Meeting
EME Programme - Funding Committee Meeting
Date
Tuesday 27th and Wednesday 28th October 2020
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
Professor Arri Coomarasamy
Dr Victoria Cornelius
Ms Anne-Laure Donskoy (public contributor)
Professor Janet Dunn
Professor Daniel Freeman
Dr Amy Gillespie
Professor Jonathan Grigg
Professor Alastair Hay
Dr Mildred Iro - attended between 9.30am - 3pm
Mr Allen Knight (public contributor)
Professor Gregory Lip
Professor Michael Nicholson
Dr Richard Peck
Professor John Petrie
Professor Ruth Plummer
Professor Rustam Salman
Dr Manu Shankar-Hari
Professor John Simpson
Professor Deborah Stocken
Professor Stuart Taylor
Professor Mark Thursz
Professor Chris Weir
Dr Pippa Lewis (Co-opted member - left at 1.30pm)
Secretariat
Dr Andrew Cook
Dr Dani Preedy
Dr Juliana Callaghan
Miss Helen Munday
Dr Elena Harden
Mrs Julie Daniels
Alessandra Wilkinson-Smith
Sue White
Apologies
Professor Iain McInnes
Observers/in attendance
Penny Morton, MRC
Professor Jonathan Seckl, Moncrieff Arnott Professor of Molecular Medicine and Senior Vice Principal of University of Edinburgh - left at 12 noon
Gavin Rudge, RDS, Birmingham
Day 1
Stage 2 Proposals
19/100 EME Researcher Led
NIHR131120 Coles
PARABLE: Proton beAm theRApy in patients with Breast cancer: evaluating early and Late-Effects
Chair: Professor John Norrie
Declared a conflict : Dr Mildred Iro, Professor Danny McAuley
Decision: Recommended to Programme Director to consider fund with changes
19/138 EME Researcher Led
NIHR131082 Murray
APPROACH: Analysis of Proton vs. Photon Radiotherapy in Oligodendroglioma and Assessment of Cognitive Health
Chair: Professor John Norrie
Declared a conflict: Professor Deborah Stocken
Decision: Recommended to Programme Director to consider straight fund
19/144 EME Perinatal Mental Health
NIHR131161 Hirsch
A randomised controlled trial of a web-based early intervention targeting repetitive negative thinking (RNT) in pregnant women: an evaluation of its impact on perinatal anxiety and the mechanism of change
Chair: Professor Eric Alton
Declared a conflict: Dr Manu Shankar-Hari, Professor Janet Dunn, Professor John Norrie
Decision: Recommended to Programme Director to consider fund with changes
19/149 EME Solid Organ Replacement, Transplant and Donation
NIHR130612 Fisher
Extracorporeal Photophoresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK)
Chair: Professor John Norrie
Declared a conflict: Dr Mildred Iro, Professor Chris Weir, Professor Danny McAuley, Professor Eric Alton, Professor John Simpson, Professor Ruth Plummer, Professor Michael Nicholson
Decision: Recommended to Programme Director to consider fund with changes
19/61 Mitigation of the adverse effects of health and social care interventions
NIHR130133 Leff
Primary Radiotherapy And DIEP Flap Reconstruction–II Trial (PRADA-II)
Chair: Professor John Norrie
Declared a conflict: Dr Victoria Cornelius, Professor Eric Alton, Professor Stuart Taylor, Professor Mark Thursz
Decision: Declined
19/100 EME Researcher Led
NIHR131157 Qurashi
GOTHIC2: A multi-centre randomised placebo-controlled trial of glycopyrrolate and hyoscine hydrobromide for the treatment of clozapine-induced hypersalivation
Chair: Professor John Norrie
Declared a conflict: Professor Gregory Lip, Dr Amy Gillespie
Decision: Recommended to Programme Director to consider fund with changes
19/24 EME Researcher Led
NIHR130047 Corrie
A phase II study combining pembrolizumab and olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden
Chair: Professor John Norrie
Declared a conflict: Professor Iain McInnes (not present), Professor Janet Dunn
Decision: Recommended to Programme Director to consider fund with changes
19/100 EME Researcher Led
NIHR131050 Shaw
RAPTOR: Randomised Controlled Trial of PENTOCLO in Mandibular Osteoradionecrosis
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Mildred iro, Professor Gregory Lip, Professor Janet Dunn, Dr Pippa Lewis
Decision: Recommended to Programme Director to consider fund with changes
20/16 Mechanisms of Action of Health Interventions
NIHR132608 Parekh
Mechanistic pathway evaluation of high dose vitamin D3 replacement in adult critically ill patients – EME VITDALIZE UK
