Walgreens and BARDA Form Strategic Partnership to Strengthen Decentralized Clinical Trials Model and Reporting
Walgreens and BARDA Form Strategic Partnership to Strengthen Decentralized Clinical Trials Model and Reporting
DEERFIELD, Ill. AUG. 19, 2024-- Walgreens and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), today announced a strategic partnership to increase innovation in decentralized clinical trials as part of the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. The program is designed to strengthen U.S. decentralized clinical research capabilities to support development of U.S. Food and Drug Administration (FDA)-regulated products, enhance clinical innovation to execute more efficient and relevant clinical research and evaluate other medical countermeasures in real world environments that may be used in a public health emergency.
2024年8月19日,美国健康与人类服务部(HHS)下属战略准备与响应局(ASPR)的生物医药先进研究与发展局(BARDA)与Walgreens宣布战略合作,以增强分散式临床试验创新,作为分散式临床运营与研究(D-COHRe)计划的一部分。该计划旨在加强美国分散式临床研究能力,以支持研发美国食品和药物管理局(FDA)监管的产品,增强临床创新,以执行更高效和更相关的临床研究,在现实世界环境中评估其他可能在公共卫生紧急情况下使用的医疗对策。
The partnership will utilize Walgreens's clinical trial ecosystem, which has proven effective in making clinical trials more accessible and representative of the U.S. population and has reached more than five million patients to potentially recruit into clinical trials since its launch in 2022.
该合作将利用Walgreens的临床试验生态系统,该系统已被证明在使临床试验更易接近、更符合美国人口特征方面发挥了有效作用,并自2022年推出以来已经接触了超过500万潜在临床试验参与者。
Walgreens is committed to making decentralized clinical research models more efficient and accessible to the U.S. population during their routine healthcare journey and during public health emergencies. Walgreens has consistently met recruitment goals and has continuously surpassed national averages for recruiting diverse clinical trial participants for its sponsor-led clinical trials. Walgreens successfully activates a comprehensive approach to participant recruitment that utilizes its physical footprint and its decentralized clinical trial platform to engage patients and potential patients where it's most convenient for them. This positions Walgreens as the ideal partner to help enhance decentralized clinical research to validate, pilot and implement new products, technologies and approach for remote and/or decentralized use during a public health emergency, including immunizations, diagnostics, and treatments.
Walgreens致力于在日常医疗旅程以及公共卫生紧急情况下,使分散式临床研究模型更加高效和可到达美国人口。Walgreens一直能够达到招募目标,并不断超越全国招募多样化临床试验参与者的平均水平。Walgreens成功采用一种全面的参与者招募方法,利用其实体店和分散式临床试验平台接触患者和潜在参与者,为他们提供最为便利的服务。这使Walgreens成为理想的合作伙伴,帮助增强分散式临床研究,验证、试点和实施新产品、技术和方法,以进行远程和/或分散使用,包括免疫接种、诊断和治疗。
"It is a privilege to continue our partnership with BARDA to strengthen clinical research in the U.S. through a decentralized model in a community pharmacy setting like Walgreens," said Ramita Tandon, chief clinical trials officer at Walgreens. "Our network of community pharmacies and our compliant and secure clinical trial platform enables us to pioneer a comprehensive solution to make clinical research an integral part of a patient's healthcare journey, especially when it is most critical for the well-being of our country, during a public health emergency."
“能够继续与BARDA合作,在Walgreens这样的社区药房环境中通过分散式模型增强美国的临床研究,是一种特权。” Walgreens首席临床试验官Ramita Tandon说。“我们的社区药房网络和符合合规和安全的临床试验平台使我们能够引领全面的解决方案,使临床研究成为患者医疗旅程的重要组成部分,尤其是在国家健康状况最为关键、公共卫生紧急情况下。”
Nearly 80% of trials fail to meet their enrollment goals in the stated timeframes, often contributing to billions of dollars in delays annually. With only 5% of the U.S. population participating in clinical trials, there is a clear need to increase access and representation in clinical research. Walgreens is committed to working with BARDA to help make decentralized clinical trials more accessible and representative of the U.S. population.
近80%的试验未能在规定的时间内达成招募目标,每年往往导致数十亿美元的延误。仅有5%的美国人参加临床试验,这清楚地表明需要增加临床研究的接触性和代表性。Walgreens致力于与BARDA合作,帮助使分散式临床试验更加易接近并符合美国人口特征 。
Walgreens is also partnering with BARDA on a Phase IV observational COVID-19 trial to enhance U.S. public health preparedness through the Walgreens community pharmacy network.
Walgreens还与BARDA合作进行第四阶段观察性COVID-19试验,通过Walgreens社区药房网络增强美国公共卫生应对能力。
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