Clinical Trials Units
Imperial Clinical Trials Unit

Areas of Research
- Phase 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- 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
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Several members of ICTU staff have played major roles in various aspects of the delivery of several late-phase cardiovascular outcomes trials, including ASCOT, ADVANCE, UMPIRE, CREOLE, LEADER, EXSCEL, CLEAR Harmony, ORION 9,10,11, BETonMACE, STRENGTH, SCORED.
Particular expertise lies in translating critical research questions into an optimal design and in the logistical aspects of conducting large randomised trials involving multi-centre and multi-national collaborations. We have extensive experience of serving on DSMBs, end-point committees and steering committees and as global leads which have led to the approvals of novel therapies globally. Leading and conducting large scale registries have helped inform gaps in implementation prioritising and informing future guidelines.
- AARDVARK: Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK. https://clinicaltrials.gov/ct2/show/NCT01118520
- CREOLE: Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans. https://clinicaltrials.gov/ct2/show/NCT02742467
- Da Vinci: EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care. http://www.encepp.eu/encepp/viewResource.htm?id=31479
- ORION 11: Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol. https://clinicaltrials.gov/ct2/show/NCT03400800
- BETonMACE: Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD. https://clinicaltrials.gov/ct2/show/NCT02586155
Address: Imperial College London, 1st Floor, Stadium House, 68 Wood Lane, London W12 7RHÂ
Email address: ictustats@imperial.ac.uk
Website: https://www.imperial.ac.uk/clinical-trials-unit/collaborations/