Fourth, in our deliberations, many clinical questions were raised that are clearly in the purview of biomedical and clinical research, such as those relating to the appropriate physiologic variables in a staging index or to decisions to biopsy a patient following a positive screening mammogram. We do not believe that the program should try to tackle questions (such as these) that are best handled by prospective clinical RCTs. There are areas, however, where RCTs within the effectiveness arena might be considered. Among these might be alternative systems for delivering certain types of care for breast cancer, good mechanisms of feedback of practice-variation information to physicians, and ways to make information available to patients. We did not discuss these in any detail, but we encourage the agencies sponsoring effectiveness research to take them under advisement.

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