Research participants' high expectations of benefit in early-phase oncology trials: Are we asking the right question?

Journal of Clinical Oncology

Volumn 30, Issue 35, 2012, Pages 4396-4400

  Weinfurt, Kevin P ^a   Seils, Damon M ^a   Lin, Li ^a   Sulmasy, Daniel P ^b   Astrow, Alan B ^c   Hurwitz, Herbert I ^a   Cohen, Roger B ^d   Meropol, Neal J ^e  

^a DUKE UNIVERSITY   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c MAIMONIDES MEDICAL CENTER   (United States)

^d FOX CHASE CANCER CENTER   (United States)

^e UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CLINICAL RESEARCH; DEMOGRAPHY; EXPECTATION; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; ONCOLOGY; OPTIMISM; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RELIGION;

CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; NEOPLASMS; PHYSICIAN-PATIENT RELATIONS; RESEARCH DESIGN;

EID: 84870749935     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2011.40.6587     Document Type: Article

References (28)

1. Agrawal M, Emanuel EJ: Ethics of phase 1 oncology studies: Reexamining the arguments and data. JAMA 290:1075-1082, 2003 (Pubitemid 37430449)
2. Menikoff J: Consent forms for oncology trials. N Engl J Med 348:1496-1497, 2003; author reply 1496-1497
3. King NM, Henderson GE, Churchill LR, et al: Consent forms and the therapeutic misconception: The example of gene transfer research. IRB 27:1-8, 2005 (Pubitemid 41674175)
4. Henderson GE, Easter MM, Zimmer C, et al: Therapeutic misconception in early phase gene transfer trials. Soc Sci Med 62:239-253, 2006 (Pubitemid 41728121)
5. Horng S, Emanuel EJ, Wilfond B, et al: Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 347:2134-2140, 2002 (Pubitemid 36015126)
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 18:421-428, 2000 (Pubitemid 30056433)
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 21:2589-2596, 2003 (Pubitemid 46606342)
8. Horng S, Grady C: Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 25:11-16, 2003 (Pubitemid 41585063)
9. Miller FG, Joffe S: Benefit in phase 1 oncology trials: Therapeutic misconception or reasonable treatment option? Clin Trials 5:617-623, 2008
10. Weinfurt KP: Varieties of uncertainty and the validity of informed consent. Clin Trials 5:624-625, 2008; discussion 630
11. King NM: Defining and describing benefit appropriately in clinical trials. J Law Med Ethics 28: 332-343, 2000
12. Daugherty C, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072, 1995
13. Cox AC, Fallowfield LJ, Jenkins VA: Communication and informed consent in phase 1 trials: A review of the literature. Support Care Cancer 14: 303-309, 2006
14. Weinfurt KP, Sulmasy DP, Schulman KA, et al: Patient expectations of benefit from phase I clinical trials: Linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth 24:329-344, 2003 (Pubitemid 37336581)
15. Weinfurt KP, Seils DM, Tzeng JP, et al: Expectations of benefit in early-phase clinical trials: Implications for assessing the adequacy of informed consent. Med Decis Making 28:575-581, 2008 (Pubitemid 351990000)
16. Zikmund-Fisher BJ, Smith DM, Ubel PA, et al: Validation of the Subjective Numeracy Scale: Effects of low numeracy on comprehension of risk communications and utility elicitations. Med Decis Making 27:663-671, 2007 (Pubitemid 47547593)
17. Weinfurt KP, Depuy V, Castel LD, et al: Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials. Cancer 103:140-147, 2005 (Pubitemid 39665467)
18. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 93:139-147, 2001 (Pubitemid 32111992)
19. Scheier MF, Carver CS, Bridges MW: Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): A reevaluation of the Life Orientation Test. J Pers Soc Psychol 67:1063-1078, 1994
20. Underwood LG, Teresi JA: The daily spiritual experience scale: Development, theoretical description, reliability, exploratory factor analysis, and preliminary construct validity using health-related data. Ann Behav Med 24:22-33, 2002 (Pubitemid 34411386)
21. Fetzer Institute/National Institute on Aging: Multidimensional Measurement of Religiousness/ Spirituality for Use in Health Research. Kalamazoo, MI, Fetzer Institute, 1999
22. Goodman LA, Kruskal WH: Measures of Association for Cross Classifications. New York, NY, Springer-Verlag, 1979
23. Horstmann E, McCabe MS, Grochow L, et al: Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352:895-904, 2005 (Pubitemid 40300298)
24. Tversky A, Kahneman D: The framing of decisions and the psychology of choice. Science 211:453-458, 1981 (Pubitemid 11145313)
25. Hacking I: An Introduction to Probability and Inductive Logic. Cambridge, United Kingdom, Cambridge University Press, 2002
26. Sulmasy DP, Astrow AB, He MK, et al: The culture of faith and hope: Patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer 116:3702-3711, 2010
27. Jansen LA: The problem with optimism in clinical trials. IRB 28:13-19, 2006
28. Kim SY, Schrock L, Wilson RM, et al: An approach to evaluating the therapeutic misconception. IRB 31:7-14, 2009