Center for Comparative Effectiveness Research in Cancer Genomics - CANCERGEN

癌症基因组学比较有效性研究中心 - CANCERGEN

• 批准号: 7861060
• 负责人: SCOTT D. RAMSEY
• 金额: $ 204.11万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-29 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7861060
• 关键词: Address; Adjuvant Chemotherapy; Clinical; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Design; Clinical Trials Network; Complement; Consensus; Consensus Development; Cooperative Group Program; Data Set; Databases; Decision Modeling; Development; Disease; Effectiveness; Ethics; Evaluation; Fred Hutchinson Cancer Research Center; Funding Mechanisms; Gene Expression Profiling; Genomics; Health; Health Insurance; Health system; Insurance Carriers; Interdisciplinary Study; Journals; Malignant Neoplasms; Manuscripts; Marketing; Medical Technology; Medicine; Methods; Modeling; National Cancer Institute; Outcome; Paper; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Policies; Positive Lymph Node; Practice Guidelines; Prevention; Process; Protocols documentation; Public Health; Publishing; Randomized Clinical Trials; Randomized Controlled Trials; Research Design; Research Infrastructure; Research Personnel; Research Priority; Societies; Southwest Oncology Group; Staging; Structure; Techniques; Technology; Testing; Time; Translations; United States; Universities; Vision; Washington; Woman; cancer care; cancer genomics; cancer therapy; clinical care; clinical practice; comparative effectiveness; cost; cost effectiveness; cost utility analysis; design; disorder risk; economic evaluation; economic value; effectiveness research; genetic profiling; improved; innovation; malignant breast neoplasm; medical specialties; meetings; multidisciplinary; novel; outcome forecast; practical application; pragmatic trial; prospective; public health relevance; research study; response; standard care

DESCRIPTION (Provided by the applicant): A number of genomic applications for cancer have become available for assessing disease risk, prognosis, and drug response prediction, offering the promise of effective and efficient cancer care tailored to the genetic profile of the patient or disease - Genomics and Personalized Medicine (GPM). The current regulatory structure - which focuses on analytical accuracy rather than clinical validity or utility - creates a potential that genomic tests will be introduced into clinical practice without sufficient evidence supporting their value compared to standard care, or conversely that tests that provide high clinical utility and value will not be utilized or reimbursed in practice. In many cases, evidence from randomized controlled trials (RCTs) will be needed to establish clinical value. To provide useful information for decision makers, such trials will need to extend beyond traditional designs to include patient outcomes and economic evaluation. In addition, greater use of trial designs that more closely represent clinical practice, such as pragmatic trials, are needed. The National Cancer Institute (NCI)-supported cancer clinical trials Cooperative Group Program offers a compelling infrastructure for the conduct of high-quality prospective comparative effectiveness research (CER) studies of GPM applications for cancer. To maximize the impact of this infrastructure on cancer practice, it is also critical to develop methods for identifying CER topics in cancer genomics that are priorities from multiple stakeholder perspectives. In addition, to address the challenge of making innovative GPM technologies available to patients while at the same time generating high quality evidence needed by decision makers, novel shared funding mechanisms such as Coverage with Evidence Development (CED) are needed. We propose to develop a Center for Comparative Effectiveness Research in Cancer Genomics (CANCERGEN), a sustainable, multidisciplinary, collaborative consortium including the Fred Hutchinson Cancer Research Center, the Center for Medical Technology Policy, University of Washington, and the Southwest Oncology Group, one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative groups in the United States. CANCERGEN will integrate expertise in decision modeling, database linkage, ethics, policy, and clinical trial design in order to leverage and build upon the existing strengths of the SWOG clinical trials network to facilitate the rapid design and implementation of prospective CER studies of GPM technologies. Moreover, CANCERGEN will create a unique and valuable partnership with the Center for Medical Technology Policy, whereby multidisciplinary stakeholders will collaborate with CANCERGEN to identify research priorities. Our vision is that CANCERGEN will overcome structural barriers that have limited the quality and timeliness of evaluations in GPM, with the result that promising technologies in the cancer genomics pipeline can move rapidly from "proof of principle" to improving the effectiveness and costeffectiveness of cancer clinical care. PUBLIC HEALTH RELEVANCE: A variety of genomic and personalized medicine applications for cancer offer the promise of improved cancer care, but the process by which genomic tests move from development to market availability rarely generates high quality evidence supporting their clinical utility or economic value. To address this problem, we will create a Center that includes researchers from the Fred Hutchinson Cancer Research Center, the Center for Medical Technology Policy, the University of Washington, and the Southwest Oncology Group, one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative groups in the United States. This collaborative network will overcome barriers that have limited the quality and timeliness of evaluations in genomics and personalized medicine, with the result that promising technologies currently in the cancer genomics pipeline can move rapidly from "proof of principle" to improving the effectiveness and cost effectiveness of cancer clinical care to benefit public health.

