Cancer Patient Care in Clinical Trials Sponsored by the National Cancer Institute: What Does It Cost?

“What does it cost?” This has been the refrain reiterated with increasing intensity over the last decade on the issue of financial coverage of patient care for patient's enrolled in clinical trials sponsored by the National Cancer Institute (NCI). In the past, the answer to this question, to the frustration of health care payers and providers, has been, “We don't know.” In recent years, the financial coverage of patient care in clinical trials has become an urgent question because implicit subsidies available for support of clinical research in the past have been suppressed by various measures aimed at achieving global health care cost containment (1). The NCI, through its Office of Clinical Research Promotion, has been in the forefront of addressing this problem by negotiating agreements in principle and in practice with such organizations as Medicare and the American Association of Health Plans for coverage of patient care in clinical trials sponsored by the National Institutes of Health (NIH) (2). Legislation mandating coverage of patient care costs for specific cancer clinical trials has been enacted in Maryland, Rhode Island, and Georgia (3) and is under consideration in several other states. A similar mandate is also under consideration at the federal level as part of the proposed Patient's Bill of Rights Act of 1998 (4).