Integration of breast MRI in clinical trials.

Clinical trials are the mechanism for implementing new treatment methods into clinical practice. A number of organizations have been developed to facilitate the initiation, implementation, and data analysis for clinical trials. Imaging is important for patient selection and establishment of endpoints, yet imaging expertise has been underrepresented in most clinical trial groups. The integration of breast MRI in clinical trials is an important step toward the establishment of this method of imaging in routine practice. In addition, these data will be important in justifying the expense of MRI to payer organizations. The potential roles of breast MRI in clinical trials are reviewed. These breast MRI applications are linked with some of the studies that are under development. It is important for the MRI community to be aware of the importance of clinical trials in the future clinical establishment of breast MRI. J. Magn. Reson. Imaging 2001;13:830-836.