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Attitudes Toward Research Participation and Investigator Conflicts of Interest Among Advanced Cancer Patients Participating in Early Phase Clinical Trials

Stacy W. Gray, Fay J. Hlubocky, Mark J. Ratain, Christopher K. Daugherty

From the Section of Hematology/Oncology, Cancer Research Center, Committee on Clinical Pharmacology and Pharmacogenomics, and MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL

Address reprint requests to Christopher Daugherty, MD, The University of Chicago, MC 2115, 5841 S Maryland Ave, Chicago, IL 60637; email: cdaugher{at}medicine.bsd.uchicago.edu

Purpose: Although both financial and intrinsic conflicts of interest can exist throughout the drug development process, little is known about how advanced cancer patients enrolled onto early phase clinical trials perceive investigator conflicts of interests.

Patients and Methods: We interviewed 102 advanced cancer patients enrolled onto phase I clinical trials using a standardized survey that addressed multiple issues related to conflicts of interest and research participation.

Results: Fifty-five percent of patients would not be concerned if physicians involved in running a clinical trial had financial conflicts of interest, whereas 65% of patients would be concerned if physicians involved in running a trial had intrinsic conflicts of interest. Most patients reported that potential conflicts of interest should be disclosed to patients on research trials (52% for financial conflicts of interest and 61% for more intrinsic conflicts of interest). Most patients would be willing to participate in trials after learning conflict of interest information (63%). Younger patients expressed more concern regarding financial conflict of interest than older patients (odds ratio, 6.22; 95% CI, 1.41 to 27.24).

Conclusion: Patients with advanced cancer are equally, if not more, concerned about traditional intrinsic conflicts of interest as compared with financial conflicts of interest. Patients generally believed that conflict of interest information should be disclosed to research participants. The fact that younger patients expressed more concern about financial conflicts of interest may have the potential to influence clinical trial participation rates. The actual impact of conflict of interest disclosure to research subjects needs to be evaluated more carefully.

Supported by the National Institutes of Health Grant No. RO1 CA 087605-01A1 (C.K.D.).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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