Methods Training for Comparative Effectiveness Research in Cancer

比较有效性研究（CER）旨在通过提供有关 癌症治疗中不同替代方案的利弊。虽然随机对照试验通常 被认为是研究的金标准，由于其受控，具有较高的内部效度。 由于环境的复杂性，它们往往不能推广到“现实世界”的人群。临床试验通常会排除大型 部分人口，特别是那些年龄较大或患有共病的人， 研究结果的外部效度。此外，解释性试验通常只比较两三个 干预措施。随着癌症疗法和技术的数量呈指数级增长， 有必要充分比较几种不同干预措施的益处和危害。而 过去的重点是确定干预措施是否可以在最佳条件下发挥作用， 越来越重要的是，干预措施是否也在“现实世界”环境中发挥作用，以及如何发挥作用， 与其他可用的替代品相比。真实世界证据和CER对于充分评价和 在新的卫生干预措施和技术出现时，及时加以定位。很少有培训计划专门针对 CER方法。本申请的首要目标是实施全面的国家CER 初级癌症研究人员的培训计划，包括广泛的医疗保健服务， 癌症护理培训将包括三种主要的CER方法：1）知识综合，包括 系统综述、荟萃分析和决策分析; 2）观察性研究和次要数据 分析登记和其他数据来源，和3）实用的临床试验，和。在第一次完成A 这些主题的一系列互动在线课程，以获得CER的强大知识基础，参与者将 在三个CER中的一个或多个中完成密集的实践培训小组研讨会 方法论。每个参与者将为CER研究制定一个单独的方案，研究问题为 他们的兴趣。感兴趣的主题可以解决整个癌症连续体的任何护理阶段， 包括预防、筛查、诊断、治疗、支持性护理、临终护理和生存。 课程教师将在12个月内为参与者提供个人方法指导和支持 在参加课程后。参与者将是初级研究人员，在全国范围内招募，并隶属于 学术机构，癌症中心或非营利组织（初级教师，研究科学家或后， 博士或临床研究员，期望有一个研究的职业道路）。报名方法包括 参与人数不足的少数群体。这项教育计划旨在支持国家癌症 研究所的教育使命，武装癌症研究人员与创新的工具，需要进行CER。 在癌症研究中扩大CER将导致强大的现实世界证据，可以告知癌症患者， 护理人员、提供者和政策制定者了解癌症治疗方案的益处和危害。

Comparative effectiveness research (CER) aims to inform healthcare decisions by providing evidence on the benefits and harms of different alternatives in cancer care. While randomized controlled trials are often considered to be the gold standard of research and have high internal validity due to their controlled environment, they are often not generalizable to `real-world' populations. Clinical trials often exclude large segments of the population, particularly those who are older or have comorbid conditions, threatening the external validity of the findings. Furthermore, explanatory trials typically compare only two or three interventions. As the number of cancer therapies and technologies increases exponentially, additional methods are necessary to adequately compare benefits and harms across several different interventions. While the emphasis in the past was on determining whether an intervention could work under the best conditions, increasing importance is given to whether interventions also work in `real-world' settings, and how they compare to other available alternatives. Real-world evidence and CER are vital to adequately evaluate and position new health interventions and technologies as they emerge. Few training programs specifically address CER methodologies. The overarching goal of this application is to implement a comprehensive national CER training program for junior cancer investigators, encompassing the broad spectrum of healthcare delivery in cancer care. Training will encompass three major CER methodologies: 1) Knowledge synthesis including systematic reviews, meta-analysis, and decision analysis; 2) Observational studies and secondary data analysis of registries and other sources of data, and 3) Pragmatic clinical trials, and. After first completing a series of interactive online courses in these topics to acquire a strong knowledge base in CER, participants will complete an intensive, hands-on training small group workshop in one or more of the three CER methodologies. Each participant will develop an individual protocol for a CER study, for a research question of their interest. Topics of interest can address any of the stages of care throughout the cancer continuum, including prevention, screening, diagnosis, treatment, supportive care, end-of-life care, and survivorship. Program faculty will provide individual methods guidance and support to participants during the 12 months after enrolling in the course. Participants will be junior investigators, recruited nationally, and affiliated with academic institutions, cancer centers or non-profit organizations (junior faculty, research scientists or post- doctoral or clinical fellows with an expectation of a research career path). Enrollment methods will include engaging underrepresented minorities. This education program is designed to support the National Cancer Institute's educational mission by arming cancer researchers with innovative tools needed to conduct CER. Expanding CER in cancer research will lead to robust real-world evidence, which can inform cancer patients, caregivers, providers and policy-makers of the benefits and harms of cancer treatment options.