Methods Training for Comparative Effectiveness Research in Cancer

癌症比较有效性研究方法培训

基本信息

批准号：
10768862
负责人：
Maria E Suarez-Almazor
金额：
$ 32.11万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-21 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10768862
关键词：
Address Advisory Committees Alternative Health Area Cancer Center Cancer Patient Career Choice Caregivers Caring Clinical Clinical Trials Comparative Effectiveness Research Controlled Environment Country Data Data Analyses Data Set Decision Analysis Decision Making Decision Modeling Development Diagnosis Discipline of Nursing Education Educational Activities Educational Curriculum Educational workshop Effectiveness of Interventions Enrollment Ensure Exclusion Faculty Fellowship Program Foundations Goals Health Health Sciences Healthcare Individual Institution Intervention Knowledge Length Link Malignant Neoplasms Medical Medicare claim Meta-Analysis Methodology Methods Mission Modeling National Cancer Institute Nonprofit Organizations Observational Study Oncology Outcome Participant Patient-Focused Outcomes Patients Pattern Persons Play Policy Maker Population Positioning Attribute Postdoctoral Fellow Pragmatic clinical trial Prevention Probability Process Program Evaluation Protocols documentation Provider Public Health Quality of life Randomized, Controlled Trials Registries Research Research Methodology Research Personnel Research Training Role SEER Program Scientist Series Source Supportive care Technology Training Training Activity Training Programs Underrepresented Minority Work anticancer research arm cancer care cancer therapy care providers comorbidity comparative comparative effectiveness design effectiveness evaluation effectiveness study end of life care evidence based guidelines expectation health care delivery innovation interest knowledge base knowledge translation lectures new technology novel strategies online course patient oriented pragmatic trial programs protocol development recruit research study screening skills survivorship systematic review tool trial comparing

项目摘要

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.

比较有效性研究 (CER) 旨在通过提供有关以下方面的证据来为医疗保健决策提供信息：癌症治疗中不同替代方案的好处和坏处。虽然随机对照试验经常被认为是研究的黄金标准，并且由于其受控性而具有较高的内部效度环境，它们往往不能推广到“现实世界”的人群。临床试验通常排除大部分人口，特别是老年人或患有合并症的人，威胁着研究结果的外部有效性。此外，解释性试验通常只比较两个或三个干预措施。随着癌症疗法和技术的数量呈指数级增长，额外的方法有必要充分比较几种不同干预措施的益处和危害。虽然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，人们越来越重视干预措施是否也能在“现实世界”环境中发挥作用，以及它们如何发挥作用。与其他可用的替代方案进行比较。真实世界的证据和 CER 对于充分评估和及时定位新的健康干预措施和技术。很少有培训计划专门针对 CER 方法。该应用程序的总体目标是实施全面的国家 CER 初级癌症研究人员培训计划，涵盖广泛的医疗保健服务癌症护理。培训将涵盖三种主要的 CER 方法： 1) 知识综合，包括系统评价、荟萃分析和决策分析； 2) 观察性研究和二手数据注册和其他数据来源的分析，以及 3) 实用的临床试验，以及。第一次完成后这些主题的一系列互动在线课程，以获得强大的 CER 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 研究制定单独的方案，针对以下研究问题：他们的兴趣。感兴趣的主题可以涉及整个癌症连续过程中的任何护理阶段，包括预防、筛查、诊断、治疗、支持性护理、临终关怀和生存。项目教师将在 12 个月内为参与者提供个人方法指导和支持注册课程后。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、研究科学家或后期望从事研究职业道路的博士或临床研究员）。报名方式将包括吸引代表性不足的少数群体。该教育计划旨在支持国家癌症中心研究所的教育使命是为癌症研究人员提供进行 CER 所需的创新工具。扩大癌症研究中的 CER 将带来强有力的现实世界证据，可以为癌症患者提供信息，护理人员、提供者和政策制定者了解癌症治疗方案的好处和危害。