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Manu Shankar-Hari, Professor Danny McAuley, Gavin Rudge (observer)
Decision: Declined
20/16 Mechanisms of Action of Health Interventions
NIHR132240 Cook
The ORiF (Operative Rib Fixation) Procedure mEchanisms of Rib fixAtion (OPERA) STUDY
Chair: Professor Eric Alton
Declared a conflict and left the room: Dr Amy Gillespie, Professor Danny McAuley, Professor John Norrie
Decision: Recommended to Programme Director to consider fund with changes
19/119 Mechanisms of Action of Health Interventions
NIHR131600 Scott
Efficacy and Mechanism Evaluation - Effectiveness of Electronic Cigarettes compared with varenicline for smoking cessation in patients with COPD and effect on the Lungs (EME-ECAL study)
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Danny McAuley, Gavin Rudge (observer)
Decision: Recommended to Programme Director to consider straight fund
NIHR131575 Lewis
Evaluating treatment response mechanisms of Rituximab and Tocilizumab in Rheumatoid Arthritis in the R4RA randomised clinical trial
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Richard Peck, Professor Jonathan Grigg
Decision: Recommended to Programme Director to consider fund with changes
Stage 1 Proposals
19/138 EME Researcher Led
NIHR132732 Welsh
A Randomised Phase III Clinical Trial to Investigate the Addition of Mycophenolate Mofetil Up-front to Standard of Care Steroids in the Treatment of Immune Checkpoint Inhibitor Induced Liver Injury (MUST CHECK)
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Janet Dunn, Professor Richard Peck
Decision:Declined
NIHR131798 Hovorka
Closed loop glucose control for inpatients in non-critical care settings (LOOP)
Chair: Professor John Norrie
Declared a conflict and left the room: N/A
Decision:Declined
Manu Shankar-Hari left prior to the start of the discussion
19/137 Bipolar Disorder
NIHR131905 Lobban
The effects of enhancing Bipolar Awareness and Coping (BAC) on personal recovery in people with bipolar: a randomised controlled trial with mediation analysis
Chair: Professor Eric Alton
Declared a conflict and left the room: Professor Iain McInnes (not present), Professor John Norrie
Decision:Declined
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)
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Daniel Freeman
Decision:Shortlisted
NIHR132619 Young
Cognitive Remediation in Bipolar (CRiB2): a randomised trial assessing efficacy and mechanisms
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Amy Gillespie, Professor Daniel Freeman
Decision:Shortlisted
19/153 EME Oral and Dental Health
NIHR132825 D’Aiuto
Treatment of Periodontitis and Arterial Blood Pressure (TOOT) A multicentre, randomized controlled clinical trial
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Amy Gillespie, Professor Iain McInnes (not present), Professor John Petrie, Professor Jonathan Grigg
Decision:Declined
NIHR131965 Grant
Prospective cohort study for detection of periodontal disease in primary care
Chair: Professor John Norrie
Declared a conflict and left the room: Gavin Rudge (observer)
Decision:Declined
Present - Day 2
Professor Danny McAuley (Programme Director -does not vote)
Professor John Norrie (Programme Chair -does not vote)
Professor Eric Alton
Professor Arri Coomarasamy
Dr Victoria Cornelius
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 Michael Nicholson
Dr Richard Peck
Professor John Petrie
Professor Ruth Plummer
Professor Rustam Salman
Dr Manu Shankar-Hari
Professor John Simpson
Professor Deborah Stocken
Professor Stuart Taylor
Professor Mark Thursz
Professor Chris Weir (absent between 10am - 1pm)
Secretariat
Dr Andrew Cook
Dr Dani Preedy
Dr Juliana Callaghan
Miss Helen Munday
Dr Elena Harden
Mrs Julie Daniels
Alessandra Wilkinson-Smith
Sue White
Apologies
Professor Iain McInnes
Dr Mildred iro
Observers/in attendance
Penny Morton, MRC
Manavi Maharahi, RDS, Surrey
Day 2
Stage 1 Proposals
20/04 Building clinical trials experience: Applications to lead an EME-funded clinical efficacy study as part of an NIHR Advanced Fellowship
NIHR131723 Razvi
Triiodothyronine therapy in Heart Failure with reduced ejection fraction (T3-HF)
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Deborah Stocken, Professor John Simpson
