Clinical Trials Units
Comprehensive Clinical Trials Unit at UCL
Areas of Research
- Phase 1, 2, 3 and 4
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Members of CCTU have extensive cardiovascular research experience, and we are currently engaged with an active cardiovascular portfolio. We have experience in pharmaceuticals, class III devices, surgical interventions. CCTU is a multidisciplinary trials unit which includes operations, statistics, IT specialists, health economists and quality assurance and regulatory experts. We are part of the UCL Institute of Clinical Trials and Methodology which is the one of the biggest groupings of trial methodologists in the world.
OPTIMAS is a large, prospective, partially blinded randomised controlled trial of early (within ≤4 days [96hrs]) or standard (between day 7 and day 14 after stroke onset) initiation of anticoagulation after stroke in patients with atrial fibrillation (AF), using any licensed dose of a direct oral anticoagulant (DOAC). The trial will use a non-inferiority gatekeeper approach to test for non-inferiority of early anticoagulation followed by a test for superiority, if non-inferiority is established.
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