PO.PS01.04 · 人群科学
构建全国性临床试验网络协调中心:来自CP2CT DECC的早期实施结果
Building a national network coordination center for clinical trials: Early implementation outcomes from the CP2CT DECC
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
背景:尽管美国人群的总体癌症死亡率和发病率有所下降,但癌症负担仍然很高,尤其是在服务不足和研究不足的人群中。癌症结局不佳的一个主要因素是缺乏采用科学严谨方法和实施策略以优化临床试验参与者入组和累积的专门努力。将患者群体连接至临床试验(CP2CT)项目实施创新的多层次干预措施,以增强临床试验知晓度并优化促进患者入组的转诊路径。CP2CT数据、评估与协调中心(DECC)支持其数据和评估活动,并协调一个学习协作组,以减轻所有人群癌症负担的关键障碍。
方法:采用实施科学指导的方法,DECC在三年内部署了协调策略:(1)通过精简治理、集中报告和利益相关方整合进行行政结构化;(2)通过通用数据元素(CDEs)、跨网络REDCap系统和多机构数据传输协议(DTA)实现数据标准化;(3)通过网络逻辑模型、评估计划、标准化构念以及带工具的过程评估计划构建评估基础设施;(4)通过内部网站和扩展的演讲系列提供学习支持;以及(5)通过结构化访问进行站点层面的实施促进。
结果:DECC与CP2CT网络和NCI合作,其成就跨越四个领域:(1)行政:建立基础设施,部署集中报告平台,协调关键会议,并加强社区整合。(2)数据:标准化收集,通过DTA确保全网络数据共享,实现协调一致的多站点报告,并为互操作性和科学价值奠定基础。(3)项目评估:通过全网络逻辑模型将CP2CT活动与可测量结果相关联,指导评估,建立共享评估语言,并启动了可迁移的过程评估框架。(4)学习协作组:开发集中式资源枢纽,扩展演讲系列,并通过CP2CT出版政策推进著作权透明度。
结论:CP2CT DECC已建立了一个可持续、可扩展的基础设施,整合了行政协调、标准化数据收集、稳健的项目评估以及协作式学习环境。这些努力增强了临床试验知晓度,优化了转诊路径,并提供了一个可迁移的模式,用于改善全国研究网络中的参与者入组和科学严谨性,最终解决癌症结局中的差异。
查看英文原文 English abstract
Background: Despite the decline in overall mortality and incidence of cancer in the US population, the burden of cancer is still high, especially in underserved and under-researched populations. A major contributor to poor cancer outcomes is the absence of dedicated efforts utilizing scientifically rigorous approaches and implementation strategies to optimize participant enrollment and accrual in clinical trials. The Connecting Patient Populations to Clinical Trials (CP2CT) program implements innovative multilevel interventions to enhance clinical trial awareness and optimize referral pathways that facilitate patient enrollment. The CP2CT Data, Evaluation, and Coordinating Center (DECC) supports its data and evaluation activities, and coordinates a learning collaborative towards mitigating the key barriers of cancer burden in all populations.
Methods: Using an implementation science-informed approach, the DECC deployed coordinated strategies over three years: (1) administrative structuring through streamlined governance, centralized reporting, and stakeholder integration; (2) data standardization via Common Data Elements (CDEs), a cross-network REDCap system, and a multi-institution Data Transfer Agreement (DTA); (3) evaluation infrastructure through a Network Logic Model, evaluation plan, standardized constructs, and a Process Evaluation Plan with tools; (4) learning supports through an internal website and expanded Speaker Series; and (5) site-level implementation facilitation through structured visits.
Results: In collaboration with the CP2CT Network and NCI, the DECC's achievements span four domains: (1) Administrative: built infrastructure, deployed centralized reporting platforms, coordinated key meetings, and strengthened community integration. (2) Data: standardized collection, secured network-wide data sharing through the DTA, enabled harmonized multi-site reporting, and advanced groundwork for interoperability and scientific value. (3) Program Evaluation: linked CP2CT activities to measurable outcomes through a Network-wide Logic Model, guided evaluation, established shared evaluation language, and launched a transferable Process Evaluation framework. (4) Learning Collaborative: developed a centralized resource hub, expanded the Speaker Series, and advanced authorship transparency with the CP2CT Publication Policy. <
Conclusion: The CP2CT DECC has established a sustainable, scalable infrastructure that integrates administrative coordination, standardized data collection, robust program evaluation, and a collaborative learning environment. These efforts enhance clinical trial awareness, optimize referral pathways, and provide a transferable model for improving participant enrollment and scientific rigor across national research networks, ultimately addressing disparities in cancer outcomes.
利益披露 Disclosure
L. E. Lectora, None..
C. J. Orozco, None..
H. A. Thorson, None..
T. Bonner, None..
R. R. Freimuth, None..
J. G. Le-Rademacher, None..
F. T. Odedina, None.