Decision:Declined
NIHR131894 Lum
Evaluation of efficacy, outcomes and safety of CD45RO+ memory T cell add-back following CD3 TCR ab/CD19 depleted haematopoietic cell transplantation from an HLA-partially matched donor in paediatric patients with primary immunodeficiencies
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Mildred Iro (not present), Professor Chris Weir, Professor John Simpson
Decision:Declined
NIHR131485 Jones
CTCA Guided Invasive Management versus Standard Invasive Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome: The BYPASS-CTACS study
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Eric Alton, Professor Jonathan Grigg
Decision:Declined
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
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Amy Gillespie, Professor Eric Alton, Professor Mark Thursz
Decision:Shortlisted
NIHR132219 Brown
IMproving accEss To dEvelopmental fOllow up in pReschool chIldren with hearT disEase: The METEORITE study
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Stuart Taylor
Chris Weir left prior to the start of the discussion
Decision:Declined
NIHR132299 Boughton
Closed-loop insulin delivery for people living with Cystic Fibrosis related diabetes (CL4P-CF)
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Michael Nicholson
Decision:Shortlisted
19/136 Evaluation interventions for the diagnosis and treatment of Autoimmune Diseases
NIHR131359 Jones
Disease Modifying Therapy in Primary Biliary Cholangitis (PBC): A New Treatment Paradigm
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Chris Weir (not present), Professor John Simpson, Professor Deborah Stocken
Decision:Shortlisted
NIHR131697 Mankia
Two parallel pilot studies to investigate periodontal intervention in individuals at risk of rheumatoid arthritis (ARRA), and with very early rheumatoid arthritis (VERA)
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Chris Weir (not present), Professor Deborah Stocken
Decision:Declined
NIHR132636 Russell
The PULSES 2 Study: A Step Change In The Way We Treat Critical Hormone Deficiencies To Mimic Biological Processes And Reduce Side Effects
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Alastair Hay, Professor Chris Weir (not present)
Decision:Shortlisted
NIHR132663 Smith
Modulatory effect of low dose IL-2 on reconstituting B cells post rituixmab in ANCA associated vasculitis
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Chris Weir (not present), Professor Michael Nicholson, Professor Richard Peck
Decision:Declined
NIHR132776 Dayan
Can immunointervention delay the onset of T1D in pre-school children? - The UK pre-school T1D prevention study (UK Pre-T1PS)
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Mildred Iro (not present), Dr Amy Gillespie, Professor Alastair Hay, Professor Daniel Freeman
Decision:Declined
19/139 Mitigation of the adverse effects of health and social care interventions
NIHR132780 Pavitt
PROSpECT-PRIOR-2-CHEMO: A phase-3 RCT efficacy, mechanistic & process evaluation of a novel dental intervention PRIOR (Proactive Intensive Oral Review & Treatment) in patients scheduled for chemotherapy for myeloma-ASCT, breast or colorectal cancer to mitigate febrile episodes and oral mucositis
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Chris Weir (not present), Professor Deborah Stocken, Professor Iain McInnes (not present)
Decision:Declined
NIHR132831 Tsui
A Multicentre double-blind randomised trial on remote ischaemic Preconditioning to Improve CArdiovascular and Renal Outcomes (PICARO trial) in Aortic Aneurysm Repair
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Danny McAuley
Decision:Declined
NIHR132839 Lobo
The impact of Immune Modulating-Nutritients on outcomes after gastrointestinal surgery: a blinded randomised controlled trial. (IMAGINE)
Chair: Professor John Norrie
Declared a conflict and left the room: N/A
Decision:Declined
Ruth Plummer left prior to the start of the discussion
19/138 EME Researcher Led
NIHR131988 Brown
MEErKAT MEsenteric Excision and Kono-s Anastomosis Trial
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Chris Weir (not present)
Decision:Shortlisted
NIHR131548 Hopkinson
