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,美國健康與人類服務部(HHS)下屬戰略準備與響應局(ASPR)的生物醫藥先進研究與發展局(BARDA)與Walgreens宣佈戰略合作,以增強分散式臨床試驗創新,作爲分散式臨床運營與研究(D-COHRe)計劃的一部分。該計劃旨在加強美國分散式臨床研究能力,以支持研發美國食品和藥物管理局(FDA)監管的產品,增強臨床創新,以執行更高效和更相關的臨床研究,在現實世界環境中評估其他可能在公共衛生緊急情況下使用的醫療對策。
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.
該合作將利用Walgreens的臨床試驗生態系統,該系統已被證明在使臨床試驗更易接近、更符合美國人口特徵方面發揮了有效作用,並自2022年推出以來已經接觸了超過500萬潛在臨床試驗參與者。
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致力於在日常醫療旅程以及公共衛生緊急情況下,使分散式臨床研究模型更加高效和可到達美國人口。Walgreens一直能夠達到招募目標,並不斷超越全國招募多樣化臨床試驗參與者的平均水平。Walgreens成功採用一種全面的參與者招募方法,利用其實體店和分散式臨床試驗平台接觸患者和潛在參與者,爲他們提供最爲便利的服務。這使Walgreens成爲理想的合作伙伴,幫助增強分散式臨床研究,驗證、試點和實施新產品、技術和方法,以進行遠程和/或分散使用,包括免疫接種、診斷和治療。
"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."
「能夠繼續與BARDA合作,在Walgreens這樣的社區藥房環境中通過分散式模型增強美國的臨床研究,是一種特權。」 Walgreens首席臨床試驗官Ramita Tandon說。「我們的社區藥房網絡和符合合規和安全的臨床試驗平台使我們能夠引領全面的解決方案,使臨床研究成爲患者醫療旅程的重要組成部分,尤其是在國家健康狀況最爲關鍵、公共衛生緊急情況下。」
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%的試驗未能在規定的時間內達成招募目標,每年往往導致數十億美元的延誤。僅有5%的美國人蔘加臨床試驗,這清楚地表明需要增加臨床研究的接觸性和代表性。Walgreens致力於與BARDA合作,幫助使分散式臨床試驗更加易接近並符合美國人口特徵 。
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還與BARDA合作進行第四階段觀察性COVID-19試驗,通過Walgreens社區藥房網絡增強美國公共衛生應對能力。
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