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
If the above criteria are met then take a look at the MRC guidance on how to design and conduct process evaluation
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
As stage 1, but also:
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.
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
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.
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.
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:
This article explains what is meant by each of the above points, covering such things as the need for a systematic review.
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.
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.
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