Here are the Efficacy and Mechanism Evaluation (EME) Funding Committee minutes from November 2023.
Day 1 - Tuesday 7 November 2023
Venue
The Danubius Hotel, 18 Lodge Rd, London, NW8 7JT
Present members
- Danny McAuley (Programme Director)
- John Norrie (Chair)
- Maya Buch (Deputy Chair)
- Victoria Allgar
- James Burton
- Vicky Coyle
- Rob Forsyth
- Daniel Freeman
- Rajna Golubic (Committee Member Development Scheme)
- Hayley Hall (Public Committee Member)
- Alastair Hay
- Chandrika Kakiraj (Public Committee Member)
- Patricia Limousin
- Gerry McCann
- Ronan McMullan
- Brian Nicholson
- Nuru Noor (Committee Member Development Scheme)
- Philip Pallmann
- Don Sharkey
- John Simpson
- Deborah Stocken
- David Talbot (Public Committee Member)
- Stuart Taylor
Secretariat
- Andrew Cook
- Debbie Willis
- Helen Munday
- Elena Harden
- Sam Newman
- Jo Oakley
Apologies
- Alun Bedding
- George Hanna
- David Jones
- Manu Shankar-Hari
- Florence Theberge, MRC
Quoracy information
- Voting members: 26 (Quoracy = 66% = 17.3)
- Voting members present on Day 1: 22 = 85%
Stage 2 applications
22/159 EME Programme Researcher-led
NIHR157655 - Microsurgical prophylactic lymphatic vessels anastomosis to reduce risk of lymphoedema (CRYPTIC trial)
Chair: John Norrie
Conflicts: None
Decision: Decline
NIHR158535 - DEXmedetomidine Trial of Adjunct Treatment with Morphine (DEXTA): a masked, randomised placebo-controlled trial
Chair: John Norrie
Conflicts: Don Sharkey, James Burton, Andrew Cook
Decision: Recommended to Programme Director to consider Fund with Changes
NIHR158620 - A randomised controlled trial of prevention of acute muscle wasting in critically ill adults with ketogenic feeding: the Alternative Substrates In the Critically Ill Subject II (ASICS-II)
Chair: John Norrie
Conflicts: Danny McAuley
Decision: Recommended to Programme Director to consider Fund with Changes
22/110 EME Programme Researcher-led
NIHR156271 - Faecal Transplantation for Alcohol-Related Hepatitis
Chair: John Norrie
Conflicts: Danny McAuley, Victoria Allgar
Decision: Recommended to Programme Director to consider Fund with Changes
22/564 Evaluating the efficacy of metformin in tuberous sclerosis complex
NIHR159386 - A double blind randomised placebo controlled trial of metformin in refractory epilepsies associated with tuberous sclerosis complex (MiTS2)
Chair: John Norrie
Conflicts: Patricia Limousin
Decision: Decline – invited to resubmit Stage 2 application
23/16 A platform trial to evaluate potential interventions in dementia
NIHR159446 - A Multi-Arm, multi-Stage trial platform for dementia and mild cognitive impairment due to Alzheimer's Disease (MASTODON-AD)
Chair: Maya Buch
Conflicts: Nuru Noor, Daniel Freeman, John Simpson, John Norrie, Rajna Golubic
Decision: Decline - recommended for Application Development Award
23/15 Precision medicine platform studies to efficiently evaluate the efficacy of interventions
NIHR158714 - Precision medicine Adaptive Network platform Trial in Hypoxemic acutE respiratory failuRe (PANTHER)
Chair: Maya Buch
Conflicts: John Norrie, Manu Shankar-Hari, Alastair Hay, Vicky Coyle, John Simpson, Ronan McMullan, Danny McAuley, George Hanna, Brian Nicholson, Stuart Taylor, John Norrie, Gerry McCann
Decision: Recommended to Programme Director to consider Fund with Changes
22/557 Palliative and end of life care (EME Programme)
NIHR159167 - A cluster randomized controlled trial of online Acceptance and Commitment Therapy (ACT) training to improve mental wellbeing in staff caring for terminally ill people and their caregivers
Chair: Maya Buch
Conflicts: John Norrie, Gerry McCann, Danny McAuley
Decision: Recommended to Programme Director to consider Fund with Changes
22/160 NIHR NICE rolling call (EME Programme: December '22 - April '23)
NIHR158852 - Investigating the efficacy of neuromuscular electrical stimulation as a therapy for sarcopenia in people on maintenance haemodialysis
