Bringing research directly to families in the era of COVID-19.
Bringing research directly to families in the era of COVID-19.
复制标题
在COVID-19时代，将研究直接带到家庭。
DOI：
10.1038/s41390-020-01260-1
复制
发表时间：
2021-03
影响因子：
3.6
通讯作者：
Hornik CP
中科院分区：
文献类型：
--
作者：
Balevic SJ;Singler L;Randell R;Chung RJ;Lemmon ME;Hornik CP
2019冠状病毒病（COVID-19）大流行严重扰乱了临床研究。1除了将研究资源转向大流行应对，导致1700多项临床试验停止外，2大多数正在进行的研究都进行了重大修改，以减轻参与者、研究人员和调查人员的感染风险。此外，远程医疗模式代替面对面服务的快速部署扰乱了典型的招聘方法。这场大流行清楚地表明，“以实体为基础的研究非常容易受到危机的影响，这些危机限制了人们使用临床和研究设施。”通过暴露这些脆弱性，大流行也为创新试验设计创造了机会。其中一个例子是分散的、直接面向家庭的研究设计，在这种设计中，招募、干预和数据收集都是远程进行的（例如，在参与者家中）。3-5远程数据收集方法可以消除现场访问的需要，从而使试验更有效率和更具成本效益。6,7与传统试验相比，直接面向家庭的方法可以招募更大、更多样化的参与者。6,8大流行期间的另一个优势是，通过减少或消除参与者与研究人员面对面接触的次数，以及避免与诊所或医院的其他患者接触，能够降低感染风险。美国食品和药物管理局（FDA）在大流行期间开展临床试验的指南中，建议在可能的情况下进行虚拟评估和当地生物样本收集，强调了直接面向家庭方法的好处。此外，包括西方机构审查委员会在内的监管机构的领导人提倡使用远程数据收集。10 .这一流行病加剧了儿科门诊保健领域的现有趋势，家庭消费主义的增加给当前护理模式的未来带来了不确定性。直接面向家庭的研究是一个前所未有的机会，可以在2019冠状病毒病大流行期间应对儿科护理的这些变化，并增加临床试验的可及性。在此，我们分享了促进直接面向家庭的研究的规划、设计和实施的关键原则。
The Coronavirus disease 2019 (COVID-19) pandemic is profoundly disrupting clinical research. 1 In addition to the diversion of research resources towards the pandemic response, resulting in the halting of over 1700 clinical trials, 2 most ongoing studies have undergone substantial modifications to mitigate infection risk for participants, research staff, and investigators. 1 Furthermore, the rapid deployment of telemedicine modalities in lieu of face-toface services disrupts typical recruitment methods. The pandemic clearly demonstrates that “brick-and-mortar7 site-based research is exquisitely vulnerable to crises that limit access to clinical and research facilities.By exposing these vulnerabilities, the pandemic also creates opportunities for innovative trial designs. One such example is the decentralized, direct-to-family study design, in which recruitment, intervention, and data collection all occur remotely (eg, in participantsL homes). 3-5 Remote data collection methods can eliminate the need for site visits, resulting in trials that are more efficient and cost effective. 6, 7 Direct-to-family approaches can recruit larger and more diverse participants compared to traditional trials. 6, 8 An additional advantage during pandemics is the ability to mitigate infectious risk by reducing or eliminating the number of face-to-face encounters between participants and study staff, and avoiding exposure to other patients in the clinic or hospital. Underscoring the benefits of direct-to-family approaches, the US Food and Drug Administration (FDA) recommended virtual assessment and local biosample collection when possible in its guidance for conducting clinical trials during the pandemic. 9 Further, leaders from regulatory bodies including the Western Institutional Review Board have advocated the use of remote data collection. 10 The pandemic accentuates existing trends in the pediatric ambulatory healthcare landscape, with increasing consumerism among families creating uncertainty about the future of current care models. 11 Direct-to-family research is an unprecedented opportunity to respond to these evolutions in pediatric care and increase access to clinical trials during the COVID-19 pandemic and beyond. Herein we share key principles to facilitate the planning, design, and implementation of direct-to-family research studies.
登录
查看更多内容
影响因子：
3.8
作者：
Hansen, Thomas V. O.;Simonsen, Mette K.;Hundrup, Yrsa Andersen
通讯作者：
Hundrup, Yrsa Andersen
影响因子：
1.5
作者：
Levitan, Bennett;Getz, Kenneth;DiMasi, Joseph
通讯作者：
DiMasi, Joseph
影响因子：
2.7
作者：
Carlisle, Benjamin Gregory;Doussau, Adelaide;Kimmelman, Jonathan
通讯作者：
Kimmelman, Jonathan
影响因子：
2.2
作者：
Orri, Miguel;Lipset, Craig H.;Cummings, Steven R.
通讯作者：
Cummings, Steven R.
影响因子：
2.2
作者：
Rosa, Carmen;Campbell, Aimee N. C.;Winstanley, Erin L.
通讯作者：
Winstanley, Erin L.