Randomized controlled trials of rheumatoid arthritis registered at clinicaltrials.gov: What gets published and when

Arthritis and Rheumatology

Volumn 66, Issue 10, 2014, Pages 2664-2674

  Khan, Nasim A ^a   Singh, Manisha ^a   Spencer, Horace J ^a   Torralba, Karina D ^b  

^a UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^b LOMA LINDA UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; ANTIRHEUMATIC AGENT;

ARTICLE; HUMAN; OUTCOME ASSESSMENT; PARALLEL DESIGN; PHARMACEUTICAL CARE; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; RHEUMATOID ARTHRITIS; STUDY DESIGN; ARTHRITIS, RHEUMATOID; FACTUAL DATABASE;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DATABASES, FACTUAL; HUMANS; PUBLICATION BIAS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES;

EID: 84908368792     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.38784     Document Type: Article

References (50)

1. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR,. Publication bias in clinical research. Lancet 1991; 337: 867-72.
2. Dickersin K,. How important is publication bias? A synthesis of available data. AIDS Educ Prev 1997; 9: 15-21.
3. 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.
4. Krzyzanowska MK, Pintilie M, Tannock IF,. Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA 2003; 290: 495-501.
5. Decullier E, Lheritier V, Chapuis F,. Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005; 331: 19.
6. Lee K, Bacchetti P, Sim I,. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008; 5: e191.
7. 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.
8. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008; 3: e3081.
9. Song F, Parekh-Bhurke S, Hooper L, Loke YK, Ryder JJ, Sutton AJ, et al. Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies. BMC Med Res Methodol 2009; 9: 79.
10. Ioannidis JP,. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 1998; 279: 281-6.
11. 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.
12. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM,. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009; 6: e1000144.
13. Bourgeois FT, Murthy S, Mandl KD,. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 2010; 153: 158-66.
14. Prenner JL, Driscoll SJ, Fine HF, Salz DA, Roth DB,. Publication rates of registered clinical trials in macular degeneration. Retina 2011; 31: 401-4.
15. Wildt S, Krag A, Gluud L,. Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis. BMJ Open 2011; 1: e000309.
16. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM,. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012; 344: d7292.
17. Shamliyan T, Kane RL,. Clinical research involving children: registration, completeness, and publication. Pediatrics 2012; 129: e1291-300.
18. Smith HN, Bhandari M, Mahomed NN, Jan M, Gandhi R,. Comparison of arthroplasty trial publications after registration in ClinicalTrials.gov. J Arthroplasty 2012; 27: 1283-8.
19. Hurley MN, Prayle AP, Smyth AR,. Delayed publication of clinical trials in cystic fibrosis. J Cyst Fibros 2012; 11: 14-7.
20. Chahal J, Tomescu SS, Ravi B, Bach BR Jr, Ogilvie-Harris D, Mohamed NN, et al. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov. Am J Sports Med 2012; 40: 1970-7.
21. Gordon D, Taddei-Peters W, Mascette A, Antman M, Kaufmann PG, Lauer MS,. Publication of trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med 2013; 369: 1926-34.
22. Stern JM, Simes RJ,. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997; 315: 640-5.
23. Hopewell S, Clarke M, Stewart L, Tierney J,. Time to publication for results of clinical trials. Cochrane Database Syst Rev 2007; MR000011.
24. 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; MR000006.
25. Chalmers I,. Underreporting research is scientific misconduct. JAMA 1990; 263: 1405-8.
26. World Medical Association. Declaration of Helsinki-ethical principles for medical research involving human subjects. URL: http://www.wma.net/en/30publications/10policies/b3/index.html.
27. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gotzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014; 383: 257-66.
28. Simes RJ,. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986; 4: 1529-41.
29. Horton R, Smith R,. Time to register randomised trials: the case is now unanswerable. BMJ 1999; 319: 865-6.
30. National Library of Medicine: National Institutes of Health. ClinicalTrials.gov results database: about the results database. URL: http://clinicaltrials.gov/ct2/info/results.
31. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2004; 292: 1363-4.
32. Zarin DA,. Clinical trial registration. N Engl J Med 2005; 352: 1611.
33. Dickersin K, Rennie D,. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA 2012; 307: 1861-4.
34. Scott DL, Wolfe F, Huizinga TW,. Rheumatoid arthritis. Lancet 2010; 376: 1094-108.
35. Khan NA, Lombeida JI, Singh M, Spencer HJ, Torralba KD,. Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis. Arthritis Rheum 2012; 64: 2059-67.
36. Prayle AP, Hurley MN, Smyth AR,. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012; 344: d7373.
37. Scherer RW, Langenberg P, von Elm E,. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev 2007; MR000005.
38. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG,. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004; 291: 2457-65.
39. Rasmussen N, Lee K, Bero L,. Association of trial registration with the results and conclusions of published trials of new oncology drugs. Trials 2009; 10: 116.
40. Ahmed I, Sutton AJ, Riley RD,. Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey. BMJ 2012; 344: d7762.
41. Parekh-Bhurke S, Kwok CS, Pang C, Hooper L, Loke YK, Ryder JJ, et al. Uptake of methods to deal with publication bias in systematic reviews has increased over time, but there is still much scope for improvement. J Clin Epidemiol 2011; 64: 349-57.
42. Wager E, Williams P, on behalf of the OPEN Project (Overcome failure to Publish nEgative fiNdings) Consortium. "Hardly worth the effort"? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study. BMJ 2013; 347: f5248.
43. 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.
44. Kirillova O,. Results and outcome reporting in ClinicalTrials.gov: what makes it happen? PLoS One 2012; 7: e37847.
45. Rodwin MA, Abramson JD,. Clinical trial data as a public good. JAMA 2012; 308: 871-2.
46. National Research Council. Sharing clinical research data: Workshop Summary. Washington (DC): The National Academies Press; 2013.
47. Clinical Study Data Request. URL: https://www.clinicalstudydatarequest.com/Default.aspx.
48. Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, Leopold SS,. Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial. Arch Intern Med 2010; 170: 1934-9.
49. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P,. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 97784.
50. 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.