Barriers to clinical trials. Part I: Reimbursement problems.

Most of the major clinical advancement in cancer treatment has been provided by cancer clinical trials. Approximately 60% of clinical trials are conducted in the community treatment setting and approximately 40% in academic and cancer centers. The cost of these trials are borne by a combination of third-party reimbursement for the cancer care and institution and research study support for the specific cost of the research trial. With the increasing emphasis on cost control, managed cancer care, and health care reform, there is evidence of increased resistance and even denial of third-party insurance carriers for the usual cancer care done in association with cancer clinical trials. If this issue is not specifically addressed in today's managed care environment or in proposed health care reform, there will be a severe barrier to future cancer clinical research and an associated decrease in the identification and evaluation of new and better cancer treatment.