Special series on comparative effectiveness research: Challenges to real-world solutions to quality improvement in personalized medicine

Abstract

The laudatory visions of McShane and Hayes1 and Ginsburg and Kuderer2 for improvements in the quality and reporting of predictive/prognostic biomarker research - so crucial to the future of personalized medicine - sets an important agenda, but more effort is required to address real-world challenges for implementation. The QI effort for genomic medicine is itself challenged by real-world barriers to adoption of standards. To accelerate the quality agenda in genomic medicine we need to add to CER the insights and methodologies of health services research and the emerging fields of implementation science and knowledge translation. To this I would add the imperative of including policy analysis research to broaden our perspectives about how societal trends, attitudes, and changing values reflected in the notion of personalized medicine can influence the acceptability to all stakeholders of more rigorous evaluation standards and their consequences, especially if more rigorous evaluation is perceived by the public and by clinicians as counter to the availability of innovation earlier in the development cycle of an intervention. © 2012 by American Society of Clinical Oncology.