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IGNITE your.... medical funding opportunities Presenter - Dr Lisa Douet, Senior Research Fellow, and Ellie Monks, EME Programme Manager will present about “Research Funding: The Efficacy and Mechanism Evaluation Programme” The EME Programme funds clinical efficacy studies. The studies it supports usually test if an intervention works as expected, in a well-defined population or group of patients. The Programmealso also provides an opportunity to use clinical studies to understand disease or treatment mechanisms, which may in turn lead to improvements in health and patient care.
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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?