1 . Barrie R. Cassileth, Edward J. Lusk, David S. Miller, and Shelley Hurwitz, "Attitudes Toward Clinical Trials Among Patients and the Public," Journal of the American Medical Association 248, no. 8 (1982): 968-970; and Christopher Daugherty, Mark J. Ratain, Eugene Grocowski et al., "Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials," Journal of Clinical Oncology 13, no. 5 (1995): 1062-1072.
2 . Ira S. Ockene et al., "The Consent Process in the Thrombolysis in Myocardial Infarction (TIMI--Phase I) Trial," Clinical Research 39 no. 1 (1991): 13-17; Roberta M. Tanakanow, Burgunda V. Sweet, and Jill A. Weiskopf, "Patients' Perceived Understanding of Informed Consent in Investigational Drug Studies," American Journal of Hospital Pharmacy 49 (1992): 633-635; Doris T. Penman et al., "Informed Consent for Investigational Chemotherapy: Patients' and Physicians' Perceptions," Journal of Clinical Oncology 2 no.7 (1984): 849-855; Henry W. Riecken and Ruth Ravich, "Informed Consent to Biomedical Research in Veterans Administration Hospitals," Journal of the American Medical Association 248 no. 3 (1982): 344-348; Gail A. Bujorian, "Clinical Trials: Patient Issues in the Decision-Making Process," Oncology Nursing Forum 15, no. 6 (1988): 779-783; Niels Lynoe et al., "Informed Consent: Study of Quality of Information Given to Participants in a Clinical Study," British Medical Journal 303 (1991): 610-613; and Daugherty et al., "Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials."
3 . D. D. Von Hoff and J. Turner, "Response Rates, Duration of Response, and Dose Response Effects in Phase I Studies of Antineoplastics," Investigational New Drugs 9 (1991): 115-122; E. Estey et al., "Therapeutic Response in Phase I Trials of Antineoplastic Agents," Cancer Treatment Report 70 (1986): 1105-1155; and G. Decoster, G. Stein, and E. E. Holdener, "Responses and Toxic Deaths in Phase I Clinical Trials," Annals of Oncology 2 (1990): 175-181.
4 . Decoster, Stein, and Holdener, "Responses and Toxic Deaths in Phase I Clinical Trials," 175-181.
5 . There have been very few occasions reported in the literature of Phase I trials having medical benefit for patient-subjects. While very rare, that such benefit occurs at all further complicates the difficulty over what to say to patients at the end of the medical road who are considering enrolling in a Phase I trial. See, for example, M. Kaminski, "Radioimmunotherapy of Bcell Lymphoma with I-131 Anti-B1," New England Journal of Medicine 329, no. 7 (1993): 459-465.
6 . Daugherty et al., "Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials."
7 . Paul S. Appelbaum, Loren H. Roth, and Charles Lidz, "The Therapeutic Misconception: Informed Consent in Psychiatric Research," International Journal of Law and Psychiatry 5 (1982): 319-329; Paul S. Appelbaum et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconception," Hastings Center Report, April 1987, 20-24.
8 . Decoster, Stein, and Holdener, "Responses and Toxic Deaths in Phase I Clinical Trials."
9 . Cassileth et al., "Attitudes toward Clinical Trials among Patients and the Public"; Susan M. Newburg, Anne E. Holland, and Lesly A. Pearce, "Motivation of Subjects to Participate in a Research Trial," Applied Nursing Research 5, no. 2 (1992): 89-104; Penman et al., "Informed Consent for Investigational Chemotherapy: Patients' and Physicians' Perceptions"; and Daugherty et al., "Perceptions of Cancer Patients and their Physicians Involved in Phase I Trials."
10 . Nancy M. P. King, "Experimental Treatment: Oxymoron or Aspiration?" Hastings Center Report 25, no. 4 (1995): 6-15; Jay Katz, "The Regulation of Human Experimentation in the United States--A Personal Odyssey," IRB 9, no. 1 (1987): 1, 5-6; and J. R. Maltby, and C. J. Eagle, "Patient Recruitment for Clinical Research [letter, comment]," Canadian Journal of Anaesthesia 40, no. 9 (1993): 897-898.
11 . Ockene et al., "The Consent Process in the Thrombolysis in Myocardial Infarction (TIMI--Phase I) Trial"; Tanakanow et al., "Patients' Perceived Understanding of Informed Consent in Investigational Drug Studies"; Penman et al., "Informed Consent for Investigational Chemotherapy: Patients' and Physicians' Perceptions"; Riecken et al., "Informed Consent to Biomedical Research in Veterans Administration Hospitals"; Bujorian et al., "Clinical Trials: Patient Issues in the Decision-Making Process"; Lynoe et al., "Informed Consent: Study of Quality of Information Given to Participants in a Clinical Study"; and Daugherty et al., "Perceptions of Cancer Patients and their Physicians Involved in Phase I Trials."
12 . King, "Experimental Treatment: Oxymoron or Aspiration?"
13 . Riecken et al., "Informed Consent to Biomedical Research in Veterans Administration Hospitals."
14 . King, "Experimental Treatment: Oxymoron or Aspiration?"
Last modified: 06/11/96 14:30