Occurrence and determinants of selective reporting of clinical drug trials: Design of an inception cohort study

BMJ Open

Volumn 5, Issue 7, 2015, Pages

  Van Den Bogert, Cornelis A ^a,b,c   Souverein, Patrick C ^a   Brekelmans, Cecile T M ^b   Janssen, Susan W J ^c   Van Hunnik, Manon ^a,c   Koëter, Gerard H ^b   Leufkens, Hubertus G M ^a   Bouter, Lex M ^d  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Central Committee on Research Involving Human Subjects (CCMO)   (Netherlands)

^c NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; HUMAN; PROPORTIONAL HAZARDS MODEL; PUBLICATION; STUDY DESIGN; ETHICS; INFORMATION DISSEMINATION; METHODOLOGY; PROCEDURES; PUBLISHING; RESEARCH ETHICS;

DRUG;

CLINICAL TRIALS AS TOPIC; COHORT STUDIES; ETHICS, RESEARCH; HUMANS; INFORMATION DISSEMINATION; PHARMACEUTICAL PREPARATIONS; PUBLICATION BIAS; PUBLISHING; RESEARCH DESIGN;

EID: 84937220282     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-007827     Document Type: Article

References (53)

1. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191-4.
2. Dixon JR Jr. The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur 1998; 6: 65-74.
3. Bardy AH Bias in reporting clinical trials. Br J Clin Pharmacol 1998; 46: 147-50.
4. Benjamin DK Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 2006; 296: 1266-73.
5. Blumle A, Antes G, Schumacher M, et al. Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others. J Med Ethics 2008; 34:e20.
6. de Jong JP, Ter Riet G, Willems DL. Two prognostic indicators of the publication rate of clinical studies were available during ethical review. J Clin Epidemiol 2010; 63: 1342-50.
7. Decullier E, Chan AW, Chapuis F. Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS Med 2009; 6: e1000034.
8. Decullier E, Lheritier V, Chapuis F. Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005; 331: 19.
9. Easterbrook PJ, Matthews DR. Fate of research studies. J R Soc Med 1992; 85: 71-6.
10. Hemminki E. Study of information submitted by drug companies to licensing authorities. BMJ 1980; 280: 833-6.
11. Hole OP, Nitter-Hauge S, Cederkvist HR, et al. An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results. Eur J Clin Pharmacol 2009; 65: 315-18.
12. Jones CW, Handler L, Crowell KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013; 347: f6104.
13. Kasenda B, von Elm E, You J, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA 2014; 311: 1045-51.
14. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008; 5:e191.
15. Melander H, Ahlqvist-Rastad J, Meijer G, et al. Evidence based medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003; 326: 1171-3.
16. Pich J, Carne X, Arnaiz JA, et al. Role of a research ethics committee in follow-up and publication of results. Lancet 2003; 361: 1015-16.
17. Shamliyan T, Kane RL. Clinical research involving children: registration, completeness, and publication. Pediatrics 2012; 129:e1291-300.
18. Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997; 315: 640-5.
19. von Elm E, Rollin A, Blumle A, et al. Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 2008; 138: 197-203.
20. Ramsey S, Scoggins J. Commentary: practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. Oncologist 2008; 13: 925-9.
21. Easterbrook PJ, Berlin JA, Gopalan R, et al. Publication bias in clinical research. Lancet 1991; 337: 867-72.
22. Cowley AJ, Skene A, Stainer K, et al. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. Int J Cardiol 1993; 40: 161-6.
23. Nowbar AN, Mielewczik M, Karavassilis M, et al. Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis. BMJ 2014; 348:g2688.
24. Dickersin K, Min YI, Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 1992; 267: 374-8.
25. Every-Palmer S, Howick J. How evidence-based medicine is failing due to biased trials and selective publication. J Eval Clin Pract 2014; 20: 908-14.
26. Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010; 340:c365.
27. Saini P, Loke YK, Gamble C, et al. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ 2014; 349:g6501.
28. Smyth RM, Kirkham JJ, Jacoby A, et al. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011; 342:c7153.
29. Institute of Medicine (IOM). Discussion framework for clinical trial data sharing: guiding principles, elements, and activities. Washington DC: The National Academies Press, 2014.
30. Ioannidis JP How to make more published research true. PLoS Med 2014; 11:e1001747.
31. Lee KP, Boyd EA, Holroyd-Leduc JM, et al. Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals. Med J Aust 2006; 184: 621-6.
32. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001; 285: 437-43.
33. Kasenda B, Schandelmaier S, Sun X, et al. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 2014; 349:g4539.
34. Dwan K, Altman DG, Clarke M, 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 2014; 11: e1001666.
35. Chan AW, Hrobjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004; 291: 2457-65.
36. Chan AW, Hrobjartsson A, Jorgensen KJ, et al. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 2008; 337: a2299.
37. Hahn S, Williamson PR, Hutton JL. Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee. J Eval Clin Pract 2002; 8: 353-9.
38. Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 2010; 341:c4737.
39. McGauran N, Wieseler B, Kreis J, et al. Reporting bias in medical research - a narrative review. Trials 2010; 11: 37.
40. Lexchin J. Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medications. Sci Eng Ethics 2012; 18: 247-61.
41. Getz KA Getting to the Heart of Public Distrust. http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Drug+Development/Getting-to-the-Heart-of-Public-Distrust/ArticleStandard/Article/detail/546111 (accessed 12 Sep 2014).
42. ICMJE. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (Update December 2013). http://www.IMCJE.org (accessed 25 Aug 2014).
43. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158: 200-7.
44. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340:c332.
45. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012; 344:d7373.
46. Huic M, Marusic M, Marusic A. Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy. PLoS ONE 2011; 6: e25258.
47. Dwan K, Gamble C, Williamson PR, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review. PLoS ONE 2013; 8:e66844.
48. http://www.ccmo.nl/en/accredited-mrecs (accessed 20 Nov 2014).
49. World Health Organization. International Classfication of Diseases Version 10. http://apps.who.int/classifications/icd10/browse/2015/en (accessed 12 Jan 2015).
50. Communication from the Commission. Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial: article 43 (CT-1). Official Journal of the European Union, 2010.
51. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374: 86-9.
52. Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014; 383: 267-76.
53. Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014; 383: 257-66.