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Commissioned and Researcher-led Workstreams:

  1. Commissioned workstreams
  2. Researcher-led workstreams

Ways of Working:

  1. Full and appropriate funding
  2. Needs-led
  3. Science-added

Research Methods:

  1. Feasibility and Pilot studies
        - Feasibility studies
        - Pilot studies
        - Which programme should I apply to?
  2. Diagnostic tests
        - Which programme should I apply to?

Other terms:

  1. Glossary for public and patient contributors

 


Commissioned and Researcher-led Workstreams

Commissioned workstreams

Commissioned workstreams start with the information needs of decision makers typically, but not exclusively, within the NHS. These are refined and prioritised by people with expertise in the field, and commissioning briefs are advertised. Applications are then assessed for compliance with the commissioning brief, scientific quality, feasibility and value for money.

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Researcher-led workstreams

Researcher-led workstreams are open calls for researchers to apply for funding for their own topics and questions. These applications are prioritised in terms of NHS or other information need in a process similar to that in the commissioned workstreams. Applications are then assessed for scientific quality, feasibility and value for money.

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Ways of Working

Full and appropriate funding

Full and appropriate funding is provided because we place no upper limit on the amount of funding granted for a project. Subject to availability of funds, if the question is important enough and the science requires it, we will fund it. For University based projects we will fund up to 80% of the Full Economic Cost (FEC) of the research, and 100% of the direct costs for NHS Trust based projects. Other organisations are also welcome to apply to our programmes and should discuss the basis of costing with us.

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Needs-led

We are needs-led because we assess what the important questions are and in what priority they should be answered. We actively ensure that our programmes meet the needs of decision makers. We ensure we are needs-led throughout the funding pipeline by actively assessing need and priority for all funding streams.

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Science-added

We are science-added because we ask whether the proposal meets the scientific quality we insist on, and how can we support the delivery and improvement of quality. We actively apply scientific knowledge, expertise and methods to support the scientific quality of proposals and funded research. We communicate closely with the research community, and provide significant post award support and monitoring.

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Research Methods

Feasibility and Pilot studies

This is a definition that has been agreed by the EME, PHR, HS&DR, HTA and RfPB Programmes.

We expect that when pilot or feasibility studies are proposed by applicants, or specified in commissioning briefs, a clear route of progression criteria to the substantive study will be described. Listing clear progression criteria will apply whether the brief or proposal describes just the preliminary study or both together. Whether preliminary and main studies are funded together or separately may be decided on practical grounds

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Feasibility studies
Feasibility Studies are pieces of research done before a main study in order to answer the question “Can this study be done?”. They are used to estimate important parameters that are needed to design the main study. For instance:

  • standard deviation of the outcome measure, which is needed in some cases to estimate sample size;
  • willingness of participants to be randomised;
  • willingness of clinicians to recruit participants;
  • number of eligible patients; carers or other appropriate participants;
  • characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure;
  • follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc.
  • availability of data needed or the usefulness and limitations of a particular database; and
  • time needed to collect and analyse data.

Feasibility studies for randomised controlled trials may not themselves be randomised. Crucially, feasibility studies do not evaluate the outcome of interest; that is left to the main study.

If a feasibility study is a small randomised controlled trial, it need not have a primary outcome and the usual sort of power calculation is not normally undertaken. Instead the sample size should be adequate to estimate the critical parameters (e.g. recruitment rate) to the necessary degree of precision.

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Pilot studies

Pilot studies are a version of the main study that is run in miniature to test whether the components of the main study can all work together. It is focused on the processes of the main study, for example to ensure recruitment, randomisation, treatment, and follow-up assessments all run smoothly. It will therefore resemble the main study in many respects, including an assessment of the primary outcome. In some cases this will be the first phase of the substantive study and data from the pilot phase may contribute to the final analysis; this can be referred to as an internal pilot. Or at the end of the pilot study the data may be analysed and set aside, a so-called external pilot.

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Feasibility and Pilot studies: Which programme should I apply to?

There are a number of NIHR programmes which will fund feasibility and pilot studies.  There are no strict rules about which programme funds which feasibility or pilot study and it is for applicants to choose the most appropriate in the context of the guidance on applicability provided by each programme. For RfPB click here and for the five NETS programmes click here. Nevertheless, in choosing you might like to consider the following:

  1. Is the programme appropriate in terms of geography and grant size (RfPB funding, for example, can only be accessed through NHS bodies and other providers of NHS services in England and has a maximum grant size of £350,000)?
  2. Can a robust case be made for the plausibility of the intervention and clinical importance of any subsequent full trial?  If there is good proof of concept and/or efficacy data available and there is a clear plan to explore the intervention further in a large clinical trial, then HTA or EME might be considered the latter in particular if there are substantial mechanistic elements and laboratory support involved in the project.  On the other hand, if the feasibility or pilot study is for a potential trial which might be viewed as more speculative, with no clear plan for a large trial in the very near future, or in which there seems a high risk that the pilot/feasibility study is likely to demonstrate that a full trial is not possible, then the smaller sums that RfPB provide might be seen as more appropriate. 

Note that feasibility and pilot studies should be distinguished from Phase II trials, in which some sort of evidence for efficacy, often in a surrogate marker, is sought prior to embarking on a full Phase III trial: EME might be the most appropriate funding stream for these if there is strong scientific interest in the question, and RfPB if there is a clear potential trajectory into patient benefit. 

The Public Health Research programme also funds feasibility and pilot studies within its remit of evaluating public health interventions delivered outside the NHS.

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Diagnostic tests

This is a definition that has been agreed by the EME, PHR, HTA, RfPB and i4i Programmes.

A diagnostic test is an indicator or predictor of an illness state.  As such the term needs to be interpreted broadly as it includes tests used to help make a diagnosis or screen for a disease, tests to stage disease, to monitor treatment, and to estimate prognosis.

There a number of types of diagnostic study which will be considered by NIHR:

  • The first of these is the development of a new test or instrument and/or the broad assessment of its reliability and validity.  These might range from questionnaires that identify mental states to molecular assays.  Test development and/or testing for psychometric properties or analytic validity, as it is called in the ACCE framework, are only supported to the extent that the test technology is well-developed and forms part of a clear pathway into further research which directly promotes patient benefit. 
  • Diagnostic accuracy studies examine the clinical validity of a test, ie whether the changes in the measure reflect changes in disease state or risk, and usually assess a new test against a gold-standard or reference one.  Such studies are likely to report sensitivity and specificity, positive and negative predictive values and Receiver Operating Characteristic (ROC) curve in a defined population
  • Diagnostic utility studies examine the value of a diagnostic test in improving patient outcomes, and are often designed as trials and powered on relevant clinical endpoints. Economic outcomes may also be important.

Diagnostic tests: Which programme should I apply to?

  • Application can be made to the i4i Programme which funds innovative technologies that offer significant patient benefit.  Otherwise for test development and assessment of test properties, the RfPB Programme is an appropriate funding source if the trajectory into patient benefit is likely to be short. 
  • Stand-alone studies of diagnostic accuracy are most likely to be submitted to RfPB.
  • Studies of diagnostic utility (even if they also contain components looking at diagnostic accuracy) should be submitted to HTA .
  • Diagnostic utility studies should be submitted to EME if they included studies of mechanisms or promote understanding of pathophysiology.

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The NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), based at the University of Southampton, manages evaluation research programmes and activities for the NIHR.

 

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