1. How to apply successfully to the NIHR HTA Board?
Prof Martin Dennis

2. Credentials Chief investigator Co-investigator Reviewer
HTA funded trials
FOOD trials
CLOTS trial 3
Co-investigator
HTA funded syntheses of evidence
Reviewer
Occasional board member

3. Process

4. The main output

5. Main points Important question to NHS & patients Systematic review
Burden
Supported by peers
Potential for improvement in 5 years
Systematic review
Robust study design
Feasibility – demonstrated in pilot/start-up
Value for money and < £2.5 million
Well written and clear application
Comprehensive trial team and facilities with track record

6. Characteristics of HTA research
Evaluates:
Effectiveness of a medical intervention in a real life NHS setting.
Types of research:
Primary (clinical research), secondary (evidence synthesis, e.g. a systematic review or meta analysis), usually pragmatic research with routine care.
Stages of research:
The main focus of HTA research is long-term effectiveness and the impact on patients’ quality of life as well as cost-effectiveness. These studies would evaluate effectiveness in a real-world NHS setting.

7. Characteristics of HTA research
Design:
Often a pragmatic RCT although other study designs may be used for instance in the evaluation of diagnostic tests.
Participant eligibility criteria:
Wide & representative of the UK population and reflects the mix of patients likely to be seen in normal clinical practice.
No. of participants & centres:
Generally large – adequate to assess minimally important differences from a patient perspective;
usually multicentre generating results that are generalisable to the NHS.
Technology* Fully defined and developed technology.

8. Characteristics of HTA research
Comparator:
The best active alternative or usual care.
Placebos may be used in conjunction with best treatment to blind trial participants.
Outcomes:
Clinically important outcomes that matter to patients and that measure health gain.
Follow up:
Sufficient to ensure that a wider range of effects are identified other than those which are evident immediately after treatment.

9. Characteristics of HTA research
Health economic component included?
Usually cost-utility or cost-effectiveness.
Can a mechanistic evaluation be included as part of the main study?
Not usually, it would only be a secondary consideration to assessing cost-effectiveness.
Diagnostic evaluations?
Unlikely to support evaluations which seek to determine the normal range of values for a diagnostic test through observational studies in healthy people.
Likely to support the evaluation of cost-effectiveness in routine clinical practice.

10. Choosing a Research Question

11. HTA Remit
The HTA programme supports research that is immediately useful to clinical practice and policy/decision makers.
HTA research is undertaken when there is evidence to show the technology is efficacious but there is uncertainty around its clinical and cost effectiveness in a real life NHS setting in comparison to the current best alternative(s).

12. The HTA programme commissions research in four different ways:
through the commissioned funding stream which advertises calls for research proposals that address specific topics
by advertising special calls for research proposals that address themed areas
by funding HTA clinical trials and evaluation studies that are proposed directly by researchers
Technology assessment research (TAR)
for NICE guidelines etc

13. Look at the website
Are the HTA wanting a question answered which you would like to answer and
in which you have expertise and a track record?

14. Get backing for your research question
Get your friends to write to HTA to say that the issue you want to address is really really important!!
Get patients. Carers etc etc to write
Address questions highlighted in guidelines and previous HTA reports

15. Making the case The need for research:
How will patients and the NHS benefit from the proposed research?
Consulting with panels of clinical and patient representatives
Include a clear HTA research question using ‘PICO’:
Population: NHS target population i.e. real patients
Intervention: A technology that is or could be used now in the NHS
Comparator: Usually next best treatment, but could be placebo
Outcome: Patient centred, leading to effectiveness and cost-effectiveness
Include a summary of the burden of disease
Incidence or prevalence
Mortality and quality of life
Describe the place of the technology in the care pathway
Include a thorough summary of current research

16. Choose a robust methodology
Systematic reviews (Evidence syntheses)
Randomised trials
Broad eligibility =
generalisable result /recruitment
Secure central randomisation
Blinding
Complete follow up
Accredited trials unit

17. Sample size: Credible effect size Include least important effect size
from literature
by analogy
from experience
Include least important effect size

18. Outcomes: Define your primary outcome Patient centred
Not surrogates, except established
Not composite, except by convention e.g. QALY

19. Feasibility: • Not over-complex
• Describe recruitment rate, to include:
Number of centres
Number of eligible patients
Issues around patient consents
Method of patient follow-up
• Demonstration of the necessary skill mix, experience, project management and infrastructure for success.
• Clinical and methodological experts
Link with Clinical Trials Units
Links with Clinical Research Networks

20. Feasibility Identify potential collaborators
Survey Monkey
Test eligibility rate in your centre
Test your methods in a randomised, multicentre pilot/start up phase

21. Cost effectiveness Is it necessary?
Justify if no health economics included
Include a full description of methods of data collection and analysis

22. Value for money
This should be proportional to the cost of treatment and importance of outcomes
? Less than £2.5 million

23. Presentation:
• English for mixed audience – clinicians, methodologists, patients and the public
• Tell the story well for the non - expert
• Include a Plain English summary
• Follow standard writing guides here, not just in the publication.
• Use visible headings, e.g. sample size, outcomes, technologies
• Space the proposal well, using clear paragraphs
• Flow diagrams
Consort type – check these include sufficient detail
Use where appropriate to explain complex interventions

24. What else can you do to gain insight into submitting a successful application?
► Ask for advice from the HTA programme
► Offer to peer-review - see how others write grant applications
► Speak to active HTA researchers, especially Clinical Trials Units