Chair: Maya Buch
Conflicts: John Norrie, James Burton, Gerry McCann
Decision: Recommended to Programme Director to consider Fund with Changes
22/105 NIHR James Lind Alliance Priority Setting Partnerships rolling call (EME Programme: August - December '22)
NIHR156766 - CESAR: Contrast Enhanced mammography versus magnetic reSonace imaging for Assessing Response to neoadjuvant chemotherapy
Chair: John Norrie
Conflicts: None
Decision: Recommended to Programme Director to consider Fund with Changes
NIHR156754 - Efficacy of mirror movement therapy for improved recovery of ankle neuromuscular control after stroke: MMT-ankle Trial
Chair: John Norrie
Conflicts: None
Decision: Decline
23/92 EME Application Development Award – Industry engagement for a phase 2 pre-licence platform to evaluate pharmaceutical and digital interventions for obesity
NIHR161887 - Creating a Phase 2 Trials Platform for Obesity Therapies in the UK
Chair: John Norrie
Conflicts: Daniel Freeman, Stuart Taylor, James Burton, Brian Nicholson, Gerry McCann, Alastair Hay
Decision: Recommended to Programme Director to consider Fund with Changes
NIHR162393 - Adaptive Trials of Obesity Medicines and Interventions Consortium (ATOMIC)
Chair: John Norrie
Conflicts: Philip Pallmann, Brian Nicholson, Rajna Golubic
Decision: Recommended to Programme Director to consider Fund with Changes
Day 2 - Wednesday 8 November 2023
Present members
- Danny McAuley (Programme Director)
- John Norrie (Chair)
- Maya Buch (Deputy Chair)
- Victoria Allgar
- James Burton
- Vicky Coyle
- Rob Forsyth
- Daniel Freeman
- Rajna Golubic (Committee Member Development Scheme)
- Hayley Hall (Public Committee Member)
- George Hanna
- Alastair Hay
- Chandrika Kakiraj (Public Committee Member)
- Patricia Limousin
- Gerry McCann
- Ronan McMullan
- Brian Nicholson
- Nuru Noor (Committee Member Development Scheme)
- Philip Pallmann
- Don Sharkey
- John Simpson
- Deborah Stocken
- David Talbot (Public Committee Member)
- Stuart Taylor
Secretariat
- Andrew Cook
- Debbie Willis
- Helen Munday
- Elena Harden
- Sam Newman
- Jo Oakley
Apologies
- Alun Bedding
- David Jones
- Manu Shankar-Hari
- Florence Theberge, MRC
Quoracy information
- Voting members: 26 (Quoracy = 66% = 17.3)
- Voting members present on Day 2: 23 = 85%
Stage 1 applications
23/57 EME Programme Researcher-led
NIHR161847 - The effect of co-enzyme Q10 supplementation on functional, physiological and metabolic biomarkers in people with heart failure with reduced ejection fraction: a mechanistic sub-study within a randomised controlled trial (CORAL mechanistic)
Chair: John Norrie
Conflicts: Alastair Hay, Vicky Coyle, Philip Pallmann
Decision: Shortlist
NIHR161200 - CLOTBUST-L: An open-label, multicentre, randomised controlled trial to evaluate the efficacy of ex situ fibrinolysis during normothermic perfusion in liver transplantation from donation after circulatory death donors
Chair: John Norrie
Conflicts: David Jones, John Simpson
Decision: Shortlist
22/159 EME Programme Researcher-led
NIHR158537 - Rest Or Moderate Mechanical Ventilation During ECMO Support - ROMEO
Chair: Maya Buch
Conflicts: Alastair Hay, Vicky Coyle, Danny McAuley, John Simpson, Ronan McMullan, George Hanna, John Norrie, Brian Nicholson
Decision: Shortlist
23/57 EME Programme Researcher-led
NIHR161509 - A Double-blind, Sham-controlled Randomised Controlled Trial Of Home-based Transcranial Random Noise Stimulation (tRNS) For Children With ADHD
Chair: John Norrie
Conflicts: Andrew Cook
Decision: Decline
NIHR160881 - TheRapIes for chronic or relaPsing cOviD-19 (TRIPOD)
Chair: John Norrie
Conflicts: Patricia Limousin, Deborah Stocken, Andrew Cook
Decision: Decline
23/56 Palliative and end of life care (EME Programme)
NIHR160574 - Energise - A Randomised Trial of an Exercise and Nutrition Based Rehabilitation Intervention in People Living With Cancer
