Clinical Trials Units
Lancashire 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 involving recruitment outside the UK
Sponsorship
We prefer not to take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Lancashire Clinical Trials Unit (CTU) has a well-established track record in co-ordinating multi-centre trials and large complex interventional studies. We offer a full but bespoke service for all trial activities from conception, grant application and trial design including initiation, conduct, monitoring, analysis, reporting, dissemination including publication in peer-reviewed journals. We have led on study design, developing protocols, ethical and regulatory submissions (including producing Consent and Patient Information Sheets, Trial advertising materials, and developing and validating case report forms (CRFs). We develop monitoring plans (both centralised monitoring and site monitoring) using a risk-based approach which is informed by Project Risk Assessments.
Our cardiovascular portfolio includes large multi-site trials (e.g. HeadPoST and CONVINCE), trials with large sample sizes (e.g. HeadPoST (11096), CONVINCE (2623), ICONSII (1200)) and large observational studies (STROLLERS (3240)). We provide all CTU functions (trial management (TM), data management (DM), information systems (IS), statistics (ST) and Quality Assurance and Training (QA&T).
Our interests lie in: Stroke assessment and management; Psychological adjustment; Post-cardiovascular event health, including anxiety, depression, continence and swallowing; Functional recovery including dose finding for therapies to aid functional recovery; Emergency pathways; User involvement; and Needs assessment.
- Head Position in Stroke Trial (HeadPoST 41 UK sites, 5600 UK participants enrolled) https://clinicaltrials.gov/ct2/show/NCT02162017
- Confirming the Mechanism of Motivational Interviewing Therapy after Stroke (COMMITS)
https://www.uclan.ac.uk/research/activity/commits - COlchicine for preventioN of Vascular Inflammation in Non-Cardioembolic strokE (CONVINCE) (UK arm 60+sites) https://www.uclan.ac.uk/research/activity/convince
- IMPROVIng StrokE care India (IMPROVISE) https://uclanglobalhealth.co.uk/
- STROke, Life and LeisurE Research Survey (STROLLERS) https://www.uclan.ac.uk/research/activity/stroke-life-and-leisure-research-survey-strollers
Address: Brook Building, University of Central Lancashire, Preston, PR1 7QR
Email address: lancashirectu@uclan.ac.uk
Website: https://www.uclan.ac.uk/research/activity/lancashire-clinical-trials-unitÂ