Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system

Diptesh Aryal, Abi Beane, Arjen M Dondorp, Cameron Green, Rashan Haniffa, Madiha Hashmi, Devachandran Jayakumar, John C Marshall, Colin J McArthur, Srinivas Murthy, Steven A Webb, Subhash P Acharya, Pramodya G P Ishani, Issrah Jawad, Sushil Khanal, Kanchan Koirala, Subekshya Luitel, Upulee Pabasara, Hem Raj Paneru, Ashok Kumar, Shoaib Siddiq Patel, Nagarajan Ramakrishnan, Nawal Salahuddin, Mohiuddin Shaikh, Timo Tolppa, Ishara Udayanga, Zulfiqar Umrani, Diptesh Aryal, Abi Beane, Arjen M Dondorp, Cameron Green, Rashan Haniffa, Madiha Hashmi, Devachandran Jayakumar, John C Marshall, Colin J McArthur, Srinivas Murthy, Steven A Webb, Subhash P Acharya, Pramodya G P Ishani, Issrah Jawad, Sushil Khanal, Kanchan Koirala, Subekshya Luitel, Upulee Pabasara, Hem Raj Paneru, Ashok Kumar, Shoaib Siddiq Patel, Nagarajan Ramakrishnan, Nawal Salahuddin, Mohiuddin Shaikh, Timo Tolppa, Ishara Udayanga, Zulfiqar Umrani

Abstract

The Randomized Embedded Multifactorial Adaptive Platform (REMAP-CAP) adapted for COVID-19) trial is a global adaptive platform trial of hospitalised patients with COVID-19. We describe implementation in three countries under the umbrella of the Wellcome supported Low and Middle Income Country (LMIC) critical care network: Collaboration for Research, Implementation and Training in Asia (CCA). The collaboration sought to overcome known barriers to multi centre-clinical trials in resource-limited settings. Methods described focused on six aspects of implementation: i, Strengthening an existing community of practice; ii, Remote study site recruitment, training and support; iii, Harmonising the REMAP CAP- COVID trial with existing care processes; iv, Embedding REMAP CAP- COVID case report form into the existing CCA registry platform, v, Context specific adaptation and data management; vi, Alignment with existing pandemic and critical care research in the CCA. Methods described here may enable other LMIC sites to participate as equal partners in international critical care trials of urgent public health importance, both during this pandemic and beyond.

Keywords: LMICS; Pandemic; capacity building.; clinical trials; registry platform; research network.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2021 Aryal D et al.

Figures

Figure 1.. Integration of the REMAP trial…
Figure 1.. Integration of the REMAP trial domain specific Case Report Forms (CRF) into the CCA registry.
Figure 2.. CCA team structure and organogram.
Figure 2.. CCA team structure and organogram.
Critical care network: Collaboration for Research, Implementation and Training in Asia team (CCA) structure.
Figure 3.. CCA data platform structure.
Figure 3.. CCA data platform structure.

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Source: PubMed

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