IMPACT OF CLINICAL-TRIAL PROTOCOLS ON PATIENT-CARE SYSTEMS AT THE UNIVERSITY-OF-TEXAS-MD-ANDERSON-CANCER-CENTER

Clinical trial protocols represent a significant component of the rese arch program at the University of Texas M.D. Anderson Cancer Center. C urrently, there are nearly 800 active protocols using more than 150 in vestigational drugs. Sponsors of these trials include the National Can cer Institute, numerous pharmaceutical companies, and a variety of oth er funding sources. Because of our large patient base, however, routin e participation in cooperative groups is limited. The impact of clinic al trial protocols on patient care systems is a growing concern that i s addressed primarily by the Surveillance Committee at M.D. Anderson. Like many institutional review boards, this committee reviews all prot ocols and must grant approval before the activation of any clinical tr ial. The issues of medical ethics, including a risk-benefit assessment for research subjects, equitable patient selection, safeguards for ec onomically disadvantaged populations, and the general requirements for informed consent, also fall under the purview of this board. For any comprehensive cancer center to succeed, it must have strong research p rograms that enhance treatment options for patients. The crisis in fin ancing health care significantly threatens the viability of cancer res earch. Reimbursement for the related costs of individuals participatin g in clinical trials has become a battle ground for third-party payers . The resulting economic risk is shared by health care providers and p atients. As a consequence, many cancer centers, including M.D. Anderso n, have initiated an economic-impact analysis for protocols as a compo nent of the review process. This analysis includes an estimation of th e patient care costs compared to the funding allocated to support the research. Future research will include pharmacoeconomic analysis and o ther ways to relate the costs and outcomes of treatment protocols. In the interim, we must monitor reimbursement trends for patients enrolle d in clinical trials closely and amend the informed consent process to include a discussion of potential economic risk or hardship to patien ts if insurance claims are denied. Cancer care providers, third-party payers, the federal government, and society at large must work togethe r to address the funding of cancer research and patient care.