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Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary
The current state of the art of personalized medicine technology, including obstacles to its development and use by clinicians and patients.
The current approaches to test validation, including analytic validity, clinical validity, and clinical utility.
The regulation of personalized medicine technologies, including the approaches’ shortcomings.
Reimbursement hurdles that can hamper both the development and use of personalized medicine technologies.
Potential solutions to the technological, regulatory, and reimbursement obstacles to personalized medicine.
This document is a summary of the conference proceedings, which will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of personalized cancer medicine forward. The views expressed in this summary are those of the speakers and discussants, as attributed to them, and are not the consensus views of the participants of the workshop or of the members of the National Cancer Policy Forum.