Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.
Aryal D., Beane A., Dondorp AM., Green C., Haniffa R., Hashmi M., Jayakumar D., Jayakumar D., Marshall JC., McArthur CJ., Murthy S., Webb SA., Acharya SP., Ishani PGP., Jawad I., Khanal S., Koirala K., Luitel S., Pabasara U., Paneru HR., Kumar A., Patel SS., Ramakrishnan N., Salahuddin N., Shaikh M., Tolppa T., Udayanga I., Umrani Z.
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.