Framing the forum: Medical ethics in large-scale, interventional respiratory clinical trials

Proceedings of the American Thoracic Society

Volumn 4, Issue 2, 2007, Pages 171-175

  Criner, Gerard J ^a  

^a TEMPLE UNIVERSITY HOSPITAL   (United States)

Author keywords

Clinical trial; Ethics; Financial disclosure; Informed consent; Race

Indexed keywords

PLACEBO; ROFECOXIB;

CRITICALLY ILL PATIENT; FINANCIAL MANAGEMENT; HUMAN; INFORMED CONSENT; INTERVENTION STUDY; MEDICAL ETHICS; MEDICAL RESEARCH; OUTCOME ASSESSMENT; PATIENT CARE; PRACTICE GUIDELINE; RACE DIFFERENCE; REVIEW; RISK ASSESSMENT; THROMBOSIS; DRUG INDUSTRY; MEDICAL INFORMATION; MEDICAL PRACTICE; MORTALITY; NOTE;

CLINICAL TRIALS; CRITICAL ILLNESS; DISEASE SUSCEPTIBILITY; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; RESEARCH SUPPORT;

EID: 34248402092     PISSN: 15463222     EISSN: None     Source Type: Journal    
DOI: 10.1513/pats.200701-012GC     Document Type: Review

References (30)

1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711.
2. Grunberg SM, Cefalu WT. The integral role of clinical research in clinical care. N Engl J Med 2003;348:1386-1388.
3. Cooper JD, Patterson GA, Sundaresan RS, Trulock EP, Yusen RD, Pohl MS, Lefrak SS. Results of 150 consecutive bilateral lung volume reduction procedures in patients with severe emphysema. J Thorac Cardiovasc Surg 1996;112:1319-1329.
4. National Emphysema Treatment Trial Research Group. Rationale and design of the National Emphysema Treatment Trial (NETT): a prospective randomized trial of lung volume reduction surgery. J Thorac Cardiovasc Surg 1999;118:518-528.
5. National Emphysema Treatment Trial Research Group. Patients at high risk of death after lung-volume-reduction surgery. N Engl J Med 2001;345:1075-1083.
6. Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 2004;58:1689-1697.
7. Miller FG, Joffe S. Evaluating the therapeutic misconception. Kennedy Inst Eth J 2006;16:353-366.
8. Appelbaum PS, Lidz CW. Re-evaluating the therapeutic misconception: response to Miller and Joffe. Kennedy Inst Eth J 2006;16:367-373.
9. Miller FG, Silverman HJ. The ethical relevance of the standard of care in the design of clinical trials. Am J Respir Crit Care Med 2004;169:562-564.
10. Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. Univ Penn Law Rev 2001;149:645-710.
11. Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C, Vergnion M, Petit P, Carli P. A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group. N Engl J Med 1998;339:1595-1601.
12. Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med 1999;340:409-417.
13. O'Connor GT, Plume SK, Olmstead EM, Morton JR, Maloney CT, Nugent WC, Hernandez F, Jr., Clough R, Leavitt BJ, Coffin LH, et al. A regional intervention to improve the hospital mortality associated with coronary artery bypass graft surgery. The Northern New England Cardiovascular Disease Study Group. JAMA 1996;275:841-846.
14. Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A, Kapral MK; Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med 2004;350:1414-1421.
15. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochbarg MC, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. The VIGOR Study Group. N Engl J Med 2000;343:1520-1528.
16. Newman LA, Lee CT, Parekh LP, Stewart AK, Thomas CR Jr, Beltran RA, Lucci A, Green B, Ota D, Nelson H, American College of Surgeons Oncology Group (ACOSOG) Special Population Committee. Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee. Cancer 2006;106:188-195.
17. Chen J, Rathore SS, Radford MJ, Wang Y, Krumholz HM. Racial differences in the use of cardiac catheterization after acute myocardial infarction. N Engl J Med 2001;344:1443-1449.
18. Epstein AM, Ayanian JZ, Keogh JH, Noonan SJ, Armistead N, Cleary PD, Weissman JS, David-Kasdan JA, Carlson D, Fuller J, et al. Racial disparities in access to renal transplantation: clinically appropriate or due to underuse or overuse? N Engl J Med 2000;343:1537-1544.
19. Young CJ, Gaston RS. Renal transplantation in black Americans. N Engl J Med 2000;343:1545-1552.
20. National Center for Health Statistics, Centers for Disease Control and Prevention. National Health Interview Survey, 2002. Available at: http://www.cdc.gov/nchs/nhis.htm. Accessed November 28, 2006.
21. Ferris TG, Kuhlthau K, Ausiello J, Perrin J, Kahn R. Are minority children the last to benefit from a new technology? Technology diffusion and inhaled corticosteroids for asthma. Med Care 2006;44:81-86.
22. Li HT, Zhang TT, Zhou YQ, Huang QH, Huang J. SLC11A1 (formerly NRAMP1) gene polymorphisms and tuberculosis susceptibility: a meta-analysis. Int J Tuberc Lung Dis 2006;10:3-12.
23. Moolchan ET, Franken FH, Jaszyna-Gasior M. Adolescent nicotine metabolism: ethnoracial differences among dependent smokers. Ethn Dis 2006;16:239-243.
24. Shrestha S, Strathdee SA, Galai N, Oleksyk T, Fallin MD, Mehta S, Schaid D, Vlahov D, O'Brien SJ, Smith MW. Behavioral risk exposure and host genetics of susceptibility of HIV-1 infection. J Infect Dis 2006;193:16-26.
25. Koizumi A, Nomiyama T, Tsukada M, Wada Y, Omae K, Tanaka S, Miyauchi H, Imamiya S, Sakurai H. Evidence on N-acetyltransferase allele-associated metabolism of hydrazine in Japanese workers. J Occup Environ Med 1998;40:217-222.
26. Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002;347:1335-1341.
27. Davidoff F, DeAngelis CD, Drazen JM, Hrey J, Højgaard L, Horton R, Kotzin S, Nicholls MG, Nylenna M, Overbeke AJ, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001;345:825-827.
28. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, Updated October 2005. Available at: www.icmje.org. Accessed November 16, 2006.
29. Bombardier C, Laine L, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, et al. Response to expression of concern regarding VIGOR study. N Engl J Med 2006;354:1196-1198.
30. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N Engl J Med 2006;354:1193.