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Executive Summary

The National Cancer Institute has asked the Blue Cross/Blue Shield Association to conduct a pilot study to assess the costs and feasibility of reimbursing certain cancer clinical trials. Blue Cross/Blue Shield says it is holding "very preliminary discussions" about the possibility of conducting such a study. The association is also beginning to develop a policy paper on the issues of clinical trials and reimbursement. An NCI report, entitled "Remedies and Costs of Difficulties Hampering Clinical Research," notes that one of the primary obstacles to clinical research is the reluctance of some third-party payors to reimburse for care associated with experimental therapies. The NCI report was requested by the Senate Appropriations Committee in its FY 1989 budget report. A large retrospective study of the relative costs of investigational and standard therapy has already been conducted by the National Center for Health Services Research in collaboration with the NCI. The study collected data from patient records from all major cancer centers in the U.S. from 1980-1985. NCI noted that researchers have recently completed data collection and the project is in the early stages of analysis. NCI expects an analysis of the data to be completed in six-to-eight months. The NCI report also points to a second obstacle to clinical research -- suboptimal accrual rates to clinical trials. NCI reports that slow patient recruitment has frequently added a lag time of up to several years to a study. For example, the report states that three major cooperative groups whose performance was recently analyzed "had accrual rates that would extend the average duration of studies by 32%, 113% and 119% compared to the originally projected durations." NCI-supported clinical cooperative groups currently have about 25,000 patients in treatment trials. NCI said its goal is to double this number to 50,000 by the year 1992. As part of its effort to achieve this goal, NCI has asked its clinical trials groups to "increase substantially the percentage of eligible patients placed on study." In addition, NCI has asked institute-supported clinical cooperative groups to decrease the complexity of studies, eliminate the collection of nonessential data and minimize the number of medical tests conducted. The report also notes that "some investigators are exploring the use of videotapes to explain protocols and facilitate the informed consent process." NCI is also trying to boost patient accrual by designating certain trials as "high priority." Specifically, NCI explained, "we have developed a process by which certain key clinical trials may be designated as having 'high priority' for supplemental funding, so that the cooperative groups can recruit currently unaffiliated physicians as additional participants." To date, NCI has selected five trials in the areas of colon and rectum cancer, bladder cancer, and the intermediate and aggressive non-Hodgkin's lymphomas as high priority. NCI has also held preliminary discussions with representatives from several health maintenance organizations, many of which "have expressed an interest in introducing the clinical trials process into their HMOs or expanding their existing efforts," the report says. "Along these lines," NCI added, "we have discussions underway with officials of the Department of Veterans Affairs, Kaiser Permanente and Humana concerning links with the NCI's clinical trials program."

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