Inside information: Financial conflicts of interest for research subjects in early phase clinical trials

Journal of the National Cancer Institute

Volumn 96, Issue 9, 2004, Pages 656-661

  Helft, Paul R ^a,e   Ratain, Mark J ^b,c   Epstein, Richard A ^b,c,d   Siegler, Mark ^b,c  

^a Indiana University   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

^d STANFORD UNIVERSITY   (United States)

^e Division of Hematology and Oncology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; NEW DRUG;

ARTICLE; CANCER RESEARCH; CLINICAL STUDY; CLINICAL TRIAL; DOCTOR PATIENT RELATION; DRUG APPROVAL; DRUG RESEARCH; FINANCIAL MANAGEMENT; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICOLEGAL ASPECT; PRIORITY JOURNAL; CONFLICT OF INTEREST; DRUG INDUSTRY; ECONOMICS; ETHICS; INFORMATION DISSEMINATION; LEGAL ASPECT; PHASE 1 CLINICAL TRIAL; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; STANDARD; UNITED STATES;

CLINICAL TRIALS, PHASE I; CONFLICT OF INTEREST; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; ETHICS, RESEARCH; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; PHYSICIAN-PATIENT RELATIONS; RESEARCH SUBJECTS; RESEARCH SUPPORT; UNITED STATES;

EID: 2442536090     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/djh121     Document Type: Article

References (36)

1. Anand G, Smith R. Biotech analysts strive to peek inside clinical tests of drugs. The Wall Street Journal. Available at: http://online.wsj.com/article/ 0,,SB1028753930220142520.djm,00.html. [Last accessed: August 8, 2002.]
2. Angell M. Is academic medicine for sale? N Engl J Med 2000;342:1516-8.
3. Blumenthal D. Academic-industry relationships in the life sciences. Extent, consequences, and management. JAMA 1992;268:3344-9.
4. Blumenthal D, Campbell EG, Causino N, Louis KS. Participation of life-science faculty in research relationships with industry. N Engl J Med 1996;335:1734-9.
5. Blumenthal D. Ethics issues in academic-industry relationships in the life sciences: the continuing debate. Acad Med 1996;71:1291-6.
6. Blumenthal D, Causino N, Campbell E, Louis KS. Relationships between academic institutions and industry in the life sciences - an industry survey. N Engl J Med 1996;334:368-73.
7. Bodenheimer T. Uneasy alliance - clinical investigators and the pharmaceutical industry. N Engl J Med 2000;342:1539-44.
8. Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA 2000;284:2209-14.
9. Campbell EG, Louis KS, Blumenthal D. Looking a gift horse in the mouth: corporate gifts supporting life sciences research. JAMA 1998;279:995-9.
10. Cech TR, Leonard JS. Science and business. Conflicts of interest - moving beyond disclosure. Science 2001;291:989.
11. Cho MK, Shohara R, Schissel A, Rennie D. Policies on faculty conflicts of interest at US universities. JAMA 2000;284:2203-8.
12. Desk N. Conflict rules urged for doctor research. The New York Times 2001 Feb 8;Sect. A:21.
13. Friedberg M, Saffran B, Stinson TJ, Nelson W, Bennett CL. Evaluation of conflict of interest in economic analyses of new drugs used in oncology. JAMA 1999;282:1453-7.
14. Goldberg C. Medical schools offer rules on doctors' conflict of interest. The New York Times 2001 Feb 8;Sect. A:23.
15. Lo B, Wolf LE, Berkeley A. Conflict-of-interest policies for investigators in clinical trials. N Engl J Med 2000;343:1616-20.
16. Martin JB, Kasper DL. In whose best interest? Breaching the academic-industrial wall. N Engl J Med 2000;343:1646-9.
17. Press E, Washburn J. The kept university. The Atlantic Online. Available at: http://www.theatlantic.com/cgi-bin/o/issues/2000/03/press.htm. [Last accessed: January 29, 2001.]
18. Shalala D. Protecting research subjects - what must be done. N Engl J Med 2000;343:808-10.
19. Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329:573-6.
20. Van McCrary S, Anderson CB, Jakovljevic J, Khan T, McCullough LB, Wray NP, et al. A national survey of policies on disclosure of conflicts of interest in biomedical research. N Engl J Med 2000;343:1621-6.
21. Weatherall D. Academia and industry: increasingly uneasy bedfellows. Lancet 2000;355:1574.
22. Tector LM. Don't sell your research trials short. Association for Clinical Research Professionals. Available at: http://www.foley.com/FILES/ tbl_s31Publications%5CFileUpload137%5C1414%5Cresearchtrials.pdf. [Last accessed: December 12, 2003.]
23. Kass LR. Toward a more natural science: biology and human affairs. New York NY: The Free Press; 1985.
24. Ratain MJ, Mick R, Schilsky RL, Siegler M. Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 1993;85:1637-43.
25. Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10. Research ethics. CMAJ 1997;156:1153-7.
26. Witt MD, Gostin LO. Conflict of interest dilemmas in biomedical research. JAMA 1994;271:547-51.
27. Marwick C. Protecting subjects of clinical research. JAMA 1999;292: 516-7.
28. United States of America v. Dale J. Lange MD, Criminal Action No. 98-472-01. U.S. District Court for the Eastern District of Pennsylvania. 1999 U.S. Dist. LEXIS 4808.
29. Clark RC. Corporate law. Boston MA: Little, Brown and Company; 1986.
30. Pollack A, Johnston DC. Former chief of ImClone systems is charged with insider trading. The New York Times 2002 Jun 13;Sect. C:1.
31. Securities Exchange Act of 1934. Rule 10b-5. Available at: http:// www.law.uc.edu/CCL/34ActRls/rule10b-5.html. [Last accessed: March 15, 2004.]
32. Kleing WA, Coffee JC. Business organization and finance: legal and economic principles. 8th ed. New York NY: Foundation Press; 2002. p. 157-64.
33. Restatement Second of Torts § 538 [Rst 538(2)] 1977.
34. Epstein RA. Torts. Gaithersburg MD: Aspen Law & Business; 1999.
35. Basic, Inc. v. Levinson, 485 U.S. 224; 1988. Available at: http://laws.findlaw.com/us/485/224.html. [Last accessed: March 15, 2004.]
36. TSC Industries, Inc. v. Northway, Inc., 426 U.S. 438; 1976. Available at: http://laws.findlaw.com/us/426/438.html. [Last accessed: March 15, 2004.]