A major challenge to the adoption of personalized medicine approaches to diagnosis and treatment, using genomic information, is that the data required to address critical questions relevant to clinical applications, economics, policy, and regulatory issues are widely dispersed. An immediate concern is to identify the personalized medicine approaches that are now being used in clinical practice or are in advanced stages of development, and then to evaluate how those approaches came to be adopted, their apparent value to date, and what their impact has been. We have been developing and piloting a framework for the collection and synthesis of data related to personalized medicine with the goal of establishing an evidence base on technologies and research for translating research findings into clinical practice and policy. The Evidence Project will build on our pilot work with an emphasis on personalized medicine for colorectal and breast cancer. Our objective is to develop an evidence base on personalized medicine technologies, using genomics, for colorectal and breast cancer.
The Specific Aims are to:
Aim 1 : Identify, describe, and assess available data sources for the evidence base on colorectal and breast cancer personalized medicine interventions.
Aim 2 : Conduct case studies of personalized medicine technologies for colorectal and breast cancer that focus on clinical applications, economics, policy and regulatory issues and provide findings on key technologies and supplement detailed case studies with ongoing horizon scans of personalized medicine technology.
Aim 3 : Systematically review data needed for Program Projects: evaluations of clinical applications, including utilization data and studies of patients'and providers'preferences, and economic evaluations of personalized medicine Aim 4: Evaluate the policy implications of findings, including: what is known about personalized medicine innovations;how and why personalized medicine innovations get (or not get) to be adopted;and the potential or actual value and societal impact of personalized medicine innovations.
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