Attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials

Journal of Clinical Oncology

Volumn 25, Issue 23, 2007, Pages 3488-3494

  Gray, Stacy W ^a   Hlubocky, Fay J ^a   Ratain, Mark J ^a   Daugherty, Christopher K ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER PATIENT; CANCER RESEARCH; CLINICAL FEATURE; CLINICAL RESEARCH; CONFLICT OF INTEREST; CONTROLLED STUDY; FEMALE; FINANCIAL MANAGEMENT; HEALTH SURVEY; HUMAN; INTERPERSONAL COMMUNICATION; MAJOR CLINICAL STUDY; MALE; PATIENT ATTITUDE; PATIENT PARTICIPATION; PRIORITY JOURNAL; STRUCTURED INTERVIEW;

ADULT; AGED; AGED, 80 AND OVER; ATTITUDE OF HEALTH PERSONNEL; CLINICAL TRIALS; CONFLICT OF INTEREST; FEMALE; HUMANS; MALE; MEDICAL ONCOLOGY; MIDDLE AGED; NEOPLASMS; RESEARCH; RESEARCH DESIGN; RESEARCH SUBJECTS;

EID: 34548183801     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.11.7283     Document Type: Article

References (52)

1. Bayh-Dole Act 1980, 35 USC §200-212
2. Klanica K: Conflicts of interest in medical research: How much conflict should exceed legal boundaries? J Biolaw Bus 8:37-45, 2005
3. Bodenheimer T: Uneasy alliance: Clinical investigators and the pharmaceutical industry. N Engl J Med 342:1539-1544, 2000
4. Bekelman JE, Li Y, Gross CP: Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA 289:454-465, 2003
5. Stossel TP: Regulating academic-industrial research relationships: Solving problems or stifling progress? N Engl J Med 353:1060-1065, 2005
6. Martin JB, Kasper DL: In whose best interest? Breaching the academic-industrial wall. N Engl J Med 343:1646-1649, 2000
7. AAMC: Protecting subjects, preserving trust, promoting progress: II - Principles and recommendations for oversight of an institution's financial interests in human subject research. Acad Med 78:237-245, 2003
8. AAMC: Protecting subjects, preserving trust, promoting progress: I - Policy and guidelines for the oversight of individual financial interests in human subjects research. Acad Med 78:225-236, 2003
9. World Medical Association's revision in 2000 of the Declaration of Helsinki. http://www.wma.net/ e/policy/b3.htm
10. The Association of American Universities: Task Force on Research Accountability: Report on individual and institutional financial conflicts of interest. Association of American Universities, 2001. http://www.aau.edu/ research/COI.01.pdf
11. Thompson DF: Understanding financial conflicts of interest. N Engl J Med 329:573-576, 1993
12. Sollitto S, Hoffman S, Mehlman M, et al: Intrinsic conflicts of interest in clinical research: A need for disclosure. Kennedy Inst Ethics J 13:83-91, 2003
13. Levinsky NG: Nonfinancial conflicts of interest in research. N Engl J Med 347:759-761, 2002
14. Deceit in research. Lancet 1:1211, 1983
15. Budiansky S: Data falsification: NIH decrees ten-year ban on research grants. Nature 301:645, 1983
16. Ranstam J, Buyse M, George SL, et al: Fraud in medical research: An international survey of biostatisticians - ISCB Subcommittee on Fraud. Control Clin Trials 21:415-427, 2000
17. Stelfox HT, Chua G, O'Rourke K, et al: Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 338:101-106, 1998
18. Lexchin J, Bero LA, Djulbegovic B, et al: Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ 326: 1167-1170, 2003
19. Als-Nielsen B, Chen W, Gluud C, et al: Association of funding and conclusions in randomized drug trials: A reflection of treatment effect or adverse events? JAMA 290:921-928, 2003
20. Cho MK, Bero LA: The quality of drug studies published in symposium proceedings. Ann Intern Med 124:485-489, 1996
21. Friedberg M, Saffran B, Stinson TJ, et al: Evaluation of conflict of interest in economic analyses of new drugs used in oncology. JAMA 282: 1453-1457, 1999
22. Marshall E: Biomedical ethics: Penn report, agency heads home in on clinical research. Science 288:1558-1559, 2000
23. Steinbrook R: Protecting research subjects: The crisis at Johns Hopkins. N Engl J Med 346:716-720, 2002
24. Thompson T: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. Rockville, MD, Department of Health and Human Services, 2004
