Research Design Service: East Midlands

Latest News

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. 

The list of current award recipiants and the next call for proposals will be launched in autumn 2019.


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


NIHR research applications - Cost variance between stage 1 and stage 2

  Created on Tuesday, 09 Apr 2019. Posted in Costing | Funding

There has been a question about the amount by which applications may vary in cost between Stage 1 and Stage 2 and a perception that costs should not vary by more than 10%. The official position is now that “It is accepted that a variance in costs is likely to occur between Stage 1 and Stage 2, but costs at each stage should represent value for money. Advisory committees may provide project specific costing guidance/feedback following stage 1.”


i4i Challenge - real-world implementation

  Created on Thursday, 04 Apr 2019. Posted in Funding

Every year innovators in England develop countless promising medical technologies, many of which are funded by the NIHR. But too many don’t make it all the way into the NHS and across the finish line of patient benefit.

In order to be of interest to the NHS, a product must address an existing clinical problem. It should be measured against the right comparators, and demonstrate either better patient outcomes, or cost savings, or both. In addition, its implementation needs to be sustainable; furthermore, there is a need to identify the clinical pathway that will be disrupted with its use, and the consequences of that disruption.

These questions are particularly difficult for SMEs to answer, as this requires novel trial approaches and a multidisciplinary effort, involving not only technology developers, but also clinicians, methodologists, health economists, implementation scientists, amongst others. These interventions can be expensive, and financial and time constraints sometimes limit their scope.

To help overcome this hurdle i4i is dedictaing its i4i Challenge Awards to real world implementation of mearket ready medtechinnovations.


NIHR launches £56 million new funding competition for public health research

  Created on Wednesday, 27 Mar 2019. Posted in Funding

The NIHR has launched a new funding competition to allocate up to £56 million of funding over 5 years to public health research. The competition will award funding from the Department of Health and Social Care to 14 NIHR Health Protection Research Units (HPRUs) - partnerships between academic institutions and Public Health England (PHE). These new units will act as centres of excellence in multidisciplinary health protection research in England.


New NIHR funding and awards database

  Created on Wednesday, 20 Mar 2019. Posted in News Items | Funding

The NIHR have launched a new funding and awards database covering all of their funding streams, listing current and past projects.

Information on each award covers plain English summary and abstract, as well as the funding amount, investigators, start and end date, funding stream, research type and contracting organisation.