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Expectations of Benefit in Early-Phase Clinical Trials: Implications for Assessing the Adequacy of Informed Consent

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, kevin.weinfurt{at}duke.edu, Departments of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina

Damon M. Seils, MA

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Janice P. Tzeng, BSPH

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Kate L. Compton, BA

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Daniel P. Sulmasy, OFM, MD, PhD

The John J. Conley Department of Ethics, St. Vincents Manhattan, New York, New York, Bioethics Institute of New York Medical College, Valhalla, New York

Alan B. Astrow, MD

Maimonides Medical Center, Brooklyn, New York

Nicholas A. Solarino, MS

Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia, Pennsylvania

Kevin A. Schulman, MD

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Departments of Psychiatry and Behavioral Sciences and Medicine, Duke University School of Medicine, Durham, North Carolina

Neal J. Meropol, MD

Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia, Pennsylvania

Background. Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit. Methods. Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions. Results. Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P=0:02). The most common justifications involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower ( < 50%) expectations (n = 3 [27%]). Conclusions. The wording of questions about likelihood of benefit shapes the expectations that patients express. Patients who express high expectations may not do so to communicate understanding but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding.

Key Words: clinical trials • phase 1 • clinical trials • phase 2 • communication • comprehension • decision making • informed consent.

This version was published on July 1, 2008

Medical Decision Making, Vol. 28, No. 4, 575-581 (2008)
DOI: 10.1177/0272989X08315242


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