TY - JOUR
T1 - Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.
AU - Beane, Abi
AU - Aryal, Diptesh
AU - Dondorp, Arjen M.
AU - Green, Cameron
AU - Haniffa, Rashan
AU - Hashmi, Madiha
AU - Jayakumar, Devachandran
AU - Marshall, John C.
AU - McArthur, Colin J.
AU - Murthy, Srinivas
AU - Webb, Steven A.
AU - Acharya, Subhash P.
AU - Ishani, Pramodya G. P.
AU - Jawad, Issrah
AU - Khanal, Sushil
AU - Koirala, Kanchan
AU - Luitel, Subekshya
AU - Pabasara, Upulee
AU - Paneru, Hem Raj
AU - Kumar, Ashok
AU - Patel, Shoaib Siddiq
AU - Ramakrishnan, Nagarajan
AU - Salahuddin, Nawal
AU - Shaikh, Mohiuddin
AU - Tolppa, Timo
AU - Udayanga, Ishara
AU - Umrani, Zulfiqar
N1 - Publisher Copyright: © 2021 Aryal D et al.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Capacity building
KW - Clinical trials
KW - LMICS
KW - Pandemic
KW - Registry platform
KW - Research network
UR - http://www.scopus.com/inward/record.url?scp=85101006065&partnerID=8YFLogxK
U2 - https://doi.org/10.12688/wellcomeopenres.16486.1
DO - https://doi.org/10.12688/wellcomeopenres.16486.1
M3 - Comment/Letter to the editor
C2 - 33604455
SN - 2398-502X
VL - 6
JO - Wellcome Open Research
JF - Wellcome Open Research
M1 - 14
ER -