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York Trials Unit

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Areas of Research

  • Phase 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)

Sponsorship

We can take the sponsorship role but have flexibility

Particular areas of interest or experience in cardiovascular trial design and delivery

York Trials Unit has a strong reputation and expertise for doing large pragmatic trials of complex interventions. We have experience of numerous trial designs including: placebo controlled drug trials, open label drug studies, individually randomised pragmatic trials of complex interventions, cluster randomised trials, stepped wedge trials, factorial trials, patient preference trials, randomised consent designs and Trials within Cohorts (TWICS). We have approximately 100 staff and cover all the methodological areas needed for supporting large trials including: statistics, trial co-ordination/management, health economics, data management, Public and Patient Involvement and qualitative research. We are a UKCRC registered clinical trials unit and we are also one of the Royal College of Surgeons registered trials units. Clinically areas where we have supported trials include: surgery, rehabilitation and pre-habilitation, therapist interventions and placebo controlled drug trials. In cardiovascular treatments we have and are supporting trials in wound care (chronic and surgical wounds), cardiac rehabilitation, rapid access chest pain clinics, morphine for patients with chronic heart failure and oxygen for patients with heart failure. For these trials we have undertaken their design, supported their conduct (trial and data management) and undertaken the statistical, health economic and qualitative analysis. We have a close relationship with the Cardiovascular health research group in the Department, which houses the National Audit of Cardiac Rehabilitation (led by Doherty).

  • Hicks, K, Cocks, K, Corbacho Martin, B, Elton, P, MacNab, A, Colecliffe, W & Furze, G 2014, ‘An intervention to reassure patients about test results in rapid access chest pain clinic: a pilot randomised controlled trial’, BMC Cardiovascular Disorders, vol. 14, 138. https://doi.org/10.1186/1471-2261-14-138 ISRCTN60618114
  • Cockayne, S, Pattenden, J, Worthy, G, Richardson, G & Lewin, R 2014, ‘Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomised controlled trial’, International Journal of Nursing Studies, vol. 51, no. 9, pp. 1207-1213. https://doi.org/10.1016/j.ijnurstu.2014.01.010 ISRCTN84692046
  • Clark AL, Johnson M, Fairhurst C, Torgerson D, Cockayne S, Rodgers S, Griffin S, Allgar V, Jones L, Nabb S, Harvey I, Squire I, Murphy J, Greenstone M. Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure. Health Technol Assess. 2015 Sep;19(75):1-120. doi: 10.3310/hta19750 ISRCTN60260702.
  • Lewin RJ, Coulton S, Frizelle DJ, Kaye G, Cox H. A brief cognitive behavioural preimplantation and rehabilitation programme for patients receiving an implantable cardioverter-defibrillator improves physical health and reduces psychological morbidity and unplanned readmissions. Heart 2009;95:63–69. doi:10.1136/hrt.2007.129890 ISRCTN70212111
  • Johnson MJ, Cockayne S, Currow DC, Bell K, Hicks K, Fairhurst C, Gabe R, Torgerson D, Jefferson L, Oxberry S, Ghosh J, Hogg KJ, Murphy J, Allgar V, Cleland JGF, Clark AL. Oral modified release morphine for breathlessness in chronic heart failure: a randomized placebo-controlled trial. ESC Heart Fail. 2019 Dec;6(6):1149-1160. doi: 10.1002/ehf2.12498. Epub 2019 Aug 6. ISRCTN41349358 .

Address: Department of Health Sciences, University of York, York, YO10 5DD

Telephone number: 01904 321726

Email address: sally.baker@york.ac.uk

Website: https://www.york.ac.uk/healthsciences/research/trials/