Research Design Service: East Midlands

Latest News

Process evaluation – HTA tips from the funding committees

  Created on Thursday, 13 Aug 2020. Posted in Funding

Make sure the case of need and cost is described clearly, and the process evaluation activities are well integrated into the main study and not confused with other qualitative or recruitment optimisation activities

  • Needs to be well justified – usually process evaluation is seen in complex interventions to help explain why a treatment works or doesn’t work, for whom and in what context. But it’s not required unless it is justified which maybe more the case for new interventions or new care pathways
  • Take care how you describe it – too much detail will suggest that you are preparing for failure
  • Needs to be clearly differentiated from other qualitative elements of the study
  • Needs to be fit for purpose – you need to justify complexity and cost (remember HTA are aiming for rapid, simple and efficient trials)
  • Remember although implementation is normally considered within a process evaluation, planning and undertaking implementation work beyond the main trial findings is out of remit for HTA
  • Must be clearly integrated into the overall study – must clearly relate to key decisions and interpretation of the data

If the above criteria are met then take a look at the MRC guidance on how to design and conduct process evaluation 


Changes/updates to the SAF, with some specific changes relating to PPI

  Created on Tuesday, 30 Jun 2020. Posted in Public Involvement | Funding

Stage 1

  • Inclusion of public co-applicants, where appropriate, with a clear description of their role and the reasons why a public co-applicant is joining the team
  • PPI Lead - There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. This role should be an adequately costed and resourced research team member who is able to manage the PPI plans and related activities.
  • Justification of health/care need - Identify how will the public/patients see this as a need and as a potential improvement to their health and/or lives? 
  • Project Plan (Patient and Public Involvement):

o   show your plans for involving patients/service user, carers and the public at each appropriate stage of the research project lifecycle

o   outline how PPI has informed the development of the project so far, including how it has specifically shaped the research question and study design 

  • Dissemination plans: include details of how you will share with study participants the progress and findings of the study (PPI could inform this)

Stage 2

As stage 1, but also:

  • PPI Section:
  1. NEW PPI approach, management and support section to include:
  • why your approach to patient and public involvement is appropriate, including who will be involved and why
  • how you plan to manage and coordinate the patient and public involvement activities
  • how you will support and enable patients/service users, carers, the public and members of relevant communities to contribute to your research (e.g. access, payments, training).
  • outline plans for the capturing, evaluating and reporting the impact of patient and public involvement activities
  1. NEW Summary of PPI activities, including
  • a summary of the proposed PPI activities embedded throughout the research project lifecycle
  • clearly signpost to other sections of the Detailed Research Plan where the PPI is described further in relation to the relevant project stage
  • Costings - If voluntary, charity or community groups are supporting the research via activities such as facilitating contact with potential participants, hosting research activities or providing advice, an adequate budget must be included to compensate for their time and resources.


UK Government commits £12million to research into preventable diseases

  Created on Tuesday, 17 Mar 2020. Posted in Funding

The UK Government has committed an extra £12million to the National Institute for Health Research in 2020/21 for research into preventable diseases. Heart disease, diabetes, chronic respiratory diseases and cancer are all linked to preventable causes and contribute to slowing improvements in life expectancy, and regional and socio-economic inequalities in health outcomes. This new investment will be directed particularly towards Local Authorities, helping them grow and support their research capabilities so they can work further to solve a range of major preventable health challenges. The aim is that this will support the Government’s work to increase healthy life expectancy by 5 years by 2035, while narrowing the gap between the experience of the richest and poorest.

New funding opportunity seeks to build clinical trials experience for researchers

  Created on Tuesday, 10 Mar 2020. Posted in Funding

Two NIHR funding programmes are joining forces as part of a pilot to provide health researchers the opportunity to undertake a career development award alongside leading an NIHR programme funded clinical study.

For the first time, the Efficacy and Mechanism Evaluation (EME) programme is inviting applications for clinical studies to be led by a chief investigator who is also applying for an NIHR Advanced Fellowship Award. Researchers from across all areas of health are encouraged to apply. The study proposal should evaluate an intervention or medical test with the potential to maintain health, treat disease or improve recovery.

The EME programme is a partnership between the Medical Research Council (MRC) and the NIHR, and both are keen to explore new ways to support the development of capacity and expertise in conducting clinical trials.

Applications to the EME programme are now being accepted and the deadline for these is 16 April 2020. Applications to round four of the Advanced Fellowship scheme will launch at the beginning of April with a deadline for submissions in early June.
Find out more here

HTA - spending wisely when managing delays

  Created on Friday, 17 Jan 2020. Posted in Funding

The HTA vlog this month talks about dealing with delays in projects and how to manage funds wisely.

Trials sometimes face delays in start-up due to negotiating contracts, study drugs and placebos manufacture, data linkage agreements or in completing the feasibility stages of the project. These delays have a knock on effect for the completion date of trials that require a contract variation for extra time and money. Requests for extra funds however are not easily granted as they are viewed in competition with new funding proposals. Research teams need to make it as attractive as possible to funders to grant extensions. One way to do that is to show that you've been a good guardian of public funds and during the delay period you've built up an underspend which can be off set against the contract variation to complete the project.

Measures to build up an underspend could be suspending payments to those not working on the project during the delay period or redeploying trial staff until they are needed. It's always good to keep the sponsors and HTA secretariat informed about delays and your plans to mitigate costs. Although underspend needs to be returned on an annual basis to comply with the government's annual reconciliation rules the underspend returns will not affect the overall funding envelope agreed with the programme and can be used in the extension period.

HTA update: Multi-morbidity or rather multiple long-term conditions!

  Created on Tuesday, 12 Nov 2019. Posted in Funding

This month's update from HTA addresses who should be included in clinical trials in relation to multi-morbidity.

Multiple long-term conditions are not easy to research as the understanding of disease clustering whether genetic, early risk factors or attributes of age, poverty and geography is still at an early stage, but what we can do is be more vigilant as to who we include in clinical trials. Unless there are very good reasons to exclude people then researchers should strive to include those who are often in the past been excluded from trails such as those with multiple long-term conditions.

It’s recognised that being more inclusive might result in slightly larger sample sizes and data from efficacy studies might not be the best on which to base planned sample size calculations but we need to try and base our clinical trial plans on as much real world NHS data as possible.

Also including lots of different people in clinical trials risks diluting the ability to detect changes, as some groups are less likely to benefit from the intervention or they may have much poorer follow up data, but we must do what we can to achieve a reasonable balance.

HTA will be looking carefully at exclusion criteria in applications. Study populations should be a sensible balance between feasibility, cost and the ability to generalise to the wider NHS population.

Guidance on whether an intervention is ready for HTA evaluation

  Created on Friday, 01 Nov 2019. Posted in Funding

Given that national pragmatic HTA trials typically cost over £1m of public funds, the HTA programme needs to be convinced that an intervention is ready for HTA evaluation.

The HTA have written a document outlining issues that may determine this judgement in relation to intervention studies.

Generally, an intervention is ready for HTA evaluation if:

  • There is a reasonable chance that it will be effective
  • It has already been tested in a typical NHS or social care setting
  • There is a reasonable chance it will be used across the NHS if shown to be effective

This article explains what is meant by each of the above points, covering such things as the need for a systematic review.

HTA update: no more feasibility studies funded in researcher-led scheme!

  Created on Wednesday, 03 Jul 2019. Posted in Funding

HTA has decided to no longer fund feasibility projects in its researcher led workstream. This is due to the fact that they are often costed at 4 times the equivalent of a feasibility project going to RfPB, they're over engineered and its difficult to judge value for money as the size and effect of a main trial remain obscure.

Instead HTA would like to see full trials with robust internal pilots to evaluate key feasibility outcomes and will fund such projects through staged payments.

HTA will continue to fund feasibility studies though it's commissioned workstream where the work is deemed to be absolutely essential and isn't likely to be funded selsewhere.

Lastly if a clinical trial is submitted to HTA based on a feasibility study you need to ensure that along side feasibility there also needs to be a convincing efficacy signal otherwise its unlikely to be funded.


£25 million funding awarded to leading disease prevention projects

  Created on Tuesday, 14 May 2019. Posted in Funding

A partnership of twelve funders including charities, UK Research and Innovation (UKRI) councils and the UK health and social care departments have established the UK Prevention Research Partnership aiming to develop, test and refine new, practical and cost-effective approaches to preventing non-communicable diseases.

The £25 million has been earmarked for eight projects tackling the bigger picture factors behind the prevention of non-communicable diseases (NCDs) - illnesses that can’t be passed from person to person - such as heart disease, obesity, poor mental health, cancer and diabetes. NCDs make up the vast majority of illnesses in the UK, accounting for an estimated 89 per cent of all deaths. These projects aim to deliver real changes that reduce the burden of these diseases on our health and social care systems and enable people to live longer, healthier lives. 

EME proof of concept

  Created on Thursday, 11 Apr 2019. Posted in Funding | Guidance

All applications to EME must cite some evidence that the intervention could work, i.e. that there is “proof of concept”. How much prior evidence of potential efficacy is needed will vary with the size of the translational step, the scale of the proposed study and the nature of the intervention. This document looks a examples of proof of concept that are accepted by the EME Funding Committees