描述（由申请人提供）：许多癌症基因组学应用已可用于评估疾病风险、预后和药物反应预测，提供了针对患者或疾病遗传特征定制的有效和高效癌症护理的承诺-基因组学和个性化医学（GPM）。目前的监管结构-侧重于分析准确性，而不是临床有效性或实用性-创造了一种可能性，即基因组测试将被引入临床实践，而没有足够的证据支持其与标准护理相比的价值，或者相反，提供高临床实用性和价值的测试将不会在实践中使用或报销。在许多情况下，需要随机对照试验（RCT）的证据来确定临床价值。为了给决策者提供有用的信息，这些试验需要超越传统的设计，包括病人的结果和经济评估。此外，需要更多地使用更能代表临床实践的试验设计，如实用性试验。美国国家癌症研究所（NCI）支持的癌症临床试验合作小组计划为开展GPM应用于癌症的高质量前瞻性比较有效性研究（CER）提供了一个引人注目的基础设施。为了最大限度地发挥这一基础设施对癌症实践的影响，还必须制定方法，从多个利益相关者的角度确定癌症基因组学中的CER主题。此外，为了应对向患者提供创新GPM技术的挑战，同时生成决策者所需的高质量证据，需要新的共享资金机制，如证据开发覆盖（CED）。 我们建议建立一个癌症基因组学比较有效性研究中心（CANCERGEN），这是一个可持续的、多学科的合作联盟，包括弗雷德哈钦森癌症研究中心、华盛顿大学医疗技术政策中心和西南肿瘤组，西南肿瘤组是美国国家癌症研究所支持的最大的癌症临床试验合作组之一。CANCERGEN将整合决策建模、数据库链接、伦理、政策和临床试验设计方面的专业知识，以利用和建立SWOG临床试验网络的现有优势，促进GPM技术前瞻性CER研究的快速设计和实施。此外，CANCERGEN将与医疗技术政策中心建立独特而有价值的伙伴关系，多学科利益相关者将与CANCERGEN合作，以确定研究重点。我们的愿景是，CANCERGEN将克服结构性障碍，这些障碍限制了GPM评估的质量和及时性，结果是癌症基因组学管道中有前途的技术可以迅速从“原理证明”转变为提高癌症临床护理的有效性和成本效益。 公共卫生相关性：各种基因组和个性化的癌症医学应用提供了改善癌症护理的承诺，但基因组测试从开发到市场可用性的过程很少产生高质量的证据支持其临床实用性或经济价值。为了解决这一问题，我们将建立一个中心，其中包括来自弗雷德哈钦森癌症研究中心、医学技术政策中心、华盛顿大学和西南肿瘤学小组的研究人员，西南肿瘤学小组是美国国家癌症研究所支持的最大的癌症临床试验合作小组之一。这一合作网络将克服限制基因组学和个性化医疗评价质量和及时性的障碍，其结果是，目前在癌症基因组学管道中的有前途的技术可以迅速从“原理证明”转向提高癌症临床护理的有效性和成本效益，以造福公众健康。