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  • Lancashire Clinical Trials Unit (CTU)

The Lancashire Clinical Trials Unit (CTU) has been set up to manage health related trials for UCLan and external organisations. The Lancashire CTU team has accrued many years of experience in the skills required to develop, manage and analyse clinical trials with a growing specialisation in trials of complex interventions, in particular feasibility trials. The formulation of the Lancashire CTU structure was initiated in 2012 and we are currently supporting national and international trials.

The Lancashire CTU offers a quality assured service for the coordination and delivery of key services pertaining to robust clinical trials of complex interventions and other well designed studies.

 We offer support in:

  • Trial design and developing collaborative applications to funders
  • Trial and site set-up and on-going management, including oversight monitoring
  • Randomisation
  • Data management (including form (CRF) design, data entry and data cleaning)
  • Statistical analysis and reporting

These services are underpinned by our robust quality assurance processes

We specialise in complex intervention trials in the topic areas of:

  • Stroke
  • Midwifery
  • Cancer
  • Musculoskeletal health
  • Public/population health
  • Mental health

We would consider collaborations in other areas of health research.

If you are interested in engaging with the Lancashire Clinical Trials Unit then please apply for our support using the Lancashire CTU request form as early as possible. The completed form should be emailed to lancashirectu@uclan.ac.uk

Lancashire Clinical Trials Unit group photo

Expertise and Subject Areas

  • Trial design and development
  • Feasibility trials
  • Complex intervention trials
  • Trial management
  • Data management
  • Statistics
  • Trial Reporting
  • Research
  • Quality Assurance

Publications

Dey P, Callaghan  M, Cook  N, Sephton  R, Sutton  C, Hough  E, James  J, Saqib  R, Selfe  J (2016) A questionnaire to identify patellofemoral pain in the community: an exploration of measurement properties. BMC Musculoskeletal Disorders; 17:237 DOI: 10.1186/s12891-016-1097-5 View publication

Selfe J, Janssen J, Callaghan M, Witvrouw E, Sutton C J, Richards J, Stokes M, Martin D, Dixon J, Hogarth R, Baltzopoulos B, Ritchie E, Arden N and Dey M P (2016) Are there three main subgroups within the patellofemoral pain population? A detailed characterisation study of 127 patients to help develop targeted Intervention (TIPPs). British Journal of Sports Medicine. ISSN 0306-3674.  In Press. doi: 10.1136/bjsports-2015-094792 View publication

Tyler E, Lobban F, Sutton C, Depp C, Johnson S, Laidlaw K, Jones SH. Feasibility randomised controlled trial of Recovery-focused Cognitive Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA): study protocol. BMJ Open 2016; 6:e010590. doi:10.1136/bmjopen-2015-010590 View publication

Thomas LH, French B, Sutton CJ, Forshaw D, Leathley MJ, Burton CR, Roe B, Cheater FM, Booth J, McColl E, Walker A, Brittain K, Whiteley G, Rodgers H, Barrett J and Watkins CL. (2015) Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care. Programme Grants Appl Res, 3 (1) View publication

Beaver K, Williamson S, Sutton C, Hollingworth W, Gardner A, Allton B, Abdel-Aty M, Blackwood K, Burns S, Curwen D, Ghani R, Keating P, Murray S, Tomlinson A, Walker B, Willett M, Wood N, Martin-Hirsch P (2016) Comparing hospital and telephone follow-up for patients treated for stage–I endometrial cancer (ENDCAT trial): a randomised, multicentre, non-inferiority trial. British Journal of Obstetrics and Gynaecology DOI: 10.1111/1471-0528.14000. View publication

Muñoz-Venturelli P, Arima H, Lavados P, Brunser A, Peng B, Cui L, Song L, Billot L, Boaden E, Hackett M.L, Heritier S, Jan S, Middleton S, Olavarría V.V, Lim J Y, Lindley R.I, Heeley E, Robinson T, Pontes-Neto O, Natsagdorj L, Lin R-T, Watkins C, Anderson C S, and for the HeadPoST Collaborative Investigators (2015). Head Position in Stroke Trial (HeadPoST) – sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial. Trials, 16, 256. View publication

