Performance Improvement 2001. Costs of Clinical Trials Study


The Cost of Cancer Trials Study (CCTS) is a study of cancer patients throughout the U.S. being conducted by RAND, a private, non-profit research institution based in Santa Monica, California, with principal funding and scientific guidance from the National Cancer Institute (NCI). This study will estimate the incremental costs of medical treatment provided as part of NCI-sponsored protocols. Incremental costs refers to the costs of additional medical resources, if any, provided to patients on protocols above and beyond those that would have been received in the absence of trial participation. The results from this study should be of interest to policymakers, insurers and healthcare decision makers trying to determine appropriate reimbursement for clinical trials. As secondary endpoints, patient satisfaction and health outcomes of patients in trials will be compared with those not in trials. The study will use a multi-stage study design to select 1,600 patients at 50-60 study sites among all of the institutions, clinics or practices in the U.S. that are participating in NCI-sponsored Phase II or III clinical trials. The patient sample will be obtained by randomly selecting patients who have enrolled in a clinical trial during a specified period of time at these study sites. Using cancer registries and chart reviews, a matched control group of cancer patients who did not enroll in a clinical trial will be sampled and followed. Using economic models of costs, the two groups will be compared to estimate the cost of trial participation.


AGENCY SPONSOR: National Cancer Institute

FEDERAL CONTACT: Mary S. McCabe, 301-496-6404

PIC ID: 7116

PERFORMER: Rand Corporation, Santa Monica, CA