Obstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials

Trials

Volumn 11, Issue , 2010, Pages

  McKenzie, Joanne E ^a,b   Herbison, G Peter ^b   Roth, Paul ^b   Paul, Charlotte ^b  

^a MONASH UNIVERSITY   (Australia)

^b UNIVERSITY OF OTAGO   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CASE STUDY; INFORMED CONSENT; INSTITUTIONAL ETHICS; LAW; LEGAL ASPECT; METHODOLOGY; NEW ZEALAND; PUBLICATION; RESEARCH ETHICS; CONFIDENTIALITY; EPIDEMIOLOGY; ETHICS; EVIDENCE BASED MEDICINE; HUMAN; INTERPERSONAL COMMUNICATION; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; STATISTICAL ANALYSIS; STATISTICS; TREATMENT OUTCOME;

ACCESS TO INFORMATION; BIAS (EPIDEMIOLOGY); CONFIDENTIALITY; DATA INTERPRETATION, STATISTICAL; DISCLOSURE; ETHICS COMMITTEES; EVIDENCE-BASED MEDICINE; HUMANS; INFORMED CONSENT; NEW ZEALAND; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 77951162861     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-11-28     Document Type: Article

References (46)

1. Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet 2002, 359:57-61. 10.1016/S0140-6736(02)07283-5, 11809203.
2. Agha R, Cooper D, Muir G. The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 2007, 5:413-422. 10.1016/j.ijsu.2007.06.002, 18029237.
3. Cowan J, Lozano-Calderon S, Ring D. Quality of prospective controlled randomized trials. Analysis of trials of treatment for lateral epicondylitis as an example. J Bone Joint Surg Am 2007, 89:1693-1699. 10.2106/JBJS.F.00858, 17671006.
4. Farrokhyar F, Chu R, Whitlock R, Thabane L. A systematic review of the quality of publications reporting coronary artery bypass grafting trials. Can J Surg 2007, 50:266-277. 2386171, 17897515.
5. Kane RL, Wang J, Garrard J. Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol 2007, 60:241-249. 10.1016/j.jclinepi.2006.06.016, 17292017.
6. Thabane L, Chu R, Cuddy K, Douketis J. What is the quality of reporting in weight loss intervention studies? A systematic review of randomized controlled trials. Int J Obes (Lond) 2007, 31:1554-1559. 10.1038/sj.ijo.0803640, 17452988.
7. Juni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ 2001, 323:42-46. 10.1136/bmj.323.7303.42, 1120670, 11440947.
8. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995, 273:408-412. 10.1001/jama.273.5.408, 7823387.
9. Pildal J, Hrobjartsson A, Jorgensen KJ, Hilden J, Altman DG, Gotzsche PC. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol 2007, 36:847-857. 10.1093/ije/dym087, 17517809.
10. Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008, 336:601-605. 10.1136/bmj.39465.451748.AD, 2267990, 18316340.
11. Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ 2005, 330:753. 10.1136/bmj.38356.424606.8F, 555875, 15681569.
12. 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, 291:2457-2465. 10.1001/jama.291.20.2457, 15161896.
13. Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004, 171:735-740. 517858, 15451835.
14. Furukawa TA, Watanabe N, Omori IM, Montori VM, Guyatt GH. Association between unreported outcomes and effect size estimates in Cochrane meta-analyses. JAMA 2007, 297:468-470. 10.1001/jama.297.5.468-b, 17284696.
15. Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. Lancet 2008, 372:201. 10.1016/S0140-6736(08)61060-0, 18640445.
16. 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, 358:252-260. 10.1056/NEJMsa065779, 18199864.
17. 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. 10.1371/journal.pmed.0050217, 2586350, 19067477.
18. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008, 3:e3081. 10.1371/journal.pone.0003081, 2518111, 18769481.
19. Williamson PR. Identification and impact of outcome selection bias in meta-analysis. Stat Med 2005, 24:1547-1561. 10.1002/sim.2025, 15580591.
20. Williamson PR, Gamble C, Altman DG, Hutton JL. Outcome selection bias in meta-analysis. Stat Methods Med Res 2005, 14:515-524. 10.1191/0962280205sm415oa, 16248351.
