Journal Article

Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations

Seymour, Christopher W, Buxton, Meredith, McVerry, Bryan J, McCreary, Erin K, Berry, Scott, Girard, Timothy D, Montgomery, Stephanie K, Huang, David T, Malakouti, Salim, Clermont, Gilles, King, Andrew J, Garrard, William, Weissman, Alexandra, Angus, Derek C, Adams, Peter W, Linstrum, Kelsey, Horvat, Christopher, Mayr, Florian B, Haidar, Ghady

2021

Overview

Background The Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial is a global adaptive platform trial of hospitalized patients with COVID-19. We describe implementation at the first US site, the UPMC health system, and offer recommendations for implementation at other sites. Methods To implement REMAP-COVID, we focused on six major areas: engaging leadership, trial embedment, remote consent and enrollment, regulatory compliance, modification of traditional trial management procedures, and alignment with other COVID-19 studies. Results We recommend aligning institutional and trial goals and sharing a vision of REMAP-COVID implementation as groundwork for learning health system development. Embedment of trial procedures into routine care processes, existing institutional structures, and the electronic health record promotes efficiency and integration of clinical care and clinical research. Remote consent and enrollment can be facilitated by engaging bedside providers and leveraging institutional videoconferencing tools. Coordination with the central institutional review board will expedite the approval process. Protocol adherence, adverse event monitoring, and data collection and export can be facilitated by building electronic health record processes, though implementation can start using traditional clinical trial tools. Lastly, establishment of a centralized institutional process optimizes coordination of COVID-19 studies. Conclusions Implementation of the REMAP-COVID trial within a large US healthcare system is feasible and facilitated by multidisciplinary collaboration. This investment establishes important groundwork for future learning health system endeavors. Trial registration NCT02735707 . Registered on 13 April 2016.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adaptive Clinical Trials as Topic / Adaptive trial / Anti-Bacterial Agents - therapeutic use / Antiviral Agents - therapeutic use / Biomedicine / Clinical trial / Clinical Trials, Phase IV as Topic / Community-Acquired Infections - therapy / Coronavirus / Coronaviruses / COVID-19 / COVID-19 - therapy / Disease transmission / Drug dosages / Drug stores / Electronic health records / Enrollments / Epidemics / Evidence-Based Medicine / Health Sciences / Humans / Information dissemination / Leadership / Medicine / Medicine & Public Health / Methodology / Multicenter Studies as Topic / Pandemics / Patients / Pharmacy / Platform trial / Pneumonia - therapy / Point-of-Care Systems / Political aspects / Randomized Controlled Trials as Topic / Review boards / SARS-CoV-2 / Severe acute respiratory syndrome coronavirus 2 / Statistics for Life Sciences / Telemedicine / United States