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10/04/2023
Research Funding: a view from the Efficacy and Mechanism Evaluation (EME) Programme
Dr Lisa Douet, Senior Research Fellow and
Ellie Monks, Programme Manager
Efficacy and Mechanism Evaluation Programme
Aim:• Support excellent clinical science with an ultimate view to improving
health or patient care
Dual Approach:• “Science driven” – examine the efficacy of a technology intervention
(i.e. pharmaceutical, diagnostic test, surgical or psychological therapies, or public health measures) and/or explore its mechanisms of action
• Clear patient focussed outcomes in areas of need for health care research
Efficacy and Mechanism Evaluation Programme
Managed Translational Pathway
Efficacy and Mechanism Evaluation Programme
• In simple terms:
MRC: can it work?
EME: does it work?
HTA: is it worth it?
• There is opportunity for pull through of research, but also for push back (reverse translation) when necessary
Translating science into better health
Efficacy and Mechanism Evaluation Programme
• Two funding streams
MRC funded, largely researcher led, but with an eye to MRC strategy and priorities
NIHR funded, for commissioned research into priority areas
• Same broad remit
To support clinical trials and studies which: • evaluate clinical efficacy of healthcare interventions (drugs,
technology, diagnostics, procedures) • may add significantly to our understanding of biological or
behavioural mechanisms and processes; • explore new scientific or clinical principles.
Overview of EME
Efficacy and Mechanism Evaluation Programme
• Standard mode (two stage application)On going call with 3 closing dates a yearPreliminary application submission deadline to funding decision around 8 months
• Fast track (single stage application)Reduces time to funding decision by ~ 3 monthsAllowed in exceptional circumstances where reducing the timescale will:
• provide significant benefit, • allow exploitation of a narrow window of opportunity
Mechanisms of working: researcher-led work stream
Efficacy and Mechanism Evaluation Programme
• Applications must have a strong collaborative approach and include significant contributions from at least two of the following partners: industry, academia and the NHS.
• Proposals should focus on a clinical study which is within the remit of the EME programme but may be staged and include earlier stages, such as:
• the limited steps needed to progress the development of an intervention to a stage suitable for use in an accredited clinical service
• prospective clinical work or retrospective research utilising existing clinical samples or data to inform the main study
• pilot or feasibility studies • As a rough guide it is expected that these early stages will be
complete within the first 18 months of the project and contribute approximately 25% to the total cost of the project.
Mechanisms of working: commissioned work stream
Efficacy and Mechanism Evaluation Programme
• Current calls – close 3 February 2014• non-respiratory sleep disorders• autism spectrum disorders• active implantable medical devices• mechanisms of action of bariatric surgery• microbial therapies to treat gastrointestinal disease • passive and bioactive implantable devices (close 3 June 2014)
On-going call opening 2013 – Mechanisms of action of health interventions• For further details about these calls, including the detailed commissioning
brief please see the EME website www.eme.ac.uk/funding/Commissioning.asp
Current EME commissioned calls
Efficacy and Mechanism Evaluation Programme
• Future calls• Opening February 2014 – self-harm and suicidal behaviours
• Opening June 2014 – bowel control and faecal incontinence in adults and wound healing
• Opening October 2014 – endoscopic and laparoscopic optical imaging
Please check the EME website for further details on each call and for up to date information on call timings
www.eme.ac.uk/funding/Commissioning.asp
Future EME commissioned calls
Efficacy and Mechanism Evaluation Programme
• Since April 2008 the EME Board has approved funding for 57 researcher led studies (subject to contract)
• Since January 2012 the EME Board has approved funding for 20 commissioned studies (subject to contract)
• The funding projects have received ranges from £0.12 to £3.1 million, and durations range from 18 to 66 months
• Projects cover a broad range of disease areas and interventions
Funded studies
Efficacy and Mechanism Evaluation Programme
Examples of Funded studies Researcher-led
Remote ischaemic preconditioning in renal transplantation
Professor Raymond MacAllister (University College London) 42 months from 1st July 2009 (£818,263)
Aims to determine if remote ischaemic preconditioning improves renal function after transplantation
A randomised double-blind placebo controlled Phase 2B clinical trial of repeated application of gene therapy in patients with Cystic Fibrosis.
Professor Eric Alton (Imperial College, London) 24 months from 1st March 2012 (£3,073,905).
Aims assess the clinical benefit of repeated doses of gene therapy (pGM169/GL67A) administered to the lungs of patients with CF over a period of 48 weeks
Efficacy and Mechanism Evaluation Programme
Top 10 reasons for rejection
Reason for rejection Rank Order
Trial design issues 1Poorly written application/ case for trial needed to be stronger 2Sample size/power calculation/stats issues 3Justification of end point measurements 4Justification of costs of required 5Lack preliminary data 6Recruitment issues (including drop rates and recruitment targets) 7Issues relating to the selection of patients/population chosen 8
Lack of inclusion of CTU/statistician on study team 9
Drug dose/side effects 10
Efficacy and Mechanism Evaluation Programme
Thank you
Any questions?
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