21. Moher D. Reporting research results: a moral obligation for all researchers. Can J Anaesth 2007, 54:331-335. 10.1007/BF03022653, 17470882.
22. Ramsey S, Scoggins J. Commentary: practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. Oncologist 2008, 13:925-929. 10.1634/theoncologist.2008-0133, 2675281, 18794216.
23. Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997, 315:640-645. 2127436, 9310565.
24. Altman D, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne DR, Gotzsche PC, Lang T. The revised CONSORT Statement for Reporting Randomized Traials: Explanation and Elaboration. Ann Intern Med 2001, 134:663-694.
25. 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, 8:353-359. 10.1046/j.1365-2753.2002.00314.x, 12164983.
26. Cook S. Manual for chairpersons of health and disability ethics committees. 2004, , http://www.ethicscommittees.health.govt.nz/
27. Health Research Council Guidelines on Ethics in Health Research. 2002, Health Research Council, (Revised 2005), Health Research Council.
28. National Ethics Advisory Committee Ethical guidelines for observational studies: Observational research, audits and related activities. 2006, Wellington: Ministry of Health, National Ethics Advisory Committee.
29. Evans S. When and how can endpoints be changed after initiation of a randomized clinical trial?. PLoS Clin Trials 2007, 2:e18. 10.1371/journal.pctr.0020018, 1852589, 17443237.
30. Sim I, Chan AW, Gulmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006, 367:1631-1633. 10.1016/S0140-6736(06)68708-4, 16714166.
31. Wendler D, Krohmal B, Emanuel EJ, Grady C. Why patients continue to participate in clinical research. Arch Intern Med 2008, 168:1294-1299. 10.1001/archinte.168.12.1294, 18574086.
32. Chan AW, Upshur R, Singh JA, Ghersi D, Chapuis F, Altman DG. Research protocols: Waiving confidentiality for the greater good. BMJ 2006, 332:1086-1089. 10.1136/bmj.332.7549.1086, 1458595, 16675819.
33. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Weyden MB. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Ann Intern Med 2004, 141:477-478.
34. International Clinical Trials Registry Platform. , http://www.who.int/ictrp/about/en/
35. Ethical Principles for Medical Research Involving Human Subjects. , http://www.wma.net/en/30publications/10policies/b3/index.html
36. United States Code (2008) US Public Law 110-85 Food and Drug Administration Amendments Act of 2007. United States Code (2008) US Public Law 110-85.
37. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006, 185:263-267.
38. Jonsen AR. Of balloons and bicycles or the relationship between ethical theory and practical judgment. Hastings Cent Rep 1991, 21:14-17. 10.2307/3562885, 1743945.
39. Paul C. Health researchers' views of ethics committee functioning in New Zealand. N Z Med J 2000, 113:210-214.
40. Hughes FJ. Assessing the effects of bias on the magnitude of outcomes in clinical studies: lessons for the research community?. J Clin Periodontol 2008, 35:773-774. 10.1111/j.1600-051X.2008.01300.x, 18840152.
41. Angell EL, Bryman A, Ashcroft RE, Dixon-Woods M. An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examined. Qual Saf Health Care 2008, 17:131-136. 10.1136/qshc.2007.022756, 18385408.
42. Babl FE, Sharwood LN. Research governance: current knowledge among clinical researchers. Med J Aust 2008, 188:649-652.
43. Ashcroft R, Pfeffer N. Ethics behind closed doors: do research ethics committees need secrecy?. BMJ 2001, 322:1294-1296. 10.1136/bmj.322.7297.1294, 1120387, 11375236.
44. Schüklenk U, Lott JP. Bioethics and (Public) Policy Advice. Bioethics in a Small World 2005, Berlin, Heidelberg: Springer-Verlag Berlin Heidelberg, Thiele F, Ashcroft RE, Wèutscher F.
45. Chan A-W. Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results. PLoS Med 2008, 5:e230. 10.1371/journal.pmed.0050230, 2586359, 19067481.
46. About the Cochrane Collaboration. , http://www.cochrane.org/docs/descrip.htm