25. Morin K, Rakatansky H, Riddick FA Jr, et al: Managing conflicts of interest in the conduct of clinical trials. JAMA 287:78-84, 2002
26. American Society of Clinical Oncology: Revised conflict of interest policy. J Clin Oncol 21: 2394-2396, 2003
27. National Institutes of Health: Report of the National Institutes of Health Blue Ribbon Panel on Conflict of Interest Policies: A Working Group of the Advisory Committee to the Director. Bethesda, MD, National Institutes of Health, 2004
28. Travis K: NIH adopts strict conflict-of-interest policies for all employees. J Natl Cancer Inst 97:337, 2005
29. US Department of Health and Human Services: Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Special Advisory Committees. Bethesda, MD, US Department of Health and Human Services, Food and Drug Administration, January 2002
30. Supplemental Standards of Ethical Conduct and Disclosure Requirements for Employees of the Department of Health and Human Services, 5 CFR §§5501-5502, Federal Register, February 3, 2005
31. General Accounting Office: Biomedical Research, HHS Direction Needed to Address Financial Conflicts of Interest, GAO-02-89. Rockville, MD, Department of Health and Human Services, 2001. http://www.aau.edu/research/gao.pdf
32. 21 CFR 54, 2000. http://www.access.gpo .gov/nara/cfr/waisidx_00/ 21cfr54_00.html
33. Shalala D: Protecting research subjects: What must be done. N Engl J Med 343:808-810, 2000
34. McCrary SV, Anderson CB, Jakovljevic J, et al: A national survey of policies on disclosure of conflicts of interest in biomedical research. N Engl J Med 343:1621-1626, 2000
35. Lo B, Wolf LE, Berkeley A: Conflict-of-interest policies for investigators in clinical trials. N Engl J Med 343:1616-1620, 2000
36. Boyd EA, Cho MK, Bero LA: Financial conflict-of-interest policies in clinical research: Issues for clinical investigators. Acad Med 78:769-774, 2003
37. Miller TE, Sage WM: Disclosing physician financial incentives. JAMA 281:1424-1430, 1999
38. Resnik DB: Disclosing conflicts of interest to research subjects: An ethical and legal analysis. Account Res 11:141-159, 2004
39. Weinfurt KP, Dinan MA, Allsbrook JS, et al: Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants. Acad Med 81:113-118, 2006
40. Kim SY, Millard RW, Nisbet P, et al: Potential research participants' views regarding researcher and institutional financial conflicts of interest. J Med Ethics 30:73-79, 2004
41. Hampson LA, Agrawal M, Joffe S, et al: Patients' views on financial conflicts of interest in cancer research trials. N Engl J Med 355:2330-2337, 2006
42. Daugherty CK: Impact of therapeutic research on informed consent and the ethics of clinical trials: A medical oncology perspective. J Clin Oncol 17: 1601-1617, 1999
43. Ford BM, Evans JS, Stoffel EM, et al: Factors associated with enrollment in cancer genetics research. Cancer Epidemiol Biomarkers Prev 15:1355-1359, 2006
44. Brawley OW: The study of accrual to clinical trials: Can we learn from studying who enters our studies? J Clin Oncol 22:2039-2040, 2004
45. Lara PN Jr, Higdon R, Lim N, et al: Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. J Clin Oncol 19:1728-1733, 2001
46. Cassileth BR: Clinical trials: Time for action. J Clin Oncol 21:765-766, 2003
47. Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291:2720-2726, 2004
48. Sateren WB, Trimble EL, Abrams J, et al: How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 20:2109-2117, 2002
49. Lewis JH, Kilgore ML, Goldman DP, et al: Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 21:1383-1389, 2003
50. Comis RL, Miller JD, Aldige CR, et al: Public attitudes toward participation in cancer clinical trials. J Clin Oncol 21:830-835, 2003
51. Markman M, Petersen J, Montgomery R: Influence of tumor type, disease status, and patient age on self-reported interest regarding participation in cancer clinical trials. Cancer 107:849-853, 2006
52. Ellis PM, Butow PN, Tattersall MH, et al: Randomized clinical trials in oncology: Understanding and attitudes predict willingness to participate. J Clin Oncol 19:3554-3561, 2001