Clinical Trials Units
Newcastle Clinical Trials Unit
Areas of Research
- Phase 1, 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
We cannot take the sponsorship role
Particular areas of interest or experience in cardiovascular trial design and delivery
We have a substantial track-record in the development and delivery of robust multi-centre surgical and interventional cardiovascular clinical trials; in recent years we have collaborated on 12 trials including phase III trials in minimally invasive cardiac surgery, pilot trials in pre-habilitation, early phase CTIMPS and Phase III/IV trials, as well as reaching across to other specialties, including to oncology in the treatment of cardiotoxicity. We have a track record in device trials across other specialties that is transferable here.
We have recognised expertise and capacity in adaptive trial design (including leading an NIHR-funded project to develop national guidance for resource in adaptive trials), in CTIMPs and in surgical trials, focusing on the most appropriate design for each research question.
Our team, which includes methodologists, biostatisticians, health economists, works with investigators to develop high quality applications for funding and, ultimately, delivers a portfolio of practice-changing trials for patient benefit.
- Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).
- Preventing cardiac damage in patients treated for breast cancer: a phase 3 Randomised, Open label, blinded endpoint, superiority trial of enalapril to prevent Anthracycline-induced CardioToxicity (PROACT)
- Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome: a double-blind, phase II, pilot randomised controlled trial (TACTIC) https://doi.org/10.1186/ISRCTN16613292
- Is pre-habilitation feasible and effective in elderly patients undergoing cardiac surgery? (PrEPS) https://doi.org/10.1186/ISRCTN13860094
- The British Heart Foundation older patients with non-ST SEgmeNt elevatIOn myocaRdial infarction Randomized Interventional TreAtment Trial (SENIOR-RITA) https://clinicaltrials.gov/ct2/show/NCT03052036?term=SENIOR+RITA&cntry=GB&draw=2&rank=1