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Ignite your medical funding opportunties eme


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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.

Published in: Business, Health & Medicine
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Ignite your medical funding opportunties eme

  1. 1. Research Funding: a view from the Efficacy and Mechanism Evaluation (EME) Programme Dr Lisa Douet, Senior Research Fellow and Ellie Monks, Programme Manager 11/12/2013
  2. 2. 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
  3. 3. Efficacy and Mechanism Evaluation Programme Managed Translational Pathway
  4. 4. Efficacy and Mechanism Evaluation Programme Translating science into better health • 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
  5. 5. Efficacy and Mechanism Evaluation Programme Overview of EME • 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.
  6. 6. Efficacy and Mechanism Evaluation Programme Mechanisms of working: researcher-led work stream • Standard mode (two stage application) On going call with 3 closing dates a year Preliminary application submission deadline to funding decision around 8 months • Fast track (single stage application) Reduces time to funding decision by ~ 3 months Allowed in exceptional circumstances where reducing the timescale will: • provide significant benefit, • allow exploitation of a narrow window of opportunity
  7. 7. Efficacy and Mechanism Evaluation Programme Mechanisms of working: commissioned work stream • 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.
  8. 8. Efficacy and Mechanism Evaluation Programme Current EME commissioned calls • • 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
  9. 9. Efficacy and Mechanism Evaluation Programme Future EME commissioned calls • 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
  10. 10. Efficacy and Mechanism Evaluation Programme Funded studies • 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
  11. 11. Efficacy and Mechanism Evaluation Programme Examples of Funded studies Researcher-led 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 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
  12. 12. Efficacy and Mechanism Evaluation Programme Top 10 reasons for rejection Reason for rejection Trial design issues Poorly written application/ case for trial needed to be stronger Sample size/power calculation/stats issues Justification of end point measurements Justification of costs of required Lack preliminary data Recruitment issues (including drop rates and recruitment targets) Issues relating to the selection of patients/population chosen Lack of inclusion of CTU/statistician on study team Drug dose/side effects Rank Order 1 2 3 4 5 6 7 8 9 10
  13. 13. Efficacy and Mechanism Evaluation Programme Thank you Any questions?