HTA Clinical Evaluation and Trials- FAQ

Topic focus

What do you mean by Topic Focus?

The HTA programme regularly reviews the range of research studies we support.  In discussion with the Department of Health, we invite research proposals into the CET work stream in specific topic areas where there is a need for further research to be undertaken.  We call these ‘topic focus’ areas (formerly referred to as ‘strategic uplift’ topics).  To support the prioritisation of projects submitted in topic areas the HTA programme involves additional expert advisors.

My research proposal is not within the topic focus – will I be disadvantaged if I put my application in now?

No.  All projects submitted to the CET work stream undertake prioritisation in the normal way and are judged on their own merit.  The topic focus aims to encourage research in particular areas in which the programme wishes to invest, but this encouragement is not to the detriment of supporting research proposals in other topic areas.

Developing your research proposal

When is the next cut-off date for this funding stream?

Outline proposals are accepted on an ongoing basis. There are, however, cut-off deadlines for proposals to reach the NETSCC, HTA offices so they can be assessed. Submission deadlines are stated on the website.

If I am not eligible for the HTA Clinical Evaluation and Trials funding – where else might I go?

The HTA programme is part of the National Institute for Health Research (NIHR) which also includes several other funding programmes.

The Research for Patient Benefit (RfPB) programme may be of particular interest. Its main aim is to support both quantitative and qualitative projects in health services research and public health that are relevant to the NHS. It funds research that is related to day-to-day practice in areas identified and developed by health service staff which intends to:

• study the way that NHS services are provided and used
• evaluate whether interventions are effective and provide value for money
• examine whether alternative means for providing healthcare would be more effective in terms of cost and effectiveness
• formally assess innovations and developments in healthcare

Do you accept bids concurrent with applications to other organisations, e.g. the MRC?

No, we will not accept any proposal that is currently pending with another research funder.

Can I make changes to my submitted application?

No, once an application has been sent to the HTA programme you cannot ask for changes to be made to it. You can, of course, withdraw your application and resubmit at a later date.

I cannot see a relevant section for a trial protocol to be inserted - can you help?

The outline proposal form is all that should be completed and submitted for the HTA Clinical Evaluation and Trials. We do not require detailed trial protocols at the initial stage. If you are successful you will be invited to submit a full application form and submit a detailed project description at that stage.

From my understanding the health technologies don’t necessarily need to exist in current NHS practice but you need to be able to demonstrate that the new health technology could usefully become part of everyday NHS practice. Is this correct?

Yes.

Am I eligible to apply?

The NIHR Health Technology Assessment programme is funded by the NIHR, with contributions from the CSO in Scotland and NISCHR in Wales. Researchers from Northern Ireland should contact NETSCC to discuss their eligibility to apply.  If you have any queries regarding eligibility to apply we advise you contact us before completing an application form.

I was wondering whether the HTA programme would consider funding the UK "arm" of a tri-national study?

The HTA programme has no objection, in principle, to joint funding. The HTA programme would however need to be clear about where responsibility lay contractually in terms of publication, copyright, and research governance issues etc. These issues would need to be fully addressed at full proposal stage by the applicant if the outline proposal was shortlisted. At outline stage it would be sensible to refer to this arrangement briefly with a clear indication that further information would be provided at full proposal stage if shortlisted.

Would you consider proposals involving the use of complementary therapies in the clinical setting?

We would not exclude complementary or alternative therapies from the programme.  Trials on technologies of this sort would be assessed against the other research proposals we receive.  Research proposals should be designed to assess the effectiveness of technologies, not, for instance, the prevalence of their use. 

Would you fund a technology under development?

The HTA programme is not in a position to fund technologies that are still being developed, nor would the programme fund research with a view to creating a market.  We would require the technology to be freely available to collaborating centres, ie probably already marketed in the NHS. A research proposal for a developing technology may be better placed with the health technologies portal.

Would the HTA programme consider research on diagnostic technologies, e.g; to evaluate and compare in a population-based study the diagnostic accuracy and potential value for screening of different technologies?

The HTA programme is happy to consider evaluations of diagnostic technologies. The HTA programme follows the NETSCC definition of diagnostic tests. To see this definition and to see which other NIHR programmes will fund diagnostic tests visit the NETSCC website glossary page.  

What happens if my HTA Clinical Evaluation and Trial application is rejected? Will my idea be used by others?

Applicants should not resubmit their application within twelve months of their original application. If the resubmitted application is unsuccessful but the topic is important, or if a revised application is not received at the next available call closing date once the twelve month period has elapsed, the HTA programme may, with the help of its prioritisation panels, review the potential for research in the topic area and may advertise for research proposals in this topic area. Previous applicants will of course be welcome to put in a proposal in response to this call.

Applicants should be aware that topics are suggested to the HTA programme from a variety of sources. So there are occasions when the same topic is being developed by the programme and coincidentally suggested by researchers. When this occurs both processes may be allowed to proceed in parallel.

We want to trial collection of questionnaire data from patