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.
康涅狄格州紐黑文,2024年11月20日 /PRNewswire/ —《醫學公平突破》(EQBMED)發佈了該計劃的核心創新之一,即試驗中的場地成熟度評估模型。該模型旨在支持臨床試驗地點,以確定開展行業贊助的臨床試驗的增長機會,並豐富這些試驗的多樣性。該方法是整體、協作和以站點爲導向的。該模型評估了組織當前和理想的能力,繪製了從初始狀態到完全成熟的有關特定目標的邏輯路徑。它可用作診斷工具,用於確定當前容量、確定需要改進的領域的優先順序以及跟蹤實現成熟度目標的進展情況。
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.
該模型是與包括製藥公司、聯邦組織、社區領袖、科學家、具有不同試驗準備水平的醫療機構以及學術專家在內的多元化合作夥伴合作開發的,經過了20多次迭代,證明了其適應性和影響力。綜合這些集體專業知識的過程由萊斯利·庫裏博士和馬塞拉·努內斯-史密斯博士以及特希亞·賀錦麗女士領導。研究中心成熟度模型整合了臨床試驗中傳統上相互孤立的兩個組成部分——研究運營和社區參與,並反映了組織領導在實現臨床試驗有意義的多元化方面的重要性。該模型包括評估研究中心解決試驗多樣性關鍵障礙的能力,包括健康的社會決定因素、醫療保健提供者和研究機構的可信度以及潛在參與者面臨的競爭壓力,例如有限的資源和時間限制。
"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.
耶魯大學公共衛生學院具有組織文化、模型創建和混合方法研究專業知識的公共衛生與管理學教授萊斯利·庫裏博士說:「我們採用EQBMED模型的創新方法支持研究機構識別特定地點的挑戰並制定量身定製、可行的策略,以提高臨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."
耶魯大學健康公平研究副院長、C.N.H. Long內科、公共衛生和管理學教授Marcella Nunez-Smith說:「使用該模型嚴格的準備情況評估方法和共同設計的目標設定與臨床試驗機構合作,填補了該領域的關鍵空白。」「研究中心成熟度模型和整個EQBMED突顯了夥伴關係在推進臨床試驗範圍方面的重要性,這些夥伴關係可以打破孤島並推動卓越運營。」
"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."
耶魯醫學院耶魯臨床研究中心(YCCI)工商管理碩士、MHS、EQBMED高級顧問兼耶魯臨床研究中心(YCCI)前首席戰略官特希亞·賀錦麗說:「對臨床試驗多元化的戰略投資需要對研究中心成熟度進行結構化評估,以此作爲變革性、包容性行動的起點。」「EQBMED模型在指導研究中心確定關鍵領域並確定其優先順序以增強其進行各種臨床試驗的能力方面至關重要。」
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.
臨床試驗場地成熟度評估模型將繼續在FQHC、安全網醫院和衛生系統等一系列臨床試驗場所實施,EQBMED和耶魯公共衛生學院承諾爲試點的旅程提供支持,以確保有色人種社區和農村居民有機會獲得創新的臨床試驗。該模型是支持創建無障礙環境醫學研究的新標準,最終實現更具代表性的試驗人群,改善不同社區的健康結果。
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.
關於 EQBMED
藥物開發公平突破(EQBMED)是一個開創性的合作伙伴關係,致力於通過促進多樣性、透明度和知識來改變臨床試驗的格局。該合作伙伴關係由耶魯醫學院、莫爾豪斯醫學院、莫爾豪斯醫學院少數民族機構研究中心協調中心和範德比爾特大學醫學中心領導,並得到phRMA的撥款支持。通過賦予社區網站權力和解決歷史差距,該計劃致力於在藥物開發方面創造更具包容性的未來。要了解更多信息,請訪問 EQBMED.org。
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SOURCE Equitable Breakthroughs in Medicine Development (EQBMED)
來源《藥物開發公平突破》(EQBMED)