Clinical trials. Access and reimbursement.

Clinical trials continue to play an extremely important role in clinical oncology, but of the nearly 1 million cancer patients diagnosed in the United States each year, only 2.5% (25,000) participate in such trials. Access to clinical trials has been enhanced by the adoption by the NCI of a promotional campaign that involves seminars, dissemination of information to national and local news media, and assisting in making information about clinical trials available to patients and physicians. Factors that hinder accrual of patients to clinical trials include: (1) physicians' concern about losing contact with patients, (2) physicians who feel that "experimental therapy" is not as good as "standard therapy," and (3) the time it takes to discuss and implement clinical trials. Reimbursement for clinical trials has also become a major concern. Who should pay for clinical research? Many insurance companies have been reluctant to pay for "experimental therapy" but will pay for "standard therapy." If this trend continues, the whole concept and organization of clinical trials, i.e., Phase I, II, and III trials, will be greatly hindered. Solutions must be found, and third party payers need to realize that an investment in clinical trials today will decrease the long term costs of state-of-the-art care.