Dietary nitrate supplementation to enhance daily physical activity in hypoxic COPD: a randomised controlled trial
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Victoria Cornelius, Professor Eric Alton, Professor Mark Thursz
Decision:Shortlisted
NIHR131239 Blagden
Metformin in Li Fraumeni (MILI) trial: A randomised study of Screening plus Metformin versus screening alone in adults with Li Fraumeni Syndrome
Chair: Professor Eric Alton
Declared a conflict and left the room: Dr Amy Gillespie, Professor Chris Weir, Professor John Norrie, Professor Rustam Salman
Decision: Declined – invited to resubmit
Ruth Plummer and Chris Weir re-joined the meeting prior to the start of the discussion
NIHR131758 Hay
Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled trial with qualitative and quantitative investigation of microbial, antibiotic and behavioural mechanisms
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Alastair Hay, Professor Chris Weir
Decision:Shortlisted
Manu Shankar-Hari left prior to the start of the discussion
NIHR131782 Chowdhury
Kidney ALograft Immune Biomarkers of REjection 2 study (KALIBRE-2)
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Manu Shankar-Hari (not present)
Decision:Declined
NIHR131789 Kyle
Targeting insomnia to treat depression: An explanatory randomised controlled trial of sleep restriction therapy
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Mildred Iro (not present), Dr Amy Gillespie, Professor Daniel Freeman
Decision: Shortlisted
Mark Thursz left prior to the start of the discussion
NIHR132019 Gorman
EMERALD: Evaluating Mechanisms and Efficacy of a Remote Assisted Listening Device in mitochondrial disease
Chair: Professor John Norrie
Declared a conflict and left the room: Professor John Simpson
Decision:Shortlisted
NIHR132758 Garway-Heath
Nicotinamide in Glaucoma (NAMinG): a randomised, placebo-controlled, multicentre, Phase III trial
Chair: Professor Danny McAuley
Declared a conflict and left the room: Professor Rustam Salman, Professor John Norrie
Decision: Declined – invited to resubmit
Manu Shankar-Hari re-joined the meeting prior to the start of the discussion
NIHR131386 Walters
Efficacy and predictive mechanisms of the response to farnesoid X receptor agonists in the treatment of primary bile acid diarrhoea
Chair: Professor John Norrie
Declared a conflict and left the room: Professor Eric Alton, Professor Janet Dunn, Professor Mark Thursz (not present), Dr Victoria Cornelius
Decision:Declined – invited to resubmit
NIHR131791 Taylor
The Efficacy of Peroneal Nerve Functional Electrical S Timulation (FES) for the Reduction of Bradykinesia in Parkinson's DiSease: An Assessor Blinded Randomised Controlled Trial (STEPS II)
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Andrew Cook
Decision:Shortlisted
NIHR132753 Cheong
Temperature of embryo culture for assisted Reproduction (PERMIT)
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Andrew Cook, Dr Mildred Iro (not present), Professor Arri Coomarasamy
Decision:Declined
Mark Thursz re-joined the meeting prior to the start of the discussion
NIHR132816 Brownlee
Congenital Anomalies of Kidneys and Urinary Tract (CAKUT) Urinary Tract Inection (UTI) Prophylaxis Trial ('CUP' Trial)
Chair: Professor John Norrie
Declared a conflict and left the room: Dr Andrew Cook, Dr Mildred Iro (not present), Professor Alastair Hay
Decision:Declined
Outcomes Table
Stage 2 Proposals
The EME Funding Committee recommended the following Stage 2 proposals for either immediate funding or for funding subject to certain conditions
Researcher Led
| Project Reference | Lead Applicant | Institution | Project Title |
|---|---|---|---|
| NIHR131120 | Professor Charlotte Coles | Institute of Cancer Research | PARABLE: Proton beAm theRApy in patients with Breast cancer: evaluating early and Late-Effects |
| NIHR131082 | Dr Louise Murray | University of Leeds | APPROACH: Analysis of Proton vs. Photon Radiotherapy in Oligodendroglioma and Assessment of Cognitive Health |
| NIHR131157 | Dr Inti Qurashi | Lancashire Care NHS Foundation Trust | GOTHIC2: A multi-centre randomised placebo-controlled trial of glycopyrrolate and hyoscine hydrobromide for the treatment of clozapine-induced hypersalivation |
| NIHR130047 | Dr Pippa Corrie | Cambridge University Hospitals NHS Foundation Trust | A phase II study combining pembrolizumab and olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden |
| NIHR131050 | Professor Richard Shaw | University of Liverpool | RAPTOR: Randomised Controlled Trial of PENTOCLO in Mandibular Osteoradionecrosis |
| NIHR131600 | Dr Aaron Scott | University of Birmingham | Efficacy and Mechanism Evaluation - Effectiveness of Electronic Cigarettes compared with varenicline for smoking cessation in patients with COPD and effect on the Lungs (EME-ECAL study) |
| NIHR131575 | Dr Myles Lewis | Queen Mary University of London | Evaluating treatment response mechanisms of Rituximab and Tocilizumab in Rheumatoid Arthritis in the R4RA randomised clinical trial |
Commissioned
| Project Reference | Lead Applicant | Institution | Project Title |
|---|---|---|---|
| NIHR131161 | Dr Colette Hirsch | King's College London | A randomised controlled trial of a web-based early intervention targeting repetitive negative thinking (RNT) in pregnant women: an evaluation of its impact on perinatal anxiety and the mechanism of change |
| NIHR130612 | Professor Andrew Fisher | University of Newcastle upon Tyne | Extracorporeal Photophoresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK) |
| NIHR132240 | Associate Professor Jonathan Cook | University of Oxford | The ORiF (Operative Rib Fixation) Procedure mEchanisms of Rib fixAtion (OPERA) STUDY |
Further information on the above projects will be provided on the EME website once the project has started.
Stage 1 Proposals
The following Stage 1 proposals have been shortlisted to submit a Stage 2 application for consideration by the EME Funding Committee at its next meeting
Researcher Led
| Project Reference | Lead Applicant | Institution | Project Title |
|---|---|---|---|
| NIHR131988 | Professor Steven Brown | Sheffield Teaching Hospitals NHS Foundation Trust | MEErKAT MEsenteric Excision and Kono-s Anastomosis Trial |
| NIHR131548 | Dr Nicholas Hopkinson | Imperial College London | Dietary nitrate supplementation to enhance daily physical activity in hypoxic COPD: a randomised controlled trial |
| NIHR131758 | Professor Alastair Hay | NHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group | Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled trial with qualitative and quantitative investigation of microbial, antibiotic and behavioural mechanisms |
| NIHR131789 | Associate Professor Simon Kyle | University of Oxford | Targeting insomnia to treat depression: An explanatory randomised controlled trial of sleep restriction therapy |
| NIHR132019 | Professor Gráinne Gorman | University of Newcastle | EMERALD: Evaluating Mechanisms and Efficacy of a Remote Assisted Listening Device in mitochondrial disease |
| NIHR131791 | Professor Paul Taylor | Salisbury NHS Foundation Trust | The Efficacy of Peroneal Nerve Functional Electrical STimulation (FES) for the Reduction of Bradykinesia in Parkinson’s DiSease: An Assessor Blinded Randomised Controlled Trial (STEPS II) |
Commissioned
| Project Reference | Lead Applicant | Institution | Project Title |
|---|---|---|---|
| NIHR132622 | Dr Sophie Parker | Greater Manchester Mental Health NHS Foundation Trust | 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) |
| NIHR132619 | Professor Allan Young | King's College London | Cognitive Remediation in Bipolar (CRiB2): a randomised trial assessing efficacy and mechanisms |
| NIHR132214 | Dr Dimitrios Koutoukidis | University of Oxford | A low-energy total diet replacement programme with behavioural support for non-alcoholic STeatohepatitis with moderate to Advanced fibRosis: the STAR randomised controlled trial |
| NIHR132299 | Dr Charlotte Boughton | University of Cambridge | Closed-loop insulin delivery for people living with Cystic Fibrosis related diabetes (CL4P-CF) |
| NIHR131359 | Professor David Jones | University of Newcastle upon Tyne | Disease Modifying Therapy in Primary Biliary Cholangitis (PBC): A New Treatment Paradigm |
| NIHR132636 | Dr Georgina Russell | University Hospitals Bristol NHS Foundation Trust | The PULSES 2 Study: A Step Change In The Way We Treat Critical Hormone Deficiencies To Mimic Biological Processes And Reduce Side Effects |