The rapid development of genomic applications in the wake of the Human Genome Project creates both opportunities and challenges. While these tests may allow us to screen individuals for disease susceptibility and tailor prevention measures and treatments to maximize benefit and minimize harm, the swift pace of genomics research and lack of regulatory oversight mean that evidence on the utility of new tests is often lacking. The costs of genomic applications and resulting clinical interventions can be high, and in a policy environment increasingly focused on costs as well as effectiveness, information on clinical utility is critical. This project will address these challenges by establishing a Knowledge Synthesis (KS) Center in Genomics to synthesize evidence on established and emerging genetic tests, support translation of evidence into clinical and policy recommendations, and disseminate evidence summaries to decision-makers. Our proposal builds on the substantial experience of our investigative team at the Center for Health Research (CHR). We have been a member of the Oregon Evidence-Based Practice Center supporting the U.S. Preventive Services Task Force (USPSTF) for the past 10 years, directing a substantial segment of a Scientific Resource Center (SRC) that supports the activities of AHRQ's Effective Health Care (EHC) Program, and receiving ARRA funds to conduct comparative effectiveness research concentrating on prevention, behavioral interventions, and care delivery. Through ARRA funds, we are conducting an NCI-funded program on genomic applications in cancer (CERGEN). In our work for the USPSTF and others, we have prioritized and defined topics for review, developed and documented new review methods, and conducted both systematic and targeted reviews on a wide range of clinical topics. In partnership with the CDC and the EGAPP Working Group, we propose to:
Aim 1 : Establish a KS Center in Genomics to plan, conduct, and disseminate reviews of genomic evidence for diverse stakeholders in health care practice and policy.
Aim 2 : Conduct systematic evidence reviews for defined genomic research questions to support clinical decision-making and identify gaps in evidence requiring new research.
Aim 3 : Conduct and update targeted reviews on emerging applications and post topic briefs to GAPPNet.
Aim 4 : Develop novel methods for conducting evidence reviews, and document them in a Procedure Manual. The KS Center's products will be rapidly disseminated in the public domain through peer-reviewed publication, and internet postings. We will describe the state of evidence for specific applications, support clinical decision- makers in implementing effective care, and help to realize the promise of genomics and personalized medicine.
We will establish a Knowledge Synthesis (KS) Center in Genomics to summarize evidence on genomic applications. This information will be rapidly released to the public. This project will improve patient's safety and outcomes by giving both patients and decision-maker the information they need.