Ethical considerations in the interpretation and communication of clinical trial results

Proceedings of the American Thoracic Society

Volumn 4, Issue 2, 2007, Pages 194-198

  Coultas, David ^a  

^a Health Science Center   (United States)

Author keywords

Bias; Clinical trial; Data interpretation; Ethics; Publications; Research misconduct

Indexed keywords

COMMUNICATION SKILL; ENVIRONMENTAL FACTOR; GOVERNMENT; HUMAN; KNOWLEDGE; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; PATIENT EDUCATION; PHYSICIAN; PUBLICATION; REVIEW; RISK ASSESSMENT; SCIENTIFIC MISCONDUCT; TRUST; VALIDITY;

CLINICAL PROTOCOLS; CLINICAL TRIALS; COMMUNICATION; ETHICS, RESEARCH; HUMANS; PUBLICATION BIAS; PUBLISHING; REGISTRIES; RESEARCH PERSONNEL; SCIENTIFIC MISCONDUCT;

EID: 34248339662     PISSN: 15463222     EISSN: None     Source Type: Journal    
DOI: 10.1513/pats.200701-007GC     Document Type: Review

References (39)

1. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., "Comparison of upper gastrointestinal toxicity of Rofecoxib and Naproxen in patients with rheumatoid arthritis," N Engl J Med 2000;343:1520-8.
2. N Engl J Med 2005;353:2813-2814.
3. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N Engl J Med 2006;354:1193.
4. Sleight P. Where are clinical trials going? Society and clinical trials. J Intern Med 2004;255:151-158.
5. Ray WA, Stein M. Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med 2006;354:194-201.
6. Tumber MB, Dickersin K. Publication of clinical trials: accountability and accessibility. J Intern Med 2004;256:271-283.
7. Benos DJ, Fabres J, Farmer J, Gutierrez JP, Hennessy K, Kosek D, Lee JM, Olteana D, Russell T, Shaikh F, et al. Ethics and scientific publication. Adv Physiol Educ 2005;29:59-74.
8. Martinson BC, Anderson MS, de Vries R. Scientists behaving badly. Nature 2005;435:737-738.
9. Al-Marzouki S, Roberts I, Marshall T, Evans S. The effect of scientific misconduct on the results of clinical trials: a Delphi survey. Contemp Clin Trials 2005;26:331-337.
10. Gardner W, Lidz CW, Hartwig KC. Authors' reports about research integrity problems in clinical trials. Contemp Clin Trials 2005;26:244-251.
11. Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science. Office of Research Integrity annual report 2005. Available from: http://ori.dhhs.gov/documents/annual_reports/ ori_annual_report_2005.pdf (accessed October 28, 2006).
12. Reynolds SM. ORI findings of scientific misconduct in clinical trials and publicly funded research, 1992-2002. Clin Trials 2004;1:509-516.
13. The Committee on Publication Ethics. The COPE report 2005. Available from: http://www.publicationethics.org.uk/reports/2005/foreword/ (accessed October 28, 2006).
14. Chan A, 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.
15. Chan A, 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.
16. Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ 2005;330:753.
17. Camacho LH, Bacik J, Cheung A, Spriggs DR. Presentation and subsequent publication rates of phase I oncology clinical trials. Cancer 2005;104:497-504.
18. Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, ZhuQ, Reiling J, Pace B. Publication bias in editorial decision making. JAMA 2002;287:2825-2828.
19. Roig M. Commentary: ethical writing should be taught. BMJ 2006;333:596-597.
20. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663-694.
21. Association of American Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress: policy and guidelines for the oversight of individual financial interests in human subjects research. Washington, DC: Association of American Medical Colleges; 2001. Available from: http://www.aamc.org/research/ coi/firstreport.pdf (accessed October 28, 2006).
22. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005;352:2202-2210.
23. Steinbrook R. Public registration of clinical trials. N Engl JMed 2004;351:315-317.
24. Krleza-Jeric K, Chan A, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005;330:956-959.
25. Drazen JM, Wood AJ. Trial registration report card. N Engl J Med 2005;353:2809-2811.
26. Haug C, Gotzsche PC, Schroeder TV. Registries and registration of clinical trials. N Engl J Med 2005;353:2811-2812.
27. Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2005;353:2779-2787.
28. DeAngelis C, Drazen JM, Frizelle FA, Huang C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJPM, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2004;292:1363-1364.
29. Manheimer E, Anderson D. Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility. BMJ 2002;325:528-531.
30. Fisher CB.Clinical trials results databases: unanswered questions. Science 2006;311:180-181.
31. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA 1994;272:1926-1931.
32. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Ann Intern Med 1994;121:894-895.
33. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637-639.
34. Rothwell PM. External validity of randomised controlled trials: to whom do the results of this trial apply? Lancet 2005;365:82-93.
35. Phillips LS, Branch WT Jr, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med 2001;135:825-834.
36. Committee on Quality of Health Care in America, Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press; 2001.
37. Al-Marzouki S, Evans S, Marshall T, Roberts I. Are these data real? Statistical methods for the detection of data fabrication in clinical trials. BMJ 2005;331:267-270.
38. Frank M. Access to the scientific literature: a difficult balance. N Engl J Med 2006;354:1552-1555.
39. Giles J. Researchers break the rules in frustration at review boards. Nature 2005;438:136-137.