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Clinical Trials: Are They a Good Buy?

From the Chicago Veterans Affairs Healthcare System/Lakeside Division; Robert H. Lurie Comprehensive Cancer Center; Division of Hematology/Oncology, Department of Medicine; and Institute for Health Services Research and Policy Studies, Northwestern University, Chicago, IL; Coalition of National Cancer Cooperative Groups, Philadelphia, PA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; and US Oncology, Inc, Houston, TX.

Address reprint requests to Charles L. Bennett, MD, PhD, Department of Veterans Affairs, Chicago Health Care System/Lakeside Division, 400 East Ontario St, Medical Sciences Research Bldg, Rm 205, Chicago, IL 60611; email: cbenne{at}northwestern.edu

PURPOSE: Concern that clinical trials may be too costly has been used to justify traditionally restrictive insurer policies regarding clinical trials. Additionally, fear of insurer reimbursement denial can be a significant barrier to clinical trial participation. In this study, we reviewed the empirical data on costs of clinical trials versus standard care and summarized the current status of policy initiatives related to clinical trial insurance reimbursement.

METHODS: Electronic and print data sources were searched for studies on the costs of oncology clinical trials. Information on policy initiatives for clinical trial reimbursement was obtained from the American Society of Clinical Oncology, the American Society of Hematology, and the Coalition of National Cancer Cooperative Groups and from searches of World Wide Web sites.

RESULTS: Five pilot studies provided information for 377 patients on phase II/III clinical trials matched with controls on standard care. Cost estimates ranged from 10% lower to 23% higher costs/charges for clinical trials in comparison to standard medical care. Medicare, 14 states, and several private insurers now cover the costs of patient care in "qualifying" clinical trials.

CONCLUSION: Findings from small pilot studies suggest that phase II and III clinical trials result in at most modest increases in cost over standard treatment costs. Also, an increasing number of policy makers have decided to support clinical trial reimbursement initiatives. It is hoped that economic data from large observational studies will facilitate widespread and permanent decisions that support reimbursement for phase I, II, and III clinical trial participation.

The opinions expressed herein are solely those of the authors and are not meant to represent those of the committees and departments at the American Society of Clinical Oncology or the American Society of Hematology, where some of the background information was obtained.

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