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EME Funding Committee Minutes February 2021

Contents

Published: 23 March 2021

Version: Version V1.0

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MRC-NIHR funding collaboration

Meeting

EME Programme - Funding Committee Meeting

Date

Tuesday 23rd and Wednesday 24th February 2021

Place

Virtual Meeting

Present - Day 1

Professor Danny McAuley (Programme Director - does not vote)
Professor John Norrie (Programme Chair - does not vote)
Professor Eric Alton (Deputy Chair)
Professor Arri Coomarasamy
Ms Anne-Laure Donskoy (public contributor)
Professor Janet Dunn
Professor Daniel Freeman
Dr Amy Gillespie
Professor Jonathan Grigg
Professor Alastair Hay
Dr Mildred Iro 
Mr Allen Knight (public contributor)
Professor Gregory Lip - until 2pm
Professor Iain McInnes - not available 2pm - 2.30pm
Professor Michael Nicholson
Professor John Petrie
Professor Ruth Plummer
Dr Manu Shankar-Hari - not present around mid-day
Professor John Simpson
Professor Deborah Stocken
Professor Stuart Taylor
Professor Mark Thursz
Professor Chris Weir

Secretariat

Dr Dani Preedy
Dr Andrew Cook
Dr Juliana Callaghan
Miss Helen Munday
Dr Elena Harden
Mrs Julie Daniels
Alessandra Wilkinson-Smith
Sue White

Apologies

Professor Rustam Salman
Dr Richard Peck

Observers/in attendance

Penny Morton, MRC
Martin Hunt - I4I Programme
Hayley Hall - new PPI member from June
Dr Puja Mehta - new TCC member from June
Dr Amy Whitehead, Senior Statistician, RDS 

Stage 2 Proposals

19/138 EME Researcher Led

NIHR131988 Brown
MEErKAT: MEsenteric Excision and Kono-s Anastomosis Trial.
Institution: Sheffield Teaching Hospitals NHS Foundation Trust
Chair: Professor John Norrie
Declared a conflict :
Professor Stuart Taylor, Professor Chris Weir
Decision: Recommended to Programme Director to consider fund with changes

NIHR131789 Kyle
Targeting insomnia to treat depression: An explanatory randomised controlled trial of sleep restriction therapy
Institution: University of Oxford
Chair: Professor John Norrie
Declared a conflict: Professor Daniel Freeman, Dr Amy Gillespie, Amy Whitehead (Observer)
Manu Shankar-Hari left prior to the start of the discussion
Decision: Defer

19/149 EME Solid Organ Replacement, Transplant And Donation

NIHR130899 Giele
Efficacy and mechanism of sentinel skin flap reduction of solid organ transplant rejection: A randomised controlled trial
Institution: University of Oxford
Chair: Professor John Norrie
Declared a conflict: Professor Eric Alton, Dr Mildred Iro, Professor Michael Nicholson, Dr Richard Peck (not present)
Ruth Plummer noted that expertise from Newcastle had been added since the last stage.  It was agreed that this would not prevent her from participating in this section of the meeting
Decision: Recommended to Programme Director to consider fund with changes

20/04 Building clinical trials experience: Applications to lead an EME-funded clinical efficacy study as part of an NIHR Advanced Fellowship Stage 2 proposal

NIHR132214 Koutoukidis
A low-energy total diet replacement programme with behavioural support for non-alcoholic STeatohepatitis with moderate to Advanced fibRosis: the STAR randomised controlled trial
Institution: University of Oxford
Chair: Professor John Norrie
Declared a conflict: Professor Eric Alton, Dr Amy Gillespie, Professor Mark Thursz
Manu Shankar-Hari re-joined the meeting prior to the start of this discussion
Decision: Decline

NIHR132299 Boughton
Closed-loop insulin delivery for people living with Cystic Fibrosis related diabetes (CL4P-CF)
Institution: University of Cambridge
Chair: Dr Andrew Cook
Declared a conflict:
Professor John Norrie, Professor Michael Nicholson, Professor Chris Weir
Decision: Decline – invited to resubmit a stage 2 application

19/138 EME Researcher Led

NIHR131758 Hay
Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled trial with internal pilot and qualitative and quantitative investigation of microbial, behavioural and antibiotic mechanisms (the RAPID-TEST RCT)
Institution: NHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group
Chair: Professor John Norrie
Declared a conflict: Professor Alastair Hay (CI), Professor Chris Weir
Decision: Recommended to Programme Director to consider fund with changes

NIHR132019 Gorman
EMERALD: Evaluating Mechanisms and Efficacy of a Remote Assisted Listening Device in mitochondrial disease
Institution: University of Newcastle
Chair: Professor John Norrie
Declared a conflict: Professor Ruth Plummer, Professor John Simpson
Gregory Lip and Martin Hunt left the meeting prior to the start of this discussion
Decision: Decline

NIHR131548 Hopkinson
Dietary nitrate supplementation to enhance daily physical activity in hypoxic COPD: a randomised controlled trial
Institution: Imperial College London
Chair: Professor John Norrie
Declared a conflict: Professor Eric Alton
Iain McInnes left the meeting prior to the start of this discussion
Decision: Decline - invited to resubmit

19/137 Bipolar Disorder

NIHR132622 Parker
Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): A randomised controlled trial to investigate the efficacy of a treatment approach targeted at key appraisal change (BART II)
Institution: Greater Manchester Mental Health NHS Foundation Trust
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor John Norrie, Professor Daniel Freeman
Iain McInnes returned to the meeting for this discussion and Penny Morton left the meeting
Decision: Recommended to Programme Director to consider fund with changes

NIHR132619 Young
Cognitive Remediation in Bipolar (CRiB2): a randomised trial assessing efficacy and mechanisms
Institution: King's College London
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Daniel Freeman, Dr Amy Gillespie, Professor Manu Shankar-Hari
Penny Morton returned to the meeting during this discussion
Decision: Recommended to Programme Director to consider fund with changtes

20/145 EME Fast Track 2020

NIHR133864 Nunes
Can Nebulised HepArin Reduce Mortality in Patients with SARS-CoV-2? CHARM-CoV Study: A phase II, open-label, randomised controlled trial
Institution: Liverpool University Hospitals NHS Foundation Trust
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Danny McAuley, Professor Chris Weir, Professor Manu Shankar-Hari
Decision: Decline

NIHR133842 Martineau
Vitamin D to enhance immunogenicity and efficacy of SARS-CoV-2 vaccination (CORONAVIT-VAX): longitudinal evaluation nested within an established phase 3 randomised controlled trial
Institution: Queen Mary University of London
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor John Norrie, Professor Arri Coomarasamy, Professor Jonathan Grigg, Professor Rustam Salman (not present), Professor Chris Weir
Decision: Decline

20/13 Mechanisms of Action of Health Interventions

NIHR133388 Reynolds
Infant hypothalamic-pituitary-adrenal axis responses following antenatal corticosteroids and perinatal outcomes: a mechanism of action of health intervention study.
Institution: University of Edinburgh
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor John Norrie, Dr Richard Peck (not present), Professor Rustam Salman (not present), Professor Chris Weir
Decision: Recommended to Programme Director to consider fund with changes

NIHR132974 Kotecha
Neuro-vascular mechanisms of direct oral anticoagulant therapy in younger patients with atrial fibrillation: the DaRe2THINK-NV sub-study
Institution: University of Birmingham
Chair: Professor John Norrie
Declared a conflict and left the room:Professor Gregory Lip (not present)
Decision: Recommended to Programme Director to consider fund with changes

NIHR133079 Chappell
Bp response Assessment BY Pregnancy ANtihypertensive Drug treAtment: (Mechanism of Action of Health Intervention): BABY PANDA study
Institution: King's College London
Chair: Professor Eric Alton
Declared a conflict and left the room:Professor John Norrie, Professor Arri Coomarasamy, Professor Daniel Freeman, Professor Alastair Hay, Professor Manu Shankar-Hari
Decision: Recommended to Programme Director to consider fund with changes

NIHR133318 McPhail
Mechanisms of betablockade on inflammation in patients with portal hypertension
Institution: King's College London
Chair: Professor John Norrie
Declared a conflict and left the room:Professor Manu Shankar-Hari, Professor Mark Thursz
Ruth Plummer left the meeting at the start of the discussion
Decision: Decline

Stage 1 Proposal

20/86 EME Researcher Led

NIHR133169 Majid
Efficacy and mechanism evaluation of transcutaneous vagal nerve stimulation for upper limb recovery post-stroke.
Institution: The University of Sheffield
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Iain McInnes, Professor John Petrie, Professor Chris Weir, Amy Whitehead (observer)
Decision: Shortlist 

 

 

Present - Day 2

Professor Danny McAuley (Programme Director - does not vote)
Professor John Norrie (Programme Chair - does not vote)
Professor Eric Alton (Deputy Chair)
Professor Arri Coomarasamy
Ms Anne-Laure Donskoy (public contributor)
Professor Janet Dunn
Professor Daniel Freeman
Dr Amy Gillespie
Professor Jonathan Grigg
Professor Alastair Hay 
Mr Allen Knight (public contributor)
Professor Gregory Lip 
Professor Iain McInnes - not available between 9am - 12.30pm except for Wilson
Professor Michael Nicholson
Professor John Petrie - not available between 12pm - 1pm
Professor Ruth Plummer
Professor John Simpson
Professor Deborah Stocken
Professor Stuart Taylor
Professor Mark Thursz
Professor Chris Weir

Secretariat

Dr Dani Preedy
Dr Andrew Cook
Dr Juliana Callaghan
Miss Helen Munday
Dr Elena Harden
Mrs Julie Daniels
Alessandra Wilkinson-Smith
Sue White

Apologies

Professor Rustam Salman
Dr Mildred Iro
Dr Richard Peck
Dr Manu Shankar-Hari

Observers/in attendance

Penny Morton, MRC
Dottie Goble, NETSCC
Shaun  Barber, RDS
Hayley Hall, new PPI member from June
Dr Puja Mehta, new TCC member from June 

Stage 1 Proposals

20/86 EME Researcher Led

NIHR133282 Walsh
Central Aspects of Pain in the Knee (CAP-Knee): a personalised medicine tool for knee pain management in osteoarthritis
Institution: The University of Nottingham
Chair: Professor John Norrie
Declared a conflict and left the room: Shaun Barber (observer)
Decision: Decline

NIHR132879 Dunne
A 104-week pragmatic, prospective, randomised, double-blind, parallel-group, placebo-controlled trial of lithium carbonate for the prevention of progression of Alzheimer's disease
Institution: The University of Manchester
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Richard Peck (not present), Professor Chris Weir
Decision: Decline

NIHR133427 Wilson
Fatigue associated with sarcoidosis: a randomised controlled trial of methylphendidate-2 (FAST-MP-2)
Institution: University of East Anglia
Chair: Professor John Norrie
Declared a conflict and left the room: Professor John Simpson, Professor Eric Alton
Iain McInnes joined the meeting prior to the start of the discussion
Decision: 
Decline

NIHR133517 Jha
Vaginal Laser treatment for Genitourinary Syndrome of the Menopause (GSM) following Breast Cancer: Initial feasibility trial followed by double blinded, parallel group, placebo controlled randomised trial of Efficacy
Institution: Sheffield Teaching Hospitals NHS Foundation Trust
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor Janet Dunn, Professor John Norrie
Iain McInnes left the meeting prior to the start of the discussion
Decision: 
Invite resubmission at Stage 1

NIHR133328 Farooq
SALVAGE-DEFER AMI Randomised Controlled Trial Pharmaco-Invasive Deferred Stenting and 'Minimal Touch' Primary PCI During ST-Elevation Myocardial Infarction To Salvage Myocardium Utilising Index-of-Microcirculatory-Resistance as a Tool to Identify Patients with Failed Microvascular Reperfusion
Institution: Cardiff and Vale University Health Board
Chair: Dr Andrew Cook
Declared a conflict and left the room: Professor John Norrie, Professor Iain McInnes (not present), Professor John Petrie, Shaun Barber (observer)
Decision: Shortlist

NIHR133338 Myers
Postnatal enalapril to improve cardiovascular health following preterm pre-eclampsia (PICk-UP2): Multi-centre blinded randomised placebo-controlled parallel-group trial
Institution: Manchester University NHS Foundation Trust
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor John Norrie, Professor Alastair Hay
Decision: Decline

NIHR133606 Lu
Validation of a non-invasive liquid biopsy biomarker - circulating tumour cells, for its role in triaging prostate cancer patients for diagnostic biopsy
Institution: Queen Mary University of London
Chair: Professor Danny McAuley
Declared a conflict and left the room: Professor John Norrie, Professor Michael Nicholson, Professor Ruth Plummer, Professor Stuart Taylor
Decision: 
Decline

20/58 Interventions in Paediatric Care

NIHR133230 Chesler
Liquid Biopsy Testing in Children’s Cancer
Institution: Institute of Cancer Research
Declared a conflict and left the room: N/A
Decision: 
Decline

NIHR133447 Rowe
Out of sight – out of mind: improving visual outcomes for children after acquired brain injury
Institution: University of Liverpool
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Gregory Lip
John Simpson left the meeting prior to the start of the discussion
Decision: 
Shortlist

NIHR133217 Carrol
PROcalcitonin, MR-proADM and PEWS evaluation for Triage of febrile children in the Emergency Department (PROMPT-ED)
Institution: University of Liverpool
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Andrew Cook, Dr Mildred Iro (not present), Dr Richard Peck (not present), Professor Chris Weir
John Simpson re-joined the meeting prior to the start of the discussion
Decision: Decline

NIHR132820 Oni
An efficient phase 3, treatment adaptive, sequential multiple assignment randomised trial (SMART) to evaluate immunosuppressive treatments for IgAV-N (The PINPOINT Trial) with integrated scientific evaluation
Institution: University of Liverpool
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Michael Nicholson, Professor Stuart Taylor, Professor Chris Weir, Professor Gregory Lip, Shaun Barber (observer)
John Petrie left the meeting prior to the start of the discussion
Decision: Shortlist

NIHR133612 Fernandez
NeoCirc UK: multicentre randomized placebo-controlled, double blind trial to investigate the efficacy of dobutamine in the treatment of haemodynamic insufficiency in the immediate postnatal period
Institution: Brighton and Sussex University Hospitals NHS Trust
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Chris Weir
Decision: Decline

20/57 Novel strategies and interventions to reduce overtreatment

NIHR133245 Robson
Withdrawal of Immunosuppression In lupus Nephritis trial: The WIN trial
Institution: King's College London
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Michael Nicholson, Dr Manu Shankar-Hari (not present), Professor Stuart Taylor
John Petrie re-joined the meeting prior to the start of the discussion
Decision: Shortlist

19/138 EME Researcher Led

NIHR131239 Blagden
Metformin in Li Fraumeni (MILI) trial: A randomised study of Screening plus Metformin versus screening alone in adults with Li Fraumeni Syndrome
Institution: University of Oxford
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor John Norrie, Professor Rustam Salman (not present), Professor Stuart Taylor, Professor Chris Weir, Shaun Barber (observer)
Decision: Shortlist

NIHR131386 Walters
Efficacy and predictive mechanisms of the response to farnesoid X receptor agonists in the treatment of primary bile acid diarrhoea
Institution: Imperial College London
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Eric Alton, Professor Janet Dunn, Professor Mark Thursz
Decision: Decline

NIHR132758 Garway-Heath
Nicotinamide in Glaucoma (NAMinG): a randomised, placebo-controlled, multicentre, Phase III trial
Institution: University College London
Chair: Professor John Petrie
Declared a conflict and left the room: Professor John Norrie, Dr Andrew Cook, Professor Rustam Salman (not present)
Decision: Shortlist