Adapting an Expanded Access program to enable investigational treatments for COVID-19.
Adapting an Expanded Access program to enable investigational treatments for COVID-19.
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DOI：
10.1017/cts.2022.403
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发表时间：
2022
影响因子：
2.6
通讯作者：
Weatherwax, Kevin
中科院分区：
文献类型：
--
作者：
Samuels, Elias;Champagne, Ellen;Gravelin, Misty;Racklyeft, Jamie;Weatherwax, Kevin
对美国国立卫生研究院临床和转化科学奖（CTSA）中心支持的举措进行回顾性案例研究，可用于确定转化科学的促进因素和障碍。本案例研究调查了CTSA扩大准入计划如何适应2020年发布的不断变化的FDA指南，以支持密歇根州临床医生治疗COVID-19患者。我们研究了该计划在大流行期间如何改变，以支持医生对瑞德西韦、恢复期血浆和其他未经批准的药物和新型医疗器械的使用要求。本案例研究采用了由CTSA评估人员制定的卫生干预措施回顾性转化科学案例研究方案。数据收集方法包括7次访谈和对机构数据、同行评议出版物、新闻报道和其他公共记录的回顾。确定的障碍包括不断发展的指导、组织操作的不一致以及研究基础设施的复杂性。翻译的促进因素包括研究和护理团队之间的合作，与广泛的支持者网络的增加接触，以及研究人员的持续专业发展。本案例研究的结果可用于为今后对翻译过程基础原则的调查提供信息。
Retrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians’ treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians’ requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process.
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影响因子：
2.6
作者：
Lotrecchiano GR;DiazGranados D;Sprecher J;McCormack WT;Ranwala D;Wooten K;Lackland D;Billings H;Brasier AR
通讯作者：
Brasier AR
影响因子：
2.6
作者：
Hwang, Soohyun;Birken, Sarah A.;Smith, Justin D.
通讯作者：
Smith, Justin D.
影响因子：
4.3
作者：
Jones, Lindsey;Ludi, Eva;Barihaihi, Margaret
通讯作者：
Barihaihi, Margaret
影响因子：
2.6
作者：
Gravelin M;Wright J;Holbein MEB;Berro M;Brown JS;Mashour GA;Weatherwax KJ
通讯作者：
Weatherwax KJ
影响因子：
2.6
作者：
Wieland ML;Asiedu GB;Lantz K;Abbenyi A;Njeru JW;Osman A;Goodson M;Ahmed Y;Molina LE;Doubeni CA;Sia IG;Rochester Healthy Community Partnership COVID-19 Task Force
通讯作者：
Rochester Healthy Community Partnership COVID-19 Task Force