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Lessons Learned From Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic.
Pullen, Matthew F; Pastick, Katelyn A; Williams, Darlisha A; Nascene, Alanna A; Bangdiwala, Ananta S; Okafor, Elizabeth C; Hullsiek, Katherine Huppler; Skipper, Caleb P; Lofgren, Sarah M; Engen, Nicole; Abassi, Mahsa; McDonald, Emily G; Lee, Todd C; Rajasingham, Radha; Boulware, David R.
  • Pullen MF; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Pastick KA; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Williams DA; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Nascene AA; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Bangdiwala AS; School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Okafor EC; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Hullsiek KH; School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Skipper CP; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Lofgren SM; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Engen N; School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.
  • Abassi M; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • McDonald EG; Department of Medicine, McGill University, Montreal, Québec, Canada.
  • Lee TC; Department of Medicine, McGill University, Montreal, Québec, Canada.
  • Rajasingham R; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
  • Boulware DR; Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Open Forum Infect Dis ; 8(2): ofaa602, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1069290
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid