Learning from our patients: One participant's impact on clinical trial research and informed consent

Annals of Internal Medicine

Volumn 126, Issue 11, 1997, Pages 892-897

  Daugherty, Christopher K ^a,b   Siegler, Mark ^a,b   Ratain, Mark J ^a   Zimmer, George ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CLINICAL PROTOCOL; CLINICAL TRIAL; HUMAN; HUMAN CELL; INFORMED CONSENT; LEARNING; MEDICAL RESEARCH; PRIORITY JOURNAL; REVIEW;

EID: 0030990804     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-126-11-199706010-00008     Document Type: Review

References (28)

1. National Commission for thé Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 3 volumes. Washington. DC: USGPO; 1978. DHEW publication no. (OS) 78-0012/G.
2. Levine RJ. Ethics and Regulation of Clinical Research. 2d ed. Baltimore: Urban and Schwarzenburg; 1986.
3. Jonas H. Philosophical reflections on experimenting with human subjects. In: Freund PA, ed. Experimentation with Human Subjects. New York: Braziller; 1970.
4. Faden RR, Beauchamp TU King NM. A History and Theory of Informed Consent. New York: Oxford Univ Pr; 1986.
5. Arno PS, Feiden K. Against the Odds: The Story of AIDS Drug Development, Politics, and Profits. New York: HarperCollins; 1992.
6. Edgar H. Rothman DJ. New rules for new drugs: the challenge of AIDS to the regulatory process. Milbank Q. 1990:68:111-42.
7. Wächter RM. AIDS, activism, and the politics of health. N Engl J Med. 1992;326:128-33.
8. Code of Federal Regulations. Title 21; Part 314, Subpart H; December 11, 1992.
9. Cotton P. FDA "pushing envelope" on AIDS drug. JAMA. 1991:266:757-8.
10. Steele F. AIDS drugs lurch towards market. Nat Med. 1995;1:285-6.
11. Carter SK. Clinical research and drug development of antivirals in HIV: an industry perspective. J Acquir Immune Defic Syndr Hum Retrovirol. 1995; 10(Suppl2):S107-13.
12. Carpenter CC, Fischl MA, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, et al. Antiretroviral therapy for HIV infection in 1996. Recommendations of an international panel. International AIDS SocietyUSA. JAMA. 1996:276:146-54.
13. Levine RJ. The impact of HIV infection on society's perception of clinical trials. Kennedy Institute of Ethics Journal 1994;4:93-8.
14. Mclntosh H. AIDS lobby earns respect from cancer leaders. J Natl Cancer Inst. 1990;82:730-2.
15. Flintor L. Patient activism: cancer groups become vocal and politically active. J Natl Cancer Inst. 1991;83:528-9.
16. Langer AS. The politics of breast cancer. J Am Med Worn Assoc. 1992;47: 207-9.
17. Stout H, McGinley L. Cancer drugs to get speedier FDA review. The Wall Street Journal. 29 March 1996;B1.
18. Rothenberg ML, Eckardt JR, Kahn JG, et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol. 1996;14:1128-35.
19. Transcripts from Oncology Drug Advisory Commission meeting. June 13, 1996.
20. DeVita VT. Principles of chemotherapy. In: DeVita VT, Hellman S, Rosenberg SA, eds. Principles and Practice of Oncology. 4th ed. 2 volumes. Philadelphia: Lippincott; 1993:276-92.
21. Ratain MJ, Mick R, Schilsky R, 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.
22. Decoster G, Stein G, Holdener EE. Responses and toxic deaths in phase I clinical trials. Ann Oncol. 1990:1:175-81.
23. Von Hoff DD, Turner J. Response rates, duration of response, and dose response effects in phase I studies of antineoplastics. Invest New Drugs. 1991;9: 115-22.
24. Daugherty C. Ratain MJ, Grochowski E, Stocking C. Kodish E, Mick R, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995;13:1062-72.
25. Daugherty C, Lyman K, Mick R, Siegler M, Ratain MJ. Differences in perceptions and goals, expectations, and level of informed consent in phase I clinical trials [Abstract]. Proc Am Soc Clin Oncol. 1996;15:A1713.
26. Daugherty C, Siegler M, Ratain MJ, et al. A feasibility study of informed consent of medical decision making employing an interactive patient choice design in phase I trials [Abstract]. Proc Am Soc Clin Oncol. 1996;15:A352.
27. Gotay CC. Accrual to cancer clinical trials: directions from the research literature. Soc Sei Med. 1991:33:569-77.
28. Viability of cancer clinical research: patient accrual, coverage, and reimbursement. American Medical Association Council on Scientific Affairs. J Natl Cancer Inst. 1991:83:254-9.