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Clinical Trials Unit

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. 

MRCG at LSHTM staff in the Clinical Trials Unit