Chair: Maya Buch
Conflicts: John Norrie, Andrew Cook
Decision: Decline - invite application for Development Award Funding
23/57 EME Programme Researcher-led
NIHR160829 - Edmond J. Safra Parkinson’s Disease Multi-Arm Multi-Stage Trial Platform
Chair: John Norrie
Conflicts: Victoria Allgar, Nuru Noor, Patricia Limousin
Decision: Shortlist
NIHR160933 - A multi-centre, double-blind, placebo-controlled randomised trial comparing a combination of methotrexate and mifepristone versus methotrexate alone as a medical treatment for tubal ectopic pregnancy (Short title - AMETHYST Trial: Adding Mifepristone to mETHotrexate for ectopic pregnancY STudy)
Chair: Maya Buch
Conflicts: John Norrie, John Simpson, Don Sharkey
Decision: Shortlist
NIHR160358 - Prevention Of Dementia and Cognitive decline After non-lacunar ischaemic Stroke in patients with cerebral Small vessel disease Trial-2 (PODCASST-2)
Chair: Maya Buch
Conflicts: Don Sharkey, John Norrie, James Burton
Decision: Decline
NIHR161675 - ARAGON: Antibiotic Repurposing for Alternative GONococcal treatment
Chair: John Norrie
Conflicts: None
Decision: Decline
23/79 Evaluation of technologies and interventions in primary care settings
NIHR160496 - Determining the clinical efficacy of positive mood and/or vitamin D as adjuvants for influenza vaccines in older adults
Chair: John Norrie
Conflicts: Andrew Cook, Alastair Hay, Brian Nicholson, Philip Pallmann, Don Sharkey
Decision: Decline
23/53 Body fluid-based biomarkers in traumatic brain injury (EME Programme)
NIHR159241 - Biomarkers for RAtional Investigation for Neurological decision Support in TBI: BRaINS-TBI
Chair: John Norrie
Conflicts: Ronan McMullan, Deborah Stocken, Danny McAuley
Decision: Shortlist
NIHR161450 - Investigating the Clinical Utility of Biomarkers in the pre-hospital Evaluation of traumatic brain injury (CUBE)
Chair: John Norrie
Conflicts: Ronan McMullan, Deborah Stocken, Danny McAuley, Rajna Golubic
Decision: Decline
NIHR161839 - CLARIFY TBI: CLinical Assessment of biomaRkers In Fluid to stratifY longterm outcomes after Traumatic Brain Injury
Chair: John Norrie
Conflicts: None
Decision: Shortlist
23/79 Evaluation of technologies and interventions in primary care settings
NIHR160789 - Daridorexant as adjuvant treatment for people with depression experiencing insomnia (DREAM-DI): decentralised, multicentre, individually randomised, double-blinded, placebo-controlled superiority trial
Chair: John Norrie
Conflicts: Alastair Hay, Victoria Allgar, Rajna Golubic
Decision: Decline
NIHR160513 - A randomised controlled trial evaluating the efficacy and mechanisms of eye movement desensitisation and reprocessing therapy (EMDR) compared with treatment as usual for adults with depression in primary care
Chair: John Norrie
Conflicts: Andrew Cook, Alastair Hay
Decision: Shortlist
22/159 EME Programme Researcher-led
NIHR158636 - Trauma-focused therapy in early psychosis: A randomised controlled trial assessing the efficacy and mechanisms of action of Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) in comparison to treatment as usual in Early Intervention settings
Chair: Maya Buch
Conflicts: Daniel Freeman, John Norrie
Decision: Shortlist
23/59 NIHR NICE rolling call (EME Programme: April - August '23)
NIHR160718 - Optimising Vancomycin Dosing for Clostridioides difficile Infection (OVID-CDI)
Chair: John Norrie
Conflicts: Brian Nicholson, Philip Pallmann, Deborah Stocken, Victoria Allgar
Decision: Decline
23/58 NIHR James Lind Alliance Priority Setting Partnerships rolling call (EME Programme: April - August '23)
NIHR160723 - Randomised control trial of conventional treatment versus early pulmonary valve replacement for asymptomatic patients with repaired Tetralogy of Fallot and severe pulmonary regurgitation
Chair: John Norrie
Conflicts: Alastair Hay
Decision: Decline