ADVancing Innovative Comparative Effectiveness research-cancer diagnostics ADVICE

描述（由申请人提供）：美国FDA的科学争议和灵活的监管要求的结合导致了用于癌症诊断和治疗后监测的技术的证据基础存在重大差距。这一问题已成为所有卫生保健支付者、提供护理的临床医生以及试图在相互竞争的护理选择中做出选择的患者的主要关切。由于诊断和监测疾病的现代检测对经济的巨大影响，缺乏使用这些检测的证据也是关于卫生保健改革辩论的一个重要部分。该项目建议建立一个独特的资源，旨在对癌症诊断进行比较有效性研究，以填补这一证据空白。这样做，我们相信这将使癌症治疗更有效率，更有效，更科学合理。

DESCRIPTION (Provided by the applicant): 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. PUBLIC HEALTH RELEVANCE: 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.