Radford, Kathryn A, Phillips, Julie, Jones, Trevor, Gibson, Ali, Sutton, Chris J, Watkins, Caroline Leigh, Sach, Tracey, Duley, Lelia, Walker, Marian, Drummond, Avril, Hoffman, Karen, O'Connor, Rory, Forshaw, Denise and Shakespeare, David (2015) Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial. Pilot and Feasibility Studies, 1, 24. View publication

Chesworth, Brigit, Leathley, Michael John, Thomas, Lois Helene, Sutton, Chris J, Forshaw, Denise and Watkins, Caroline Leigh (2015) Assessing fidelity to treatment delivery in the ICONS (Identifying Continence OptioNs after Stroke) cluster randomised feasibility trial. BMC Medical Research Methodology, 15, 68. ISSN 1471-2288 View publication

The AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial (2015) The Lancet 2015; 386(9988):46-55 View publication

Lois H Thomas, Caroline L Watkins, Beverley French, Christopher Sutton, Denise Forshaw, Francine Cheater, Brenda Roe, Michael J Leathley, Christopher Burton, Elaine McColl and Jo Booth for The ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups (2011) Study protocol: ICONS: Identifying continence options after stroke: A randomised trial. Trials 12: 131. View publication

 

Events and News

2017 

21st March 2017
CRN Support for Trials Seminar, Adelphi Building

30th March 2017
Lancashire CTU training day, Legacy Hotel

2016 

22nd November 2016
Lancashire CTU training day Adelphi Building, University of Central Lancashire

14th September 2016
Good Clinical Practice (GCP) Training

12th July 2016The Health and wellbeing Research Methodology and Implementation (HeRMI) seminar, 12th July 2016 "Trial Site selection: Engaging clinical staff in complex interventions" by Denise Forshaw, Principal Clinical Trials Manager.

2015

15 February 2015
Lancashire CTU training day, Westleigh Conference Centre, University of Central Lancashire

2014

September 2014
Role of emergency care staff in managing acute stroke

18 June 2014
Stroke nurses to take part in global trial of patient positioning policies. (Nursing Standard)

16 June 2014
University hosts county’s new clinical trials unit

12 June 2014
UCLan launches Lancashire’s first Clinical Trials Unit

12 June 2014
Lancashire Clinical Trials Unit Launch Event

Members

Directors

Prof Dame Caroline Watkins (Director)
Dr Chris Sutton (Associate Director Operations / Principal Statistician)

Trial Management

Denise Forshaw (Principal Clinical Trials Manager)
Joanna Cox (Clinical Trials Manager)
Jane Fitzgerald (Senior Trials Assistant)
John Heney (Senior Trials Assistant)

Trial Design and Statistical Analysis

Dr Chris Sutton (Principal Statistician)
Svetlana Tishkovskaya (Lecturer in Health Statistics)
Dr Rasiah Thayakaran (Lecturer in Health Statistics)
Dr Helene Thygesen (Lecturer in Health Statistics)
Dr Phillip Gichuru (Senior Statistical Assistant)

Information Systems and Data Management

Alison Hadley (Data Co-ordinator)
Glenn Holt (Senior Clinical IS Assistant)

 

Quality Assurance

George Georgiou (Quality Assurance and Training Manager)

Administration

Carole Bruce
Carole joined UCLan in October 2015 and supports the Lancashire Clinical Trials Unit in an administration and data handling role. Carole has completed her Data Entry Clerk training, and has extensive administration experience gained through her information analyst role within the military.

Alison Gibbon
Alison joined UCLan in October 2015 and supports the Lancashire Clinical Trials Unit in an administration and data handling role. Alison has completed her Data Entry Clerk training, and has experience in a variety of administration and clerical roles.

Helen Byfield
Helen has supported the Lancashire Clinical TrialS Unit since August 2015. Her role centres around the organisation of a number of Lancashire Clinical Trials Unit meetings. 

Rosemary Horan
Rosemary has supported the Lancashire Clinical Trial Unit since August 2015. Her role centres around the organisation of a number of Lancashire Clinical Trials Unit meetings.

Simone Finley (Senior Associate Research Officer)

Simone provides senior administrative support to the Lancashire Clinical Trials Unit. Simone has worked in administration for 16 years and has a vast amount of knowledge in this area including developing and delivering administrative processes, support in recruitment of staff, data entry, data extraction, conference organisation, monitoring funding and producing reports and supervision of clerical staff.

Dr Hayley Tyrer 

 

 

 

Projects

Current projects

 

Completed Projects