Public availability of results of trials assessing cancer drugs in the United States

Journal of Clinical Oncology

Volumn 31, Issue 24, 2013, Pages 2998-3003

  Nguyen, Thi Anh Hoa ^a,b,c,d   Dechartres, Agnes ^a,b,c,d   Belgherbi, Soraya ^a,b,c,d   Ravaud, Philippe ^a,b,c,d  

^a HÔTEL DIEU   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c INSERM   (France)

^d French Cochrane Centre   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; COHORT ANALYSIS; FOOD AND DRUG ADMINISTRATION; FUNDING; HUMAN; KAPLAN MEIER METHOD; MALIGNANT NEOPLASM; MEDLINE; NON PROFIT ORGANIZATION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); UNITED STATES; ACCESS TO INFORMATION; CLINICAL TRIAL (TOPIC); FACTUAL DATABASE; LEGAL ASPECT; MEDICAL ETHICS; METHODOLOGY; NEOPLASM; PUBLICATION; STANDARD; STATISTICS;

ACCESS TO INFORMATION; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; ETHICS, MEDICAL; HUMANS; NEOPLASMS; PUBLICATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES;

EID: 84887256101     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.46.9577     Document Type: Article

References (38)

1. Chalmers I, Altman DG: Systematic Reviews. London, United Kingdom, BMJ Publishing Group, 1995
2. Antes G, Chalmers I: Under-reporting of clinical trials is unethical. Lancet 361:978-979, 2003
3. Booth CM, Tannock I: Reflections on medical oncology: 25 years of clinical trials - Where have we come and where are we going? J Clin Oncol 26:6-8, 2008
4. Chalmers I: Underreporting research is scientific misconduct. JAMA 263:1405-1408, 1990
5. Chalmers I, Glasziou P: Avoidable waste in the production and reporting of research evidence. Lancet 374:86-89, 2009
6. Easterbrook PJ, Berlin JA, Gopalan R, et al: Publication bias in clinical research. Lancet 337:867-872, 1991
7. Krzyzanowska MK, Pintilie M, Tannock IF: Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA 290:495-501, 2003
8. Mann H: Publication of full reports of clinical trials. J Clin Oncol 21:4254-4255, 2003
9. Turner EH, Matthews AM, Linardatos E, et al: Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 358: 252-260, 2008
10. Liberati A: An unfinished trip through uncertainties. BMJ 328:531, 2004
11. Liberati A: Need to realign patient-oriented and commercial and academic research. Lancet 378:1777-1778, 2011
12. DeAngelis CD, Drazen JM, Frizelle FA, et al: Clinical trial registration: A statement from the International Committee of Medical Journal Editors. JAMA 292:1363-1364, 2004
13. Ghersi D, Clarke M, Berlin J, et al: Reporting the findings of clinical trials: A discussion paper. Bull World Health Organ 86:492-493, 2008
14. Laine C, Horton R, DeAngelis CD, et al: Clinical trial registration: Looking back and moving ahead. N Engl J Med 356:2734-2736, 2007
15. Lee K, Bacchetti P, Sim I: Publication of clinical trials supporting successful new drug applications: A literature analysis. PLoS Med 5:e191, 2008
16. 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 5:e217, 2008; discussion e217
17. Ross JS, Mulvey GK, Hines EM, et al: Trial publication after registration in ClinicalTrials.gov: A cross-sectional analysis. PLoS Med 6:e1000144, 2009
18. Ross JS, Tse T, Zarin DA, et al: Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ 344:d7292, 2012
19. ClinicalTrials.gov: PRS and U.S. Public Law 110-85, 2011
20. Zarin DA, Tse T: Medicine: Moving toward transparency of clinical trials. Science 319:1340-1342, 2008
21. ClinicalTrials.gov: Data Element Definitions (DRAFT), 2011ClinicalTrials.gov Protocol
22. ClinicalTrials.gov: When do I need to register and submit results: Delayed submission of results. http://clinicaltrials.gov/ct2/manage-recs/ fdaaa WhenDoINeedToRegister
23. Egger M, Smith GD: Bias in location and selection of studies. BMJ 316:61-66, 1998
24. Ioannidis JP: Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 279: 281-286, 1998
25. Bourgeois FT, Murthy S, Mandl KD: Outcome reporting among drug trials registered in ClinicalTrials. gov. Ann Intern Med 153:158-166, 2010
26. Bero L, Oostvogel F, Bacchetti P, et al: Factors associated with findings of published trials of drug-drug comparisons: Why some statins appear more efficacious than others. PLoS Med 4:e184, 2007
27. Emerson GB, Warme WJ, Wolf FM, et al: Testing for the presence of positive-outcome bias in peer review: A randomized controlled trial. Arch Intern Med 170:1934-1939, 2010
28. Rodwin MA, Abramson JD: Clinical trial data as a public good. JAMA 308:871-872, 2012
29. Shamliyan T: Reporting of results of interventional studies by the information service of the National Institutes of Health. Clin Pharmacol 2:169-176, 2010
30. Gopal RK, Yamashita TE, Prochazka AV: Research without results: Inadequate public reporting of clinical trial results. Contemp Clin Trials 33:486-491, 2012
31. Prayle AP, Hurley MN, Smyth AR: Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: Cross sectional study. BMJ 344: d7373, 2012
32. Hawkes N: FDA disagrees with BMJ study that found clinical trials were not being reported. BMJ 344:e3277, 2012
33. Wadman M: FDA says study overestimated non-compliance with data-reporting laws. Nature, News, May 1, 2012, Washington, DC
34. Levêque D: Off-label use of anticancer drugs. Lancet Oncol 9:1102-1107, 2008
35. Turner EH: Reboxetine in depression: All the relevant data? BMJ 341:c6487, 2010
36. Roehr B: FDA given new powers over data reporting to national clinical trials registry. BMJ 345:e6629, 2012
37. Krzyzanowska MK, Pintilie M, Brezden-Masley C, et al: Quality of abstracts describing randomized trials in the proceedings of American Society of Clinical Oncology meetings: Guidelines for improved reporting. J Clin Oncol 22:1993-1999, 2004
38. Booth CM, Le Maître A, Ding K, et al: Presentation of nonfinal results of randomized controlled trials at major oncology meetings. J Clin Oncol 27:3938-3944, 2009