Top Tips - HTA
Research focus:
- Funds research into the clinical effectiveness, cost-effectiveness, and impact of healthcare treatments, tests, and other interventions
Scope:
- Funds diverse studies, including existing practices
- Operates across the UK; proposals should address broader national interests.
- Big grant – the average award is approximately £1.5 million, focused on significant studies.
Funding panels:
- Researcher-led calls: Researchers propose studies to address identified healthcare problems.
- Commissioned calls: Target specific research questions identified by the HTA.
- Rolling calls: Related to priorities from the James Lind Alliance and research needs from NICE.
Intervention readiness for HTA evaluation:
- There is a reasonable chance that the intervention 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
Effectiveness vs. Efficacy:
- Applications should focus on effectiveness rather than efficacy in language and presentation.
Applicant team requirements:
- Diverse and justified expertise is essential (with enough time to support the study); avoid teams that lack relevant experience.
- Involve and work with a Clinical Trials Unit (CTU)
- Consider having co-CI if necessary
- Clarify differences between co-applicants and collaborators
Patient and Public Involvement (PPI):
- Robust PPI is vital; it should be integrated throughout the study, not just as an afterthought.
- Include involvement and contribution to date as well as plans for future contributions
- Needs to be appropriately resourced
- Both lived experiences and professional representatives can be included in proposals though lived experience is more important.
Feasibility and internal pilots:
- Include details on the practical issues, who will do what, if the timings are realistic, and evidence for the recruitment estimates
- Proposals must include internal pilots and milestones to assess progress.
Costings:
- Good value (not the same as cheap) means justifying the importance of the work and the necessity of all elements included
- Cutting costs excessively may raise concerns about feasibility.
- Avoid extraneous data collection that does not directly contribute to answering the research question.
- Costs for research inclusion can be added in order to gain a diverse research sample
Size of study:
- Resource justification should be clear, balanced, and well-supported with assumptions.
- Linked to the study design and planned analysis, and able to answer the research question to ensure confidence in changing practice.
- Should address generalisability across the NHS or social care
- Sample size calculations are required for most studies with full justification of parameters either from feasibility work or literature.
Outcomes:
- Outcomes should be relevant to both patients and clinicians
- The primary outcome should be health- or social-care-related.
- Utilise validated measures and ensure outcomes align with the original hypothesis.
- Consider the burden of data collection on participants.
Diversity and Inclusion:
- HTA emphasises thoughtful diversity and inclusion in studies, addressing specific questions about the applicability of trial results to different populations.
- Address questions like the following:
- Who are the results going to apply to?
- Are they likely to respond to the intervention in different ways?
- Will the intervention make it harder for them to respond?
- Will the trial design make it harder for them to take part or remain in the trial?
Novel trial designs:
- The HTA is open to funding novel trial designs, provided they are justified by the study question.
- Clearly explain and validate unfamiliar designs to gain panel confidence.
Studies within a trial:
- Opportunities exist for additional funding for studies within trials, aimed at reducing redundancy and increasing efficiency.
Proposal quality:
- Ensure coherence and clarity throughout the proposal, avoiding generic sections and jargon.
- Provide a good theoretical justification as to why the intervention is a good fit for the group/disease.
- Get your work peer-reviewed to check for clarity and consistency.
- Peer review happens before panel evaluation; proposals may be rejected at this stage if they don't fit.
Stages of review:
- Stage 1 focuses on summarising all aspects of the study; balanced detail is crucial.
- In Stage 2, responses to reviewer comments provide an opportunity to clarify and strengthen the proposal.
- Expect potential changes to funding agreements based on panel feedback.
Common submission outcomes:
- Most applications are rejected at Stage 1; key issues may include the importance of the question, major design flaws, or accumulation of many things.
- At Stage 2, outcomes are typically to reject or fund with changes; ongoing discussions about modifications are common.
- Get in touch with the Research Support Service (RSS) to get advice on addressing or responding to the funding panel’s feedback comments.
What makes a good Stage 1?
- Comprehensive summary: Provide a clear overview of all aspects of the study.
- Importance of the question: Clearly demonstrate the significance of the research question and the ability to answer it.
- Alignment with HTA remit: Ensure the proposal is relevant and fits within the HTA's focus areas.
- Cost considerations: Even if only summary figures are provided, show that practical needs have been carefully considered.
- Patient and Public Involvement (PPI): Recognise the importance of PPI and address how it is integrated into the study.
Responding to reviews
Opportunities:
- Use the response as a chance to provide greater clarity on your proposal.
- Indicate any new developments or insights that have emerged since submission.
Avoid:
- Being argumentative: Do not dispute reviewer comments aggressively, even if you disagree.
- Agreeing to all changes: Resist the temptation to simply accept every suggested modification without careful consideration.
- Fundamental changes: Avoid altering your core research question in response to feedback.
- Unfunded additions: Don’t include new elements in your proposal that exceed your budget or resources.
What makes a good Stage 2?
- Detailed description: Provide a thorough overview of all aspects of the study.
- Scientific capability: Demonstrate that you can answer the research question effectively, highlighting the strengths of your team.
- Justification of costs and resources: Clearly justify the budget and resources required for the study.
- Importance of PPI: Emphasize the role of Patient and Public Involvement as essential to the study.
- Risk management: Identify potential risks to the study and outline strategies for mitigating them.
- Response to Stage 1 feedback: Show how you have addressed and incorporated feedback received during Stage 1.
- Thoughtful engagement: Provide a reflective and considered response to all major points raised by reviewers.
Author: Doyo Enki Created: March 2021 Last Updated: November 2024