Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and...

Area of Science:

• Critical Care Medicine
• Infectious Diseases
• Clinical Trial Methodology

Background:

• The COVID-19 pandemic highlighted the need for global participation in clinical trials.
• Low- and middle-income countries (LMICs) face unique challenges in participating in multi-center trials.
• Existing networks like the Collaboration for Research, Implementation and Training in Asia (CCA) offer a framework for addressing these challenges.

Purpose of the Study:

• To describe the implementation strategies for the Randomized Embedded Multifactorial Adaptive Platform (REMAP-CAP) trial adapted for COVID-19 in LMIC settings.
• To detail methods used by the CCA network to overcome barriers to multi-center clinical trial participation in resource-limited settings.
• To enable equitable LMIC involvement in international critical care research.

Main Methods:

• Strengthening existing communities of practice.
• Implementing remote study site recruitment, training, and support.
• Harmonizing trial protocols with existing care pathways and registry platforms.
• Adapting data management for specific contexts.
• Aligning with existing pandemic and critical care research initiatives.

Main Results:

• Successful adaptation and implementation of the REMAP-CAP COVID-19 trial in three LMIC countries.
• Demonstrated feasibility of overcoming common barriers in resource-limited settings.
• Established a model for effective collaboration between international researchers and LMIC sites.

Conclusions:

• The described methods facilitate the participation of LMIC sites as equal partners in international critical care trials.
• This approach enhances global capacity for conducting urgent public health research during pandemics and beyond.
• Strengthened collaboration is key to equitable global health research participation.