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