Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic.
Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic.
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DOI：
10.1017/cts.2021.15
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发表时间：
2021-02-26
影响因子：
2.6
通讯作者：
Weatherwax KJ
中科院分区：
文献类型：
--
作者：
Gravelin M;Wright J;Holbein MEB;Berro M;Brown JS;Mashour GA;Weatherwax KJ
由于最初没有获得批准的COVID-19治疗方法，美国食品和药物管理局利用多种预先批准途径来提供研究药物和/或医疗器械：扩大使用，紧急使用授权和临床试验。学术医学中心（AMC）内的监管部门，包括临床和转化科学奖（CTSA）联盟的成员，在大流行之前为临床医生提供了这些选择的支持。因此，他们被定位为在COVID-19公共卫生紧急情况期间获得治疗的资源。于二零二零年十月及十二月，国家新药试验（IND）/试验用器械豁免（IDE）工作组进行了一项小型调查及后续调查，以确定CTSA监管单位是否协助促进获得COVID-19治疗以及这些单位面临的大流行相关挑战的程度。我们收到15份调查及21份民意调查回应，深入了解疫情对这些监管支援单位的需求，以及在当前及未来危机期间提供关键支援所需的变化。关键的变化和经验教训包括监管知识对支持机构应对的重要性，对食品药品监督管理局（FDA）文件电子提交能力的迫切需求，以及在大流行期间灵活重新分配监管和法律的资源以支持患者获得研究药物和/或医疗器械。AMC和CTSA的监管部门在COVID-19疫情中发挥了重要作用，但需要进一步调整部门，以便在未来提供更有力的监管支持。
With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regulatory units within an Academic Medical Center (AMC), including those part of the Clinical and Translational Science Award (CTSA) consortium, have provided support for clinicians in navigating these options prior to the pandemic. As such, they were positioned to be a resource for accessing therapies during the COVID-19 public health emergency. A small survey and a follow-on poll of the national Investigational New Drug (IND)/Investigational Device Exemption (IDE) Workgroup were conducted in October and December 2020 to determine whether CTSA regulatory units assisted in facilitating access to COVID-19 therapies and the extent of pandemic-related challenges these units faced. Fifteen survey and 21 poll responses were received, which provided insights into the demands placed on these regulatory support units due to the pandemic and the changes required to provide critical support during this and future crises. Key changes and lessons learned included the importance of regulatory knowledge to support the institutional response, the critical need for electronic submission capacity for Food and Drug Administration (FDA) documents, and the nimble reallocation of regulatory and legal resources to support patient access to investigational agents and/or medical devices during the pandemic. AMC- and CTSA-based regulatory units played a meaningful role in the COVID-19 pandemic but further unit modifications are needed for enabling more robust regulatory support in the future.
影响因子：
11.8
作者：
Harcourt, Jennifer;Tamin, Azaibi;Thornburg, Natalie J.
通讯作者：
Thornburg, Natalie J.
影响因子：
7.4
作者：
Berro, Marlene;Burnett, Bruce K.;Speicher, Lisa A.
通讯作者：
Speicher, Lisa A.