Staff Profile
Nicola Goudie
Senior Trial Manager
- Email: nicola.goudie@ncl.ac.uk
- Address: Newcastle Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
I am a Senior Trial Manager within the Newcastle Clinical Trials Unit (NCTU). I currently work on the following clinical Trials:
- Can interferon gamma prevent infection in critically ill patients at highest risk? A phase II randomised controlled trial (INFINIT)
- Extracorporeal Photopheresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK)
- Extracorporeal Photopheresis in the treatment of Chronic Lung Allograft Dysfunction: Long-Term Follow-Up Study (E-CLAD UK Long-term)
- A single-centre, experimental medicine study investigating the route of delivery and potential efficacy of autologous tolerogenic dendritic cell (TolDC) therapy for Rheumatoid Arthritis (AuToDeCRA-2)
- A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months (MultICath)
As a Senior Trial Manager I support researchers with the set-up, conduct and close-down of single-centre and multi-centre research trials. During my time at NCTU I have worked on a variety of trial types including CTIMP and Surgical trials. I have also worked on trials based within a variety of clinical specialties.
I have worked at NCTU since December 2014, starting as an Assistant Trial Manager before progressing to Trial Manger in June 2015, Acting Senior Trial Manager in September 2022 and Senior Trial Manager in June 2023. Prior to working within the NCTU I worked within the R&D Departments at The Newcastle upon Tyne Hospitals NHS Foundation Trust and Tees, Esk and Wear Valleys NHS Foundation Trust. I have worked in research since December 2009.
Since October 2013 I have also held the role of GCP Facilitator within the North East and North Cumbria LCRN. As a GCP Facilitator I am involved in the delivery of GCP Training courses to staff involved in research across the North East and North Cumbria region.
Current Trials:
- Can interferon gamma prevent infection in critically ill patients at highest risk? A phase II randomised controlled trial (INFINIT)
- Extracorporeal Photopheresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK)
- Extracorporeal Photopheresis in the treatment of Chronic Lung Allograft Dysfunction: Long-Term Follow-Up Study (E-CLAD UK Long-term)
- A single-centre, experimental medicine study investigating the route of delivery and potential efficacy of autologous tolerogenic dendritic cell (TolDC) therapy for Rheumatoid Arthritis (AuToDeCRA-2)
- A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months (MultICath)
Previous Trials:
- A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (PAX-BD)
- Preoperative Behavioural Intervention to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS)
- The National Trial of Tonsillectomy in Adults: a clinical and cost effectiveness study (NATTINA)
- Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT)
- A Randomized Controlled Trial of Intensive Versus Standard Physical Rehabilitation Therapy in the Critically Ill (Extra Physiotherapy In Critical Care) (EPICC)
- A randomised controlled pilot trial of Losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis (anti-Fibrotic Effects of Losartan In NASH Evaluation study) (FELINE)
- EMesis in Pregnancy - Ondansetron With mEtoclopRamide (EMPOWER)
- Long-term Safety and Efficacy Study of Deferiprone in Patients with Pantothenate Kinase-Associated Neurodegeneration (PKAN) (TIRCON2012V1-EXT)
- A randomized, double-blind, placebo-controlled trial of deferiprone in patients with pantothenate kinase-associated neurodegeneration (PKAN) (TIRCON2012V1)
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Articles
- Fisher AJ, Carby M, Thompson R, Parmar J, Alaloul M, Santhanakrishnan K, Hancock H, Wason J, Grayling M, Hasenfuss J, Lally J, Gennery A, Exley C, Lordan J, Bradley P, Flinn A, Bardgett M, White M, Goudie N, Phillipson J, Kershaw A, Smith H, Russell S, Vale L, Chadwick T, Bryant A, Bevin-Nicholls A, Frisby L, Johnson R. Extracorporeal Photopheresis (ECP) in the Treatment of Chronic Lung Allograft Dysfunction (CLAD): a prospective, multicentre, open-label, randomised controlled trial studying the addition of ECP to standard care in the treatment of bilateral lung transplant patients with CLAD (E-CLAD UK). BMJ Open Respiratory Research 2024, 11(1), e001995.
- Azim L, Hindmarch P, Browne G, Chadwick T, Clare E, Courtney P, Dixon L, Duffelen N, Fouweather T, Geddes JR, Goudie N, Harvey S, Helter T, Holstein EM, Martin G, Mawson P, McCaffery J, Morriss R, Simon J, Smith D, Stokes P, Walker J, Weetman C, Wolstenhulme F, Young AH, Watson S, McAllister-Williams H. Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study). BMC Psychiatry 2021, 21(21), 334.
- Robson S, McParlin C, Mossop H, Lie M, Fernandez-Garcia C, Howel D, Graham R, Ternent L, Steel A, Goudie N, Nadeem A, Phillipson J, Shehmar M, Simpson N, Tuffnell D, Campbell I, Williams R, O'Hara ME, McColl E, Nelson-Piercy C. Ondansetron and metoclopramide as second-line antiemetics in women with nausea and vomiting in pregnancy: The empower pilot FACTORIAL RCT. Health Technology Assessment 2021, 25(63), VII-78.
- Snowden C, Lynch E, Avery L, Haighton C, Howel D, Mamasoula V, Gilvarry E, McColl E, Prentis J, Gerrand C, Steel A, Goudie N, Howe N, Kaner E. Preoperative behavioural intervention to reduce drinking before elective orthopaedic surgery: the PRE-OP BIRDS feasibility RCT. Health Technology Assessment 2020, 24(12), 1-176.
- Snowden CP, Lynch E, Avery L, Gerrand C, Gilvarry E, Goudie N, Haighton C, Hall L, Howe N, Howell D, McColl E, Prentis J, Stamp E, Kaner E. Preoperative Behavioural Intervention versus standard care to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS): Protocol for a multicentre pilot randomised controlled trial. Pilot and Feasibility Studies 2018, 4(140).
- McPherson S, Wilkinson N, Tiniakos D, Wilkinson J, Burt AD, McColl E, Stocken DD, Steen N, Barnes J, Goudie N, Stewart S, Bury Y, Mann D, Anstee QM, Day CP. A randomised controlled trial of losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis. PLoS One 2017, 12(4), e0175717.