Introduction
The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Call scope
The HTA Programme is inviting applications for studies using innovative data-enabled clinical trial designs to answer important research questions in health and social care.
Through this call, the HTA programme is hoping to attract ambitious data-enabled trial proposals (or “e-trials”) that can use routine data sources for key trial processes, such as patient identification, intervention delivery and for collecting outcomes in an efficient way. Proposed interventions need to be mature enough to be tested on a national scale. Applications should include an internal pilot to ensure that the study can accurately capture the data required to complete the trial.
Applicants need to demonstrate first and foremost that the proposed work addresses an identified and important health-related research question which, if answered, will make a difference to practice and health while supporting evidence-informed decision-making. In their proposal applicants will need to demonstrate to the programme that simply exploring how routine data can be used is not the primary purpose of a proposed piece of work. Additionally, it is noted that this is not an opportunity to build infrastructure to support future studies.
The programme is particularly interested in ambitious studies that use data-enabled approaches at scale. Applicants should note the HTA programme is also interested in proposals that include participants or populations who would not normally be engaged with research due to their location or socio-demographic characteristics; the programme wishes to contribute to addressing health inequalities through engagement in research and bring research to areas of the country of most patient or population need. However, the programme is looking for scale first and foremost.
Despite the potential challenges of doing this sort of research, the programme will be looking to ensure that research proposals are engineered as simply as possible, and researchers are asked to demonstrate this in their application. The programme wishes to emphasise that proposals need to be efficient in order to be impactful – by which we mean less costly, as well as (usually) faster and larger than equivalent studies that take traditional approaches. Applicants will therefore need to explain how their proposed study will deliver robust answers using streamlined approaches.
Applicants will have to demonstrate an intention to ensure longevity of data collection methods, and its adaptability beyond the immediate context of the trial or study, where relevant. The programme is also interested in proposals which build on existing algorithms and data linkage solutions. Applicants need to explain what the risks might be to delivering the study as proposed, and how these risks might be mitigated – this could include issues of timeliness of data access. The programme will want to understand how applicants will work with regulators and legislative frameworks, such as GDPR.
Applicants are reminded that the expertise required to deliver the type of trial or study for this call is likely to be different, at least in part, from the more usual project and trial management approach. The make-up and expertise of the team will need to be credible and proportionate from the outset of the application process. The team will need to demonstrate that they have knowledge and experience in handling the data that will be used in the study.
Applicants are encouraged to consider the inclusion of a methodological sub-study within their proposed research, which could significantly improve methodology for future research as well as this study. Find out more about the benefit of SWATS/SWARs and how to include one in your application.
Given the scope of this call, we expect to receive applications from coordinated multidisciplinary teams of investigators spanning both health and non-health specialties/disciplines, bringing together all the necessary skills and expertise required to deliver the research proposed.
References
Sydes MR, Barbachano Y, Bowman L The Data Enabled Trials Group Workshop Group members, et al: Realising the full potential of data-enabled trials in the UK: a call for action
Making an application
If you would like to apply for this opportunity, you can begin your application via the funding opportunity page.
Your application must be submitted online no later than 1pm on the 27 November 2024. Applications will be considered by the HTA Funding Committee at its meeting in January 2025.
Guidance notes and supporting information for HTA Programme applications are available.
Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2025.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).
For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.
Should you have any queries please email: htacommissioning@nihr.ac.uk