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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

EQBMED發佈了關於現場成熟度評估的研究,以支持臨床試驗中的多樣性
PR Newswire ·  2024/11/20 22:00

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/美通社/ - 醫學領域的公平突破(EQBMED)已經發布了該項目的核心創新之一《試驗現場成熟度評估模型》。該模型旨在支持臨床試驗現場識別在進行由行業贊助的臨床試驗時增長機會,並豐富這些試驗的多樣性。這種方法是全面的、協作的和以現場爲驅動力的。該模型評估組織當前和願望能力,繪製從初始狀態到實現特定目標的完全成熟的合乎邏輯的路徑。它作爲一種診斷工具,用於確定當前容量,優先考慮改進建議,並跟蹤朝着成熟目標的進展。

EQBMED Publishes Research on Site Maturity Assessment to Support Diversity in Clinical Trials
EQBMED發佈了支持臨床試驗多樣性的現場成熟度評估研究

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.

在與包括來自藥品公司、聯邦機構、社區領袖、科學家、具有不同試驗準備水平的醫療服務機構以及學術專家在內的各種合作伙伴的兩年合作中開發的該模型經歷了20多次迭代,展示了它的適應性和影響力。合成這種集體專業知識的過程由Leslie Curry博士、Marcella Nunez-Smith博士和Tesheia Harris女士領導。《試驗現場成熟度模型》整合了臨床試驗中傳統上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中有意義的多樣性方面的重要性。該模型包括評估一個現場應對試驗多樣性關鍵障礙的能力,包括健康社會決定因素、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.

「我們與EQBMED模型的創新方法支持試驗現場識別特定挑戰,並制定量身定製的可行策略,以增強臨床研究中的健康公平,」耶魯大學公共衛生與管理學教授Leslie Curry博士表示。她在組織文化、模型創建和混合研究方法方面擁有專業知識。

"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."

與臨床試驗點合作,採用該模型嚴謹的準備評估和共同設計的目標設定,填補了該領域的重要空白,馬塞拉·努內斯-史密斯(Marcella Nunez-Smith)醫學博士、MHS,耶魯大學健康公平研究副院長和C.N.H.朗教授(內科、公共衛生和管理)。"站點成熟度模型和EQBMED作爲一個整體,強調打破信息孤島、推動運營卓越,促進臨床試驗的覆蓋範圍擴大的合作伙伴關係的重要性。

"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."

"對臨床試驗多樣性進行戰略投資需要對站點成熟度進行結構化評估,作爲轉型、包容行動的起點,"特西亞·賀錦麗(Tesheia Harris)MBA、MHS,EQBMED高級顧問,前耶魯醫學院臨床調查中心(YCCI)首席策略官。"EQBMED模型在引導站點識別和優先考慮增強其進行多元化臨床試驗的能力的關鍵領域方面發揮了關鍵作用。"

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.

站點成熟度評估模型將繼續在一系列的臨床試驗點(如FQHC、安全網醫院和健康系統)中實施,EQBMED和耶魯公共衛生學院致力於支持站點在他們的旅程中,以確保有色人種社區和農村居民能夠獲得創新的臨床試驗。該模型作爲支持創建可訪問的醫療研究領域的新標準,最終實現更具代表性的試驗人群,並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
平等醫學突破(EQBMED)是一個致力於通過促進多樣性、透明度和知識來改變臨床試驗格局的開創性合作伙伴關係。這個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族裔研究中心協調中心和範德堡大學醫學中心領導,並得到了製藥研究和製藥製造協會的資助。通過賦予社區基地和解決歷史差異,該計劃致力於打造醫學發展的更加包容性的未來。了解更多信息,請訪問EQBMED.org。

Media Contact: [email protected]

媒體聯繫人:[email protected]

SOURCE Equitable Breakthroughs in Medicine Development (EQBMED)

資訊公平突破醫學發展(EQBMED)

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