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Domains test investigational treatments with similar mechanisms of action, and multiple domains are simultaneously tested such that patients are randomized within each domain for which they are eligible.
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Multiple investigational treatments are layered within the core protocol as “domains”.
#Universal control remapper no device groups trial#
Briefly, REMAP-CAP is governed by an International Trial Steering Committee (ITSC) and uses a core protocol that defines broad eligibility criteria, outcomes, and the statistical analysis plan. The trial design and rationale have been previously published. REMAP-CAP is a global adaptive platform trial of patients with severe community-acquired pneumonia (CAP) admitted to the intensive care unit (ICU) that was launched in 2016. This investment establishes important groundwork for future learning health system endeavors. Implementation of the REMAP-COVID trial within a large US healthcare system is feasible and facilitated by multidisciplinary collaboration. Lastly, establishment of a centralized institutional process optimizes coordination of COVID-19 studies. 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. Coordination with the central institutional review board will expedite the approval process. Remote consent and enrollment can be facilitated by engaging bedside providers and leveraging institutional videoconferencing tools. 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.
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We recommend aligning institutional and trial goals and sharing a vision of REMAP-COVID implementation as groundwork for learning health system development. 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. We describe implementation at the first US site, the UPMC health system, and offer recommendations for implementation at other sites. The Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial is a global adaptive platform trial of hospitalized patients with COVID-19.