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Research for Patient Benefit Programme - Review of tier 3 funding

 

Contents

Background

RfPB competition 26, which launched in October 2014, saw the introduction of three funding tiers to provide guidance to applicants in terms of the amount of funding the programme would be willing to put towards certain types of research.

The overarching message was that RfPB panels would balance the probability of a proposal achieving patient benefit against the cost requested, meaning RfPB would be willing to put more funding towards a proposal which had a clear and close trajectory to patient benefit and less funding towards a proposal which was more distant to patient benefit. This was in the context of the programme’s existing funding limit of up to £350k over a duration of up to 36 months.

The aim of the funding tiers was to introduce different types of research into the programme and encourage more innovative and developmental research, which would typically have previously been out of the remit and scope of the programme. The introduction of tier 3 was also in response to feedback that it was challenging to secure funding, especially from research programmes, for developmental research and proposals that were further up the pathway to patient benefit.

Funding tiers

Although the programme had informally operated a funding limit of £250k for feasibility studies a more structured approach was detailed, including a whole new third tier.

  • Tier 1 (up to £350k) for research that has a clear and close trajectory to patient benefit, such as a definitive trial. 
  • Tier 2 (up to £250k) for research proposals which are feasibility studies. 
  • Tier 3 (up to £150k) for research which is on a pathway to patient benefit yet further from it

The programme provided some examples of the type of research which it expected would fall into tier 3:

  •  Observational studies using clinical databases, which might provide preliminary estimates of an effect size that would be useful in the design of a clinical trial. 
  • Observational studies to establish for example the practicality and acceptability of changes to clinical practice, or the best means to ensure and measure adherence, prior to a formal evaluation. 
  • Developing and refining interventions. 
  • Developing new scales or outcome measures. 
  • Exploratory studies, e.g. using qualitative methods that might provide insights into an intractable problem. 
  • Additional follow up of patients in a completed clinical trial. 
  • Post-market surveillance for unknown side effects of a drug (Phase IV trials). 
  • A systematic review, especially where the number of relevant studies is likely to be limited.

What has the programme funded under tier 3 to date?

The programme has received a wide range of applications to tier 3 and has funded a diverse range of projects to date.

Since the introduction of tier 3 in competition 26 to competition 29, a total of 21 projects have been funded under tier 3. The average tier 3 project is £143k and for a duration of 20 months. A total of £3m has been spent on tier 3 projects; these account for approximately 22% of all funded projects between competition 26 and 29.

The funded projects fall into the following research types:

  • 3 systematic reviews 
  • 7 developing and refining interventions 
  • 1 meta-analysis 
  • 1 realist synthesis 
  • 1 economic evaluation 
  • 6 secondary data analysis (including developing predictive models and needs assessments) 
  • 2 diagnostic accuracy studies

Although there is a wide range of research topics and designs funded under tier 3 the programme broadly categorises them into four types of research.

  1. Therapeutic – concerned with developing and evaluating interventions to improve patient benefit.
  2. Diagnostic – concerned with ensuring patients are appropriately classified to receive the above intervention
  3. Needs assessment – concerned with assessing the needs (usually of interventions) in a particular patient population
  4. Evidence synthesis.

What is the programme expecting from its tier 3 projects?

To date, none of the funded tier 3 studies have completed. Being on a pathway to patient benefit the programme anticipates that successful tier 3 studies will lead onto future research, for example feasibility or definitive trials of newly developed or refined interventions. However, the diverse nature of tier 3 projects means that the research will take various pathways to achieving patient benefit.

However, the four broad categories are likely to follow the pathways below:

  1. Therapeutic: once interventions and appropriate measures are finalised the research would progress to a trial, possibly via a feasibility study 
  2. Diagnostic – early ‘proof of concept’ evidence that a diagnostic marker might perform as well as or better than an existing one would lead to a diagnostic accuracy study in clinical practice or a diagnostic utility trial in which patients would be randomised to two or more diagnostic tests. 
  3. Needs assessment – may lead onto intervention development or service evaluation studies 
  4. Evidence synthesis: less a trajectory and more informs potential studies

List of funded tier 3 projects*

PB-PG-1215-20014 - Accuracy of high-speed video microscopy analysis to diagnose primary ciliary dyskinesia

PB-PG-0815-20030 -Pharmacological and non-pharmacological interventions to improve symptom control and quality of life in patients with interstitial lung disease: a systematic review

PB-PG-0215-36117 - A systematic review of physical activity for alcohol and substance use disorders: evidence synthesis with stakeholder engagement to formulate practical recommendations.

PB-PG-0815-20017 - Development and refinement of a STroke friendly Oral health Promoting (STOP) toolkit to improve oral self-care practices after discharge from hospital stroke services

PB-PG-0815-20019 - The development and feasibility of m-health technologies to improve hearing aid use and benefit in first-time hearing aid users

PB-PG-0815-20012 - Measuring and Improving the Health and Quality of Healthcare for Offenders on Community Sentences: Developing Recommendations for Commissioners and Practitioners

PB-PG-1014-35062 - Family based support to build capability and resilience in family carers of adults with learning disabilities and challenging behaviours: collaborative research.

PB-PG-0215-36149 - REFLECT - Recovery Following Intensive Care Treatment

PB-PG-0215-36009 - Inter-arm blood Pressure difference, cardiovascular events, cerebrovascular disease and mortality: an Individual Patient Data meta-analysis (INTERPRESS-IPD)

PB-PG-0815-20013 - Optimising hearing-Related Communication for care Home Residents with Dementia (ORCHARD): a realist synthesis

PB-PG-1215-20019 - Methotrexate versus Ciclosporin in the Treatment of Severe Atopic Eczema in Children: An economic evaluation

PB-PG-0215-36098 - Home or hospital for people with dementia and one or more other multimorbidities: what is the potential to reduce avoidable emergency admissions?

PB-PG-0815-20025 - Mapping Opportunities for earlier detection of Bipolar Disorder – Linking Big Data to Improve Patient Outcomes (MOBILISE)

PB-PG-0815-20009 - A mixed methods evaluation of online provision of oral contraceptives to measure: validity of self-reported biometric data; essential information transfer and user experience of self measurement and submission of biometric data.

PB-PG-0215-36027 - Female Aneurysm screening STudy - FAST

PB-PG-0815-20024 - Comorbidity as a predictor of referral to, and outcome from, surgery in primary care patients with newly diagnosed osteoarthritis in the hip: a population-based cohort study

PB-PG-1215-20017 - Excess risk and predictors of fracture/s following bariatric surgery for obese patients in the NHS: a real-world self-controlled case series and cohort study.

*Only 17 of 21 projects currently contra