Clinical Trials Support Group (CTSG)
The Clinical Trials Support Group (CTSG) supports all research activities undertaken in the MORU network. Offering the full spectrum of services to support all aspects of clinical trials development and conduct clinical research functions, CTSG helps plan, implement and manage clinical trial research activities, and ensures compliance with Good Clinical Practice (GCP) and local regulatory ethics committee requirements.
- develops research study documentation such as study protocols, patient information sheets, consent forms and any other documentation that is needed for the study
- Standard Operating Procedures (SOPs) to provide the framework for the research programme
- obtains local regulatory and ethics approvals, monitors clinical trials, provides staff training and project and site management
- designs, sets up, conducts and trains staff in robust data management systems and practises across multi-centred trials
- undertakes complex statistical analyses of data outputs to inform key research conclusions and future study development
CTSG provides crucial support to MORU clinical research sites across South-East Asia and Africa and ensures that each study site – whether a remote community field clinic or an urban hospital – complies with local requirements.
At any given moment, CTSG manages 60-70 active MORU clinical studies including large multi-centre multi-country studies of several thousand subjects. Major studies include:
- The Improving the Radical Cure of Vivax Malaria (IMPROV) trial at seven sites in five countries.
- The Targeting Resistance to Artemisinin Collaboration (TRACII) study, which began in 2015 and is testing the use of triple therapy against the standard dual therapy for malaria as well as exploring the spread of antimalarial resistance in 17 sites in eight countries – Bangladesh, Cambodia, Democratic Republic of Congo (DRC), India, Lao PDR, Myanmar, Thailand and Viet Nam.
- Targeted Malaria Elimination (TME) studies which will evaluate mass drug administration to entire villages in Cambodia, Laos, Myanmar, Thailand and Viet Nam to eliminate malaria. Each TME study site will enrol around 2,000 subjects.