Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic.
Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic.
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DOI：
10.1093/ofid/ofaa602
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发表时间：
2021-03
影响因子：
4.2
通讯作者：
Boulware DR
中科院分区：
文献类型：
--
作者：
Pullen MF;Pastick KA;Williams DA;Nascene AA;Bangdiwala AS;Okafor EC;Hullsiek KH;Skipper CP;Lofgren SM;Engen N;Abassi M;McDonald EG;Lee TC;Rajasingham R;Boulware DR
随着严重急性呼吸综合征冠状病毒2型大流行的演变，显然迫切需要设计良好和迅速进行的随机临床试验。然而，传统的临床试验设计提出了几个挑战。值得注意的是，疾病流行率最初因时间和地区而异，暴发的地点随着时间的推移而在地理上演变。再加上面对面研究访问的职业危害，在传统的面对面临床试验中，及时招募将被证明是困难的。因此，我们的团队选择使用患者报告的结果衡量标准在全国范围内开展基于互联网的临床试验。总共使用传统和社交媒体招募了2795名参与者，通过在线数据捕获系统进行筛选和登记。后续调查和调查提醒同样是通过这一在线系统进行管理的，在数据丢失的情况下，参与者可以通过人工进行外联。在这份报告中，我们介绍了我们运行基于互联网的临床试验的经验，并为世界大流行期间未来临床试验的设计提供了建议。全球SARS-CoV-2大流行对进行高质量的随机临床试验提出了新的挑战。基于互联网的临床试验是克服其中一些挑战的可能途径。在这里，我们提供一些从进行这样的试验中学到的教训。
As the severe acute respiratory syndrome coronavirus 2 pandemic evolved, it was apparent that well designed and rapidly conducted randomized clinical trials were urgently needed. However, traditional clinical trial design presented several challenges. Notably, disease prevalence initially varied by time and region, and the pockets of outbreaks evolved geographically over time. Coupled with an occupational hazard from in-person study visits, timely recruitment would prove difficult in a traditional in-person clinical trial. Thus, our team opted to launch nationwide internet-based clinical trials using patient-reported outcome measures. In total, 2795 participants were recruited using traditional and social media, with screening and enrollment performed via an online data capture system. Follow-up surveys and survey reminders were similarly managed through this online system with manual participant outreach in the event of missing data. In this report, we present a narrative of our experience running internet-based clinical trials and provide recommendations for the design of future clinical trials during a world pandemic. The global SARS-CoV-2 pandemic presents novel challenges to conducting high quality randomized clinical trials. Internet-based clinical trials are a possible avenue for surmounting some of these challenges. Here, we offer some of the lessons learned from conducting such a trial.
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影响因子：
2.7
作者：
Litchfield, J;Freeman, J;Chubb, B
通讯作者：
Chubb, B
影响因子：
39.2
作者：
Skipper, Caleb P.;Pastick, Katelyn A.;Boulware, David R.
通讯作者：
Boulware, David R.
影响因子：
158.5
作者：
Boulware, David R.;Pullen, Matthew F.;Hullsiek, Kathy H.
通讯作者：
Hullsiek, Kathy H.
影响因子：
17
作者：
Magagnoli, Joseph;Narendran, Siddharth;Ambati, Jayakrishna
通讯作者：
Ambati, Jayakrishna
影响因子：
4.2
作者：
Lofgren SM;Nicol MR;Bangdiwala AS;Pastick KA;Okafor EC;Skipper CP;Pullen MF;Engen NW;Abassi M;Williams DA;Nascene AA;Axelrod ML;Lother SA;MacKenzie LJ;Drobot G;Marten N;Cheng MP;Zarychanski R;Schwartz IS;Silverman M;Chagla Z;Kelly LE;McDonald EG;Lee TC;Hullsiek KH;Boulware DR;Rajasingham R
通讯作者：
Rajasingham R