Summary

During 2 lively days of discussion, it became apparent that predictive tests that enable cancer treatments to be tailored to the highly specific biochemical abnormalities that underlie a tumor, rather than to the more general pathology, hold great promise for making cancer therapy more safe and effective. These tests can be more predictive of treatment response than standard clinical prognostics, and have already become part of standard clinical practice for some cancers and cancer drugs. However, in order to realize the promise of personalized cancer medicine, a number of obstacles need to be overcome, including technological, regulatory, and reimbursement hurdles.

On the technological side, speakers and participants noted that the research community needs to improve its understanding of genetic pathways and how predictive tests work. It also needs to develop superior methods of predictive test validation, improve test reliability, and advance how predictive tests are used in clinical decision making. In addition, methods for codeveloping biomarkers concurrently with targeted drugs need improvement.

Many workshop participants expressed concern about the disparities in the regulation of laboratory-developed tests and FDA-approved tests. This lack of a well-defined process for biomarker development, validation, qualification, and use has reduced interest and investment in developing predictive tests. Speakers and participants suggested that the regulatory system needs to be dynamic and able to adapt to rapid changes in technology.



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Summary D uring 2 lively days of discussion, it became apparent that pre- dictive tests that enable cancer treatments to be tailored to the highly specific biochemical abnormalities that underlie a tumor, rather than to the more general pathology, hold great promise for making cancer therapy more safe and effective. These tests can be more predictive of treatment response than standard clinical prognostics, and have already become part of standard clinical practice for some cancers and cancer drugs. However, in order to realize the promise of personalized cancer medicine, a number of obstacles need to be overcome, including technological, regula- tory, and reimbursement hurdles. On the technological side, speakers and participants noted that the research community needs to improve its understanding of genetic pathways and how predictive tests work. It also needs to develop superior methods of predictive test validation, improve test reliability, and advance how predictive tests are used in clinical decision making. In addition, methods for codeveloping biomarkers concurrently with targeted drugs need improvement. Many workshop participants expressed concern about the disparities in the regulation of laboratory-developed tests and FDA-approved tests. This lack of a well-defined process for biomarker development, validation, quali- fication, and use has reduced interest and investment in developing predic- tive tests. Speakers and participants suggested that the regulatory system needs to be dynamic and able to adapt to rapid changes in technology. 

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 PERSONALIZED MEDICINE IN ONCOLOGY Finally, speakers and participants proposed that the reimbursement sys- tem needs to be adjusted to reward the development and use of high-quality predictive tests. The current reimbursement system of coding, bundling of payments, and using a fixed-fee schedule for predictive tests discourages test innovation; does not adequately recognize the clinical importance of predic- tive tests; and is not value based. An IOM committee will examine these issues further, and develop consensus-based recommendations for moving the field of personalized medicine forward.