and Drug Administration. Center for Drug Evaluation and Research manual of policies and procedures. Office of Translational Sciences. Good review practice: statistical review template. MAPP 6010.4. 2012. Accessed at www.fda.gov/downloads/aboutfda /centersoffices/officeofmedicalproductsandtobacco/cder/manual ofpoliciesprocedures/ucm313814.pdf on 24 February 2016.
12. Turner EH. A taxpayer-funded clinical trials registry and results database [Editorial]. PLoS Med. 2004;1:e60. [PMID: 15562322]
13. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: The CLASS study: A randomized controlled trial. Celecoxib Longterm Arthritis Safety Study. JAMA. 2000;284:1247-55. [PMID: 10979111]
14. Jüni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? [Editorial]. BMJ. 2002;324:1287-8. [PMID: 12039807]
15. U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products. 2016. Accessed at www.accessdata.fda.gov/scripts /cder/drugsatfda on 22 April 2016.
16. Turner EH. How to access and process FDA drug approval packages for use in research. BMJ. 2013;347:f5992. [PMID: 24126858] doi:10.1136/bmj.f5992
17. Woloshin S, Schwartz LM. US Food and Drug Administration approval of flibanserin: even the score does not add up. JAMA Intern Med. 2016;176:439-42. [PMID: 26926770] doi:10.1001/jamaintern med.2016.0073
18. Woloshin S, Schwartz LM, Frankel B, Faerber A. US Food and Drug Administration and design of drug approval studies. JAMA. 2014;312:2163-5. [PMID: 25423223] doi:10.1001/jama.2014.13329
19. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: A literature analysis. PLoS Med. 2008;5:e191. [PMID: 18816163] doi:10.1371/journal.pmed.005 0191
20. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5:e217. [PMID: 19067477] doi:10 .1371/journal.pmed.0050217
21. Zarin DA, Tse T, Sheehan J. The proposed rule for U.S. clinical trial registration and results submission. N Engl J Med. 2015;372: 174-80. [PMID: 25539444] doi:10.1056/NEJMsr1414226
22. Chan AW. Access to clinical trial data [Editorial]. BMJ. 2011;342: d80. [PMID: 21228020] doi:10.1136/bmj.d80
23. Miller JD. Registering clinical trial results: The next step. JAMA. 2010;303:773-4. [PMID: 20179288] doi:10.1001/jama.2010.207
24. Gopal AD, Desai NR, Tse T, Ross JS. Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA. 2015;313:1163-5. [PMID: 25781447] doi:10.1001/jama.2015.1697
25. U.S. Food and Drug Administration. Drug trials snapshots. 2016. Accessed at www.fda.gov/Drugs/InformationOnDrugs/ucm412998 .htm on 25 February 2016.
26. Bouder F, Way D, Löfstedt R, Evensen D. Transparency in Europe: A quantitative study. Risk Anal. 2015;35:1210-29. [PMID: 25931009] doi:10.1111/risa.12386