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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.
Highlights
COVID-19 in low- and middle-income countries (LMICs) A truly global pandemic, the COVID-19 pandemic has placed unprecedented strain on national health systems globally, with demand for intensive care beds and mechanical ventilators rapidly outstripping their availability, even in relatively highly resourced settings
Recommendations for supportive therapies are derived mainly from resource-rich settings, whereas recommendations for resource-poor settings in low- and middle-income countries (LMICs), or for rich countries with health systems overwhelmed by the pandemic, are largely lacking2
High quality clinical research, codesigned and conducted in low socio-demographic Index (SDI) countries and in resource constrained LMICS is required in order to discover or verify both the efficacy and effectiveness of treatments in diverse settings
Summary
1. Paul Young, Medical Research Institute of New Zealand, Wellington, New Zealand. 2. Elisabeth Riviello , Beth Israel Deaconess Medical Center, Boston, USA Harvard Medical School, Boston, USA. 3. Michael Lipnick, University of California San Francisco, San Francisco, USA Sky Vanderberg, University of California San Francisco, San Francisco, USA. Keywords Pandemic, clinical trials, research network, registry platform, LMICS, capacity building. Any reports and responses or comments on the article can be found at the end of the article
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