Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles

Journal of Clinical Epidemiology

Volumn 70, Issue , 2016, Pages 26-37

  Pranić, Shelly ^a   Marušić, Ana ^a  

^a UNIVERSITY OF SPLIT   (Croatia)

Author keywords

Bias (epidemiology); Databases; Drug side effects; Factual; Randomized controlled trials as topic; Reporting

Indexed keywords

ACT; ARTICLE; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; FOOD AND DRUG ADMINISTRATION; HUMAN; LAW; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; REGISTRATION; SAMPLE SIZE; DRUG SCREENING; FINANCIAL MANAGEMENT; INFORMATION DISSEMINATION; INTERNET; PRACTICE GUIDELINE; PROCEDURES; PUBLISHING; RESEARCH; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED STATES;

DRUG EVALUATION; EDITORIAL POLICIES; FINANCING, GOVERNMENT; GUIDELINE ADHERENCE; HUMANS; INFORMATION DISSEMINATION; INTERNET; PERIODICALS AS TOPIC; PUBLICATION BIAS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RESEARCH REPORT; RESEARCH SUPPORT AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84957436193     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2015.07.007     Document Type: Article

References (47)

1. K. Dickersin, and D. Rennie Registering clinical trials JAMA 290 2003 516 523
2. C. De Angelis, J.M. Drazen, F.A. Frizelle, C. Haug, J. Hoey, R. Horton, and et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors CMAJ 171 2004 606 607
3. M.J. Fredrickson, and B.M. Ilfeld Prospective trial registration for clinical research: what is it, what is it good for, and why do I care? Reg Anesth Pain Med 36 2011 619 624
4. U.S. National Library of Medicine ClinicalTrials.gov background 2014 U.S. National Library of Medicine Bethesda, MD Available at https://clinicaltrials.gov/ct2/about-site/background Accessed January 2, 2015
5. R.F. Viergever, and D. Ghersi The ClinicalTrials.gov results database N Engl J Med 364 2011 2169 2170 author reply 70
6. European Medicines Agency European Medicines Agency launches a new version of EudraCT: summary results of clinical trials soon to be available to the public 2013 European Medicines Agency London Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fnews-and-events%2Fnews%2F2013%2F10%2Fnews-detail-001918.jsp Accessed February 2, 2015
7. European Medicines Agency Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014 2014 European Medicines Agency London Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2014/06/news-detail-002127.jsp&mid=WC0b01ac058004d5c1 Accessed February 2, 2015
8. European Medicines Agency About the EU clinical trials register 2015 European Medicines Agency London Available at https://www.clinicaltrialsregister.eu/about.html Accessed January 5, 2015
9. Food and Drug Administration Amendments Act of 2007, 21 U.S.C. Public Law 110-85. Sect. 801 (2007).
10. M. Huic, M. Marusic, and A. Marusic Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy PLoS One 6 2011 e25258
11. T. Tse, R.J. Williams, and D.A. Zarin Reporting "basic results" in ClinicalTrials.gov Chest 136 2009 295 303
12. C.D. De Angelis, J.M. Drazen, F.A. Frizelle, C. Haug, J. Hoey, R. Horton, and et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors Ann Intern Med 143 2005 146 148
13. World Health Organization WHO Data Set 2015 World Health Organization Geneva, Switzerland Available at http://www.who.int/ictrp/network/trds/en/ Accessed January 7, 2015
14. S. Al-Marzouki, I. Roberts, S. Evans, and T. Marshall Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet Lancet 372 2008 201
15. D.A. Zarin, T. Tse, R.J. Williams, R.M. Califf, and N.C. Ide The ClinicalTrials.gov results database-update and key issues N Engl J Med 364 2011 852 860
16. D.M. Hartung, D.A. Zarin, J.M. Guise, M. McDonagh, R. Paynter, and M. Helfand Reporting discrepancies between ClinicalTrials.gov the results database and peer-reviewed publications Ann Intern Med 160 2014 477 483
17. J.E. Becker, H.M. Krumholz, G. Ben-Josef, and J.S. Ross Reporting of results in ClinicalTrials.gov and high-impact journals JAMA 311 2014 1063 1065
18. D.A. Zarin, N.C. Ide, T. Tse, W.R. Harlan, J.C. West, and D.A. Lindberg Issues in the registration of clinical trials JAMA 297 2007 2112 2120
19. R.M. Califf, D.A. Zarin, J.M. Kramer, R.E. Sherman, L.H. Aberle, and A. Tasneem Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010 JAMA 307 2012 1838 1847
20. C. Riveros, A. Dechartres, E. Perrodeau, R. Haneef, I. Boutron, and P. Ravaud Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals PLos Med 10 2013 e1001566 discussion e1001566
21. World Health Organization WHO statement on public disclosure of clinical trial results Geneva, Switzerland 2015 Available at http://www.who.int/ictrp/results/reporting Accessed June 14, 2015
22. U.S. National Library of Medicine Clinical trial registry numbers in MEDLINE/PubMed Records 2014 U.S. National Library of Medicine Bethesda, MD
23. U.S. Food and Drug Administration Safety: what is a serious adverse event? 2014 U.S. Food and Drug Administration Sliver Spring, MD Available at http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm Accessed January 5, 2015
24. A.W. Chan, A. Hrobjartsson, M.T. Haahr, P.C. Gotzsche, and D.G. Altman Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles JAMA 291 2004 2457 2465
25. S. Mathieu, I. Boutron, D. Moher, D.G. Altman, and P. Ravaud Comparison of registered and published primary outcomes in randomized controlled trials JAMA 302 2009 977 984
26. J.S. Ross, G.K. Mulvey, E.M. Hines, S.E. Nissen, and H.M. Krumholz Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis PLos Med 6 2009 e1000144
27. S. Mathieu, A.W. Chan, and P. Ravaud Use of trial register information during the peer review process PLoS One 8 2013 e59910
28. G. Hannink, H.G. Gooszen, and M.M. Rovers Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions Ann Surg 257 5 2013 818 823
29. S. Killeen, P. Sourallous, I.A. Hunter, J.E. Hartley, and H.L. Grady Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals Ann Surg 259 1 2014 193 196
30. K. Dwan, C. Gamble, P.R. Williamson, and J.J. Kirkham Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review PLoS One 8 2013 e66844
31. M.J. To, J. Jones, M. Emara, and A.R. Jadad Are reports of randomized controlled trials improving over time? A systematic review of 284 articles published in high-impact general and specialized medical journals PLoS one 8 2013 e84779
32. J. Peron, G.R. Pond, H.K. Gan, E.X. Chen, R. Almufti, D. Maillet, and et al. Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review J Natl Cancer Inst 104 2012 982 989
33. International Committee of Medical Journal Editors ICMJE recommendations ("The Uniform Requirements"), which journals follow the recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals (ICMJE recommendations)? 2015 Available at http://www.icmje.org/about-icmje/faqs/icmje-recommendations/#5 Accessed June 14, 2015
34. I. Sim, A.W. Chan, A.M. Gulmezoglu, T. Evans, and T. Pang Clinical trial registration: transparency is the watchword Lancet 367 2006 1631 1633
35. D. Strech Normative arguments and new solutions for the unbiased registration and publication of clinical trials J Clin Epidemiol 65 2012 276 281
36. A.J. Wood Progress and deficiencies in the registration of clinical trials N Engl J Med 360 2009 824 830
37. Notice of proposed rulemaking: clinical trials registration and results submission Fed Regist 79 2014 69599 69680 https://federalregister.gov/a/2014-26197
38. J.P. Ioannidis Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials JAMA 279 1998 281 286
39. E. Decullier, V. Lheritier, and F. Chapuis Fate of biomedical research protocols and publication bias in France: retrospective cohort study BMJ 331 2005 19
40. J. Ioannidis, and J. Lau Evolution of treatment effects over time: empirical insight from recursive cumulative metaanalyses Proc Natl Acad Sci U S A 98 2001 831 836
41. R.W. Scherer, P. Langenberg, and E. von Elm Full publication of results initially presented in abstracts Cochrane Database Syst Rev 2007 MR000005
42. J.M. Stern, and R.J. Simes Publication bias: evidence of delayed publication in a cohort study of clinical research projects BMJ 315 1997 640 645
43. T.A. Trikalinos, R. Churchill, M. Ferri, S. Leucht, A. Tuunainen, K. Wahlbeck, and et al. Effect sizes in cumulative meta-analyses of mental health randomized trials evolved over time J Clin Epidemiol 57 2004 1124 1130
44. K. Dwan, D.G. Altman, M. Clarke, C. Gamble, J.P. Higgins, J.A. Sterne, and et al. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials PLos Med 11 2014 e1001666
45. A. Earley, J. Lau, and K. Uhlig Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications- A cross-sectional study BMJ Open 3 2013 e001963
46. L. Manzoli, M.E. Flacco, M. D'Addario, L. Capasso, C. De Vito, C. Marzuillo, and et al. Non-publication and delayed publication of randomized trials on vaccines: survey BMJ 348 2014 g3058
47. K. Krleza-Jeric, A.W. Chan, K. Dickersin, I. Sim, J. Grimshaw, and C. Gluud Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1) BMJ 330 2005 956 958