EQBMED Publishes Research on Site Maturity Assessment to Support Diversity in Clinical Trials
EQBMED Publishes Research on Site Maturity Assessment to Support Diversity in Clinical Trials
NEW HAVEN, Conn., Nov. 20, 2024 /PRNewswire/ -- Equitable Breakthroughs in Medicine (EQBMED) has published one of the program's core innovations, the Site Maturity Assessment Model in Trials. The model is designed to support clinical trial sites to identify opportunities for growth in conducting industry-sponsored clinical trials and enrich diversity of those trials. The approach is holistic, collaborative and site-driven. The model assesses an organization's current and aspirational capabilities, mapping a logical path from initial state to full maturity regarding specific goals. It serves as a diagnostic tool to determine current capacity, prioritize areas for improvement, and track progress toward maturity goals.
康涅狄格州纽黑文,2024年11月20日 /PRNewswire/ —《医学公平突破》(EQBMED)发布了该计划的核心创新之一,即试验中的场地成熟度评估模型。该模型旨在支持临床试验地点,以确定开展行业赞助的临床试验的增长机会,并丰富这些试验的多样性。该方法是整体、协作和以站点为导向的。该模型评估了组织当前和理想的能力,绘制了从初始状态到完全成熟的有关特定目标的逻辑路径。它可用作诊断工具,用于确定当前容量、确定需要改进的领域的优先顺序以及跟踪实现成熟度目标的进展情况。
Developed over two years in collaboration with a diverse group of partners—including representatives from pharmaceutical companies, federal organizations, community leaders, scientists, healthcare sites with varying levels of trial readiness, and academic experts—the model has undergone over 20 iterations, demonstrating its adaptability and impact. The process of synthesizing this collective expertise was led by Drs. Leslie Curry and Marcella Nunez-Smith and Ms. Tesheia Harris. The Site Maturity Model integrates two traditionally siloed components of clinical trials—research operations and community engagement—and reflects the importance of organizational leadership in achieving meaningful diversity in clinical trials. The model includes assessment of a site's capacity to address critical barriers to trial diversity, including social determinants of health, trustworthiness of health care providers and research institutions, and the competing pressures on potential participants, such as limited resources and time constraints.
该模型是与包括制药公司、联邦组织、社区领袖、科学家、具有不同试验准备水平的医疗机构以及学术专家在内的多元化合作伙伴合作开发的,经过了20多次迭代,证明了其适应性和影响力。综合这些集体专业知识的过程由莱斯利·库里博士和马塞拉·努内斯-史密斯博士以及特希亚·哈里斯女士领导。研究中心成熟度模型整合了临床试验中传统上相互孤立的两个组成部分——研究运营和社区参与,并反映了组织领导在实现临床试验有意义的多元化方面的重要性。该模型包括评估研究中心解决试验多样性关键障碍的能力,包括健康的社会决定因素、医疗保健提供者和研究机构的可信度以及潜在参与者面临的竞争压力,例如有限的资源和时间限制。
"Our innovative approach with the EQBMED model supports sites in identifying site-specific challenges and developing tailored, actionable strategies to enhance health equity in clinical research," said Dr. Leslie Curry, Professor of Public Health and Management at Yale School of Public Health with expertise in organizational culture, model creation and mixed methods research.
耶鲁大学公共卫生学院具有组织文化、模型创建和混合方法研究专业知识的公共卫生与管理学教授莱斯利·库里博士说:“我们采用EQBMED模型的创新方法支持研究机构识别特定地点的挑战并制定量身定制、可行的策略,以提高临床研究中的健康公平性。”
"Working in partnership with clinical trial sites using the model's rigorous approach to readiness assessment and co-designed goal setting is filling a critical gap in the field," said Marcella Nunez-Smith, MD, MHS, Associate Dean for Health Equity Research and C.N.H. Long Professor of Internal Medicine, Public Health, and Management at Yale University. "The Site Maturity Model and EQBMED as a whole, underscores the importance of partnerships that break down silos and drive operational excellence in advancing the reach of clinical trials."
耶鲁大学健康公平研究副院长、C.N.H. Long内科、公共卫生和管理学教授Marcella Nunez-Smith说:“使用该模型严格的准备情况评估方法和共同设计的目标设定与临床试验机构合作,填补了该领域的关键空白。”“研究中心成熟度模型和整个EQBMED突显了伙伴关系在推进临床试验范围方面的重要性,这些伙伴关系可以打破孤岛并推动卓越运营。”
"Strategic investment in clinical trial diversity requires structured assessment of site maturity as a starting point for transformative, inclusive action," said Tesheia Harris, MBA, MHS, EQBMED Senior Advisor and former Chief Strategy Officer at Yale Center for Clinical Investigation (YCCI) at Yale School of Medicine. "The EQBMED model is pivotal in guiding sites to identify and prioritize key areas to enhance their capability for diverse clinical trials."
耶鲁医学院耶鲁临床研究中心(YCCI)工商管理硕士、MHS、EQBMED高级顾问兼耶鲁临床研究中心(YCCI)前首席战略官特希亚·哈里斯说:“对临床试验多元化的战略投资需要对研究中心成熟度进行结构化评估,以此作为变革性、包容性行动的起点。”“EQBMED模型在指导研究中心确定关键领域并确定其优先顺序以增强其进行各种临床试验的能力方面至关重要。”
The Site Maturity Assessment Model will continue to be implemented at a range of clinical trial sites such as FQHC's, safety net hospitals and health systems with EQBMED and Yale School of Public Health committed to supporting sites on their journey to ensure communities of color and rural residents have access to innovative clinical trials. This model stands as a new standard to support the creation of an accessible landscape medical research, ultimately achieving more representative trial populations and improving health outcomes across diverse communities.
临床试验场地成熟度评估模型将继续在FQHC、安全网医院和卫生系统等一系列临床试验场所实施,EQBMED和耶鲁公共卫生学院承诺为试点的旅程提供支持,以确保有色人种社区和农村居民有机会获得创新的临床试验。该模型是支持创建无障碍环境医学研究的新标准,最终实现更具代表性的试验人群,改善不同社区的健康结果。
About EQBMED
Equitable Breakthroughs in Medicine Development (EQBMED) is a pioneering partnership committed to transforming the landscape of clinical trials by advancing diversity, transparency, and knowledge. This collaborative partnership is led by Yale School of Medicine, Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center at Morehouse School of Medicine, and Vanderbilt University Medical Center, and supported by grant funding from PhRMA. By empowering community-based sites and addressing historical disparities, the program is dedicated to creating a more inclusive future in medicine development. Learn more at EQBMED.org.
关于 EQBMED
药物开发公平突破(EQBMED)是一个开创性的合作伙伴关系,致力于通过促进多样性、透明度和知识来改变临床试验的格局。该合作伙伴关系由耶鲁医学院、莫尔豪斯医学院、莫尔豪斯医学院少数民族机构研究中心协调中心和范德比尔特大学医学中心领导,并得到phRMA的拨款支持。通过赋予社区网站权力和解决历史差距,该计划致力于在药物开发方面创造更具包容性的未来。要了解更多信息,请访问 EQBMED.org。
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SOURCE Equitable Breakthroughs in Medicine Development (EQBMED)
来源《药物开发公平突破》(EQBMED)