Expectations of benefit in early-phase clinical trials: Implications for assessing the adequacy of informed consent

Medical Decision Making

Volumn 28, Issue 4, 2008, Pages 575-581

  Weinfurt, Kevin P ^a,b   Seils, Damon M ^a   Tzeng, Janice P ^a   Compton, Kate L ^a   Sulmasy, Daniel P ^c,d   Astrow, Alan B ^e   Solarino, Nicholas A ^f   Schulman, Kevin A ^a,b   Meropol, Neal J ^f  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c St Vincent's Manhattan   (United States)

^d NEW YORK MEDICAL COLLEGE   (United States)

^e MAIMONIDES MEDICAL CENTER   (United States)

^f FOX CHASE CANCER CENTER   (United States)

Author keywords

Clinical trials; Communication; Comprehension; Decision making; Informed consent; Phase 1; Phase 2

Indexed keywords

ADULT; ARTICLE; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; COMPREHENSION; DEMOGRAPHY; EXPECTATION; FEMALE; HUMAN; INFORMED CONSENT; MALE; MEDICAL DECISION MAKING; PATIENT ATTITUDE; PATIENT PARTICIPATION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; SEMI STRUCTURED INTERVIEW; UNITED STATES; UNIVERSITY HOSPITAL;

CLINICAL TRIALS AS TOPIC; COMPREHENSION; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; NEOPLASMS;

EID: 47249134621     PISSN: 0272989X     EISSN: 1552681X     Source Type: Journal    
DOI: 10.1177/0272989X08315242     Document Type: Article

References (19)

1. Agrawal M., Emanuel EJ Ethics of phase 1 oncology studies: reexamining the arguments and the data. JAMA. 2003 ; 290: 1075-82.
2. Menikoff J. Consent forms for oncology trials. N Engl J Med. 2003 ; 348: 1496-7.
3. King NM, Henderson GE, Churchill LR, et al. Consent forms and the therapeutic misconception. IRB. 2005 ; 27: 1-8.
4. Henderson GE, Easter MM, Zimmer C., et al. Therapeutic misconception in early phase gene transfer trials. Soc Sci Med. 2006 ; 62: 239-53.
5. Horng S., Emanuel EJ, Wilfond B., Rackoff J., Martz K., Grady C. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med. 2002 ; 347: 2134-40.
6. Cheng JD, Hitt J., Koczwara B., et al. Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol. 2000 ; 18: 421-8.
7. Meropol NJ, Weinfurt KP, Burnett CB, et al. Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol. 2003 ; 21: 2589-96.
8. Daugherty C., Ratain MJ, Grochowski E., et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995 ; 13: 1062-72.
9. Cox AC, Fallowfield LJ, Jenkins VA Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer. 2006 ; 14: 303-9.
10. Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth. 2003 ; 24: 329-44.
11. Horng S., Grady C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB. 2003 ; 25: 11-6.
12. Weinfurt KP, Castel LD, Li Y., et al. The correlation between patient characteristics and expectations of benefit from phase I clinical trials. Cancer. 2003 ; 98: 166-75.
13. Weinfurt KP Discursive versus information-processing perspectives on a bioethical problem: the case of ''unrealistic'' expectations. Theory Psychol. 2004 ; 14: 191-203.
14. Willis GB Cognitive Interviewing. Thousand Oaks (CA): Sage ; 2005.
15. Hacking I. The Emergence of Probability. Cambridge (UK): Cambridge University Press ; 1975.
16. Alicke MD, Klotz ML Personal contact, individuation, and the better-than-average effect. J Pers Soc Psychol. 1995 ; 68: 804-25.
17. Kahneman D., Tversky A. Variants of uncertainty. In: Kahneman D, Slovic P, Tversky A, eds. Judgment under Uncertainty: Heuristics and Biases. New York: Cambridge University Press ; 1982. p 509-20.
18. Ehrenreich B. Welcome to Cancerland. Harpers (N Y N Y). 2001 ; 303 (1818). 43 - 53.
19. Zaslow J. Cancer thriver: a shorter road with many miles to bicycle. Wall Street Journal, 5 April 2007: D1.