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