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Empirical Assessment of Whether Moderate Payments Are Undue or Unjust Inducements for Participation in Clinical Trials
Scott D. Halpern, MD, PhD;
Jason H. T. Karlawish, MD;
David Casarett, MD, MA;
Jesse A. Berlin, ScD;
David A. Asch, MD, MBA
Arch Intern Med. 2004;164:801-803.
Background Paying patients to participate in clinical trials is ethically controversial. However, there has been no empirical documentation regarding whether payment represents an undue or unjust inducement.
Methods To evaluate these questions, we described hypothetical placebo-controlled trials of a new antihypertensive drug to 126 patients with mild-to-moderate hypertension recruited from hypertension and general medicine clinics at a university hospital. Using a 3 x 3, within-subjects design, we altered a risk to participation (either adverse effect rate or rate of randomization to placebo) and the payment participants would receive ($100, $1000, and $2000) and asked patients to indicate their willingness to participate (WTP) in each trial using a 6-point scale.
Results Clustered ordinal logistic regression models revealed that patients' WTP decreased with higher risk of adverse effects (P<.001), higher risk of being assigned to placebo (P = .02), and lower payment level (P<.001). There were no significant interactions between payment level and either risk variable, suggesting that increasing payments do not alter peoples' perceptions of risk. There was a trend toward a positive interaction between income and the influence of payment on WTP (P = .09), suggesting that payment more strongly influences WTP among wealthier people. Wealthier patients were more likely to state that payment was important in their participation decision (37% vs 20%, P = .05).
Conclusion Although higher payment motivates research participation, we found no evidence that commonly used payment levels represent undue or unjust inducements.
From the Department of Medicine (Drs Halpern, Karlawish, Casarett, and Asch), Centers for Clinical Epidemiology and Biostatistics (Drs Halpern, Asch, and Berlin), Bioethics (Drs Halpern, Karlawish, Casarett, and Asch), and Education and Research on Therapeutics (Drs Halpern and Berlin), and Leonard Davis Institute of Health Economics (Drs Karlawish, Casarett, and Asch), University of Pennsylvania School of Medicine, and Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (Drs Casarett and Asch), Philadelphia. The authors have no relevant financial interest in this article.
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