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20/142 Prehabilitation: Living with and beyond cancer guidance notes and supporting information

 

Contents

The following NIHR-managed research programmes are participating in the Rehabilitation: Living with and beyond cancer call. The information included is intended to give an overview of the scope and remit of each programme and link through to the programme specific guidance notes and supporting information. Research proposals must be within the remit of at least one participating NIHR Programme. Applications which span the remit of one or more of the participating NIHR Programmes are welcomed.

Efficacy and Mechanism Evaluation (EME)

Jointly funded by NIHR and the Medical Research Council (MRC), the EME Programme primarily supports clinical trials, and other robustly designed studies that test the efficacy of interventions. The interventions should have the potential to improve patient care or benefit the public. The programme will only support studies where there is sufficient evidence that the intervention might work in man, i.e. that there is ‘proof of concept’.

Innovative study designs involving stratification, the use of routinely collected digital data or novel methodologies are strongly encouraged.

Where appropriate, the programme encourages hypothesis-testing mechanistic studies integrated within the main efficacy study.  These studies could explore the mechanisms of action of the intervention, the causes of differing responses, or promote an understanding of any potential adverse effects and how these could be reduced; they could also contribute to understanding of the disease.

The programme will accept applications for studies that use clinical or well-validated surrogate outcomes. It will also consider studies that validate potential surrogate outcomes against a primary clinical outcome, within the main clinical trial.

EME Programme guidance notes and supporting information

The EME Programme will support:

  •  Research to determine proof of clinical efficacy, size of effect, and long-term safety in a well-defined population.
  • The evaluation of a broad range of interventions that have the potential to maintain health, treat disease or improve recovery.
  • Hypothesis-testing research based on an efficacy study, to explore the mechanisms of action of interventions, causes of differing responses or disease mechanisms. These studies use data or samples obtained and stored from both treatment and control groups of a clinical study, to arrive at conclusions that would not arise from a simple cohort study.
  • Novel or repurposed interventions and technologies

The EME Programme will not support:

  • Large effectiveness studies that test the impact of the introduction of an intervention in the wider NHS (our HTA Programme may be more suitable).
  • Hypothesis-generating studies based on sample or data collections from patient cohorts.
  • Confirmatory studies, equivalence studies, 'confidence in effect' studies or studies of incremental modifications to existing interventions.
  • Discovery of new bio-markers
  • Research into areas where the health need is primarily outside the UK.
  • Any research involving animals or animal tissues (see our animal testing page for more information).

Proposals may include two stages with progression to the main clinical evaluation dependent on the outcome of the previous stage, measured against predefined criteria. The main clinical evaluation must start within 18 months of the project start date and should account for more than 75% of the total project cost.

Staged studies will require predefined stop/go decision points, with measurable criteria to enable assessment of the successful completion of the stage. Studies may on occasion, be reviewed by the EME Committee at the end of each stage before progression to the next stage.

Health Services and Delivery Research (HS&DR)

The HS&DR Programme funds research to produce evidence to impact on the quality, accessibility and organisation of health and social care services. Robust mixed methods studies, or evidence syntheses, are invited with a focus on the organisation and delivery of services, costs, quality, and patient, service user or carer experience. Proposals should be multicentre and aim to produce generalisable findings. Research may evaluate the impact on health, health service and social care outcomes.

HS&DR Programme guidance notes and supporting information

The HS&DR Programme will support:

  • research into any aspect of health and social care service quality, accessibility and effectiveness, as long as its importance to the NHS and social care can be clearly demonstrate
  • any methodology as long as it is appropriate, proportionate and likely to answer the research questions – which must relate to health service and social care issues
  • trials, pilot and feasibility studies on relevant topics, with the involvement of a Clinical Trials Unit if required. In the case of a trial, adequate preparatory work must be completed in order to justify need and feasibility

The HS&DR Programme will not support:

  • research for which there is not a strong and well demonstrated case for importance to the NHS/ social care
  • research in a single site which is not likely to be generally applicable to other settings or patient groups
  • basic scientific or epidemiological research on the causes of disease
  • the testing of new health technologies or diagnostic techniques – these may fall within the remit of the HTA Programme 
  • the establishment of a database, as an end in itself. All studies must include specific research questions, and all data collection must directly contribute to answering these questions
  • the setting-up or maintenance of research units
  • proposals which are solely or mainly service developments, audits or needs assessments
  • PhD studentships

Health Technology Assessment (HTA)

The HTA Programme supports research that is immediately useful to patients, clinical practice, and policy or decision makers. Research can evaluate any intervention used in the treatment, prevention or diagnosis of disease, provided the study outcomes lead to findings that have the potential to be of direct benefit to NHS patients. The intervention needs to be ready for HTA evaluation, in terms of having a clear signal of efficacy and potential to be delivered across the NHS. The inclusion of social and occupational outcomes in addition to health outcomes is encouraged.

The purpose of an HTA study is to establish the clinical and cost-effectiveness for the NHS in comparison with the current best alternative(s). A study may also investigate uncertainty around a technology’s place in the existing care pathway.

“Technologies” in this context mean any method used to promote health; prevent and treat disease; and improve rehabilitation or long-term care. They are not confined to new drugs and include any intervention used in the treatment, prevention or diagnosis of disease.

HTA Programme guidance notes and supporting information.

The HTA Programme will support:

  • systematic reviews
  • economic models
  • meta-analyses
  • mixed-treatment comparisons
  • expected Value of Information studies
  • randomised controlled trials (unblinded, single-blinded, double-blinded, triple-blinded)
  • non-randomised trials
  • single-centre studies where a strong case has been made for this type of design and there is assurance the results will be generalizable to the wider NHS
  • cohort studies (retrospective or prospective)
  • adaptive designs
  • modelling studies
  • international studies

The HTA Programme will not support:

  • phase 2 trials (our EME Programme may be more suitable)
  • research on new equipment
  • PhD research
  • proposals currently pending with another research funder
  • The HTA will not fund standalone pilot and feasibility studies unless requested within a commissioning brief
  • PhD studentships

Public Health Research (PHR) 

The programme funds research to generate evidence to inform the delivery of non-NHS interventions, specifically, we provide new knowledge on the benefits, costs, acceptability and wider impacts of non-NHS interventions intended to improve the health of the public and reduce inequalities in health.

PHR has a particular concern with generating evidence to underpin scalable interventions that operate at a population or whole system level and/or across the life-course.

PHR Programme guidance notes and supporting information.

The PHR Programme will support;

  • applications focused on intervention development where an intervention already exists and for which there is an evidence base, but it requires adaptation to situations such as a new context (e.g. a change in setting or target behaviour or client group) or amalgamation of separate, defined interventions so that they complement each other.
  • Where a compelling case is made, we will also fund work to establish feasibility and to pilot a definitive intervention. However, any work related to optimising an existing intervention prior to evaluation, where research has shown that the intervention performs sub-optimally and there are specific remediable aspects of the intervention such as the delivery method or the timing of elements, must not exceed 6-months in duration.

The PHR Programme will not support;

  • The creation of new interventions, or processes, where active components of existing interventions are recombined to create a new intervention whether or not driven by a logic model or underlying theory.
  • The design and development of new websites, apps, text messages or other software designed as all or part of creating a new intervention. Websites or other supporting material with the aim of publicising the study or supporting study recruitment, for example, which is only required to carry out the research study, would be supported within the general rules of the programme as would material associated with the optimisation of an existing intervention prior to evaluation.