The Clinical Trials Unit (CTU) is part of the research support services clusters of the MRC Unit The Gambia at LSHTM and is a fully fledged ARO/CRO (Academic Research Organisation / Contract Research Organisation) with 20 years of experience providing support to clinical trials including:
- Clinical trials application preparation
- Clinical trial management
- Independent clinical trial monitoring
- Clinical Trial Site management
- Investigational product and samples logistics and accountability
- Trial Master File maintenance
- Local regulatory support
- Pharmacovigilance and reporting of safety events
- GCP and research ethics training for staff involved in clinical research
Mission
We align to the overall core mission of the Unit to encourage and support high-quality research with the aim of improving human health.
CTU in numbers
Current portfolio
We currently have 17 clinical trials in our portfolio.
- Vaccine trials = 8
- Drug trials = 5
- Nutritional trials = 3
- Microneedle patches (medical device) = 1
Total trials
Whilst over the past five years, we have had 29 trials in total.
Therapeutic areas covered:
- Neonatal sepsis and death = 1
- Childhood pneumococcal infection = 2
- Meningitis = 2
- Childhood measles = 1
- Poliomyelitis = 1
- Malaria = 10
- E. Coli diarrhoea = 1
- Immunisation of pregnant women = 2
- Yellow fever = 1
- Human papilloma virus = 1
- Anemia in children = 3
- Micronutrients and brain development = 3
- Gestational diabetes = 1
Phases of trials supported:
- Phase I = 4
- Phase II = 4
- Phase III = 13
- Phase IV = 8
Countries of trials:
- Gambia
- Guinea Bissau
- Burkina Faso
Local and international training activities:
- Certified GCP trainers
- 200 study staff trained in GCP every year
Trial management and independent clinical trial monitoring
- Risk assessment of clinical trials
- Site evaluation and selection
- Onsite and remote interim monitoring
- Trial troubleshooting (low recruitment rates, high dropout rates)
- Management of trials from start to closure
Solutions
- Toolkit with templates and procedures to support development of study plans and essential study documents
- Electronic serious adverse event reporting system to improve pharmacovigilance in trials
- Clinical trial management system to facilitate real-time and risk-based oversight on trial progress
Contact details
For general enquiries:
Email: dct@mrc.gm
MRCG at LSHTM staff in the Clinical Trials Unit.