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ABSTRACT: Strategies to overcome clinical, regulatory, and financial challenges in the implementation of personalized medicine.

This article highlights major developments over the last decade in personalized medicine in cancer. Emerging data from clinical studies demonstrate that the use of targeted agents in patients with targetable molecular aberrations improves clinical outcomes. Despite a surge of studies, however, significant gaps in knowledge remain, especially in identifying driver molecular aberrations in patients with multiple aberrations, understanding molecular networks that control carcinogenesis and metastasis, and most importantly, discovering effective targeted agents. Implementation of personalized medicine requires continued scientific and technological breakthroughs; standardization of tumor tissue acquisition and molecular testing; changes in oncology practice and regulatory standards for drug and device access and approval; modification of reimbursement policies by health care payers; and innovative ways to collect and analyze electronic patient information that are linked to prospective clinical registries and rapid learning systems. Informatics systems that integrate clinical, laboratory, radiologic, molecular, and economic data will improve clinical care and will provide infrastructure to enable clinical research. The initiative of the EurocanPlatform aims to overcome the challenges of implementing personalized medicine in Europe by sharing patients, biologic materials, and technological resources across borders. The EurocanPlatform establishes a complete translational cancer research program covering the drug development process and strengthening collaborations among academic centers, pharmaceutical companies, regulatory authorities, health technology assessment organizations, and health care systems. The CancerLinQ rapid learning system being developed by ASCO has the potential to revolutionize how all stakeholders in the cancer community assemble and use information obtained from patients treated in real-world settings to guide clinical practice, regulatory decisions, and health care payment policy.

via Strategies to overcome clinical,… [Am Soc Clin Oncol Educ Book. 2013] – PubMed – NCBI.

Written by

Brian is a research scientist and educational technologist. He helped transform Pfizer’s Medical Education Group and previously served in educational leadership roles at HealthAnswers, Inc.; Acumentis, LLC.; Cephalon; and Wyeth. He taught graduate medical education programs at Arcadia University for 10 years. Dr. McGowan recently authored the book "#socialQI: Simple Solutions for Improving Your Healthcare" and has been invited to speak internationally on the subject of information flow, technology, and learning in healthcare.

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