: A combination of scientific controversies and flexible regulatory requirements at the US FDA have led to significant gaps in the evidence base for technologies used in diagnosis and post treatment monitoring of cancer. This issue has become of principal concern to all health care payers, to clinicians providing care, and to patients trying to choose among competing alternatives for care. Because of the large economic impact of modern tests to diagnose and monitor disease, the lack of evidence for the use of these tests is also a significant part of the debate on health care reform. This project proposes to establish a unique resource designed to perform comparative effectiveness research on cancer diagnostics to fill this evidence gap. In so doing, we believe this will make cancer care delivery more efficient, more effective, and more scientifically sound. During the two years of funding, we will establish a multi-disciplinary and cross-institutional network of health delivery systems and researchers in Western Washington State (ADVICE) for evaluating the comparative effectiveness of cancer diagnostics in real-world settings. This partnership of organizations not only provides regional population-based data but also represents a variety of health care delivery systems, including fee-for-service private plans, public agencies, and a large managed care system. Our partners'commitment to implementing the research findings make this truly a translational and transformative effort using real world examples and data from populations that are affected by these variations in diagnostic practices. To demonstrate our ability to conduct these types of community-based retrospective and prospective studies, we will conduct two retrospective comparative effectiveness studies as """"""""proof of principle."""""""" The first study we will undertake is a comparative effectiveness assessment of diagnostic tools used for establishing extent of disease among newly diagnosed Stage I - III breast cancer. Our second proof of principle study will be identified by employing a process for identifying subsequent priority topics around in vitro diagnostic and imaging modalities and their clinical applications from our stakeholders. Over the long-term we plan to use the Puget Sound ADVICE network to conduct retrospective and prospective community based comparative effectiveness research with a focus on rapid turnaround, pragmatic observational and randomized studies. The research priorities will be informed by: systematic reviews;discussions with key stakeholders, including payers and community groups to establish research and policy priorities;and assessment of feasibility to perform studies.
The medical device industry has developed new tests for finding cancer, evaluating the spread of disease in a person, and for monitoring the course of disease after treatment. In general, these tests have not undergone complete evaluation by the time of product approval, and rarely have been subjected to a comparative effectiveness analysis. This project proposes to establish a consortium of researchers and health care providing organizations that will devote their expertise to understanding the strengths and weaknesses of these tests and to produce research that will result in guidelines for the use of these tests and a future program of studies to rigorously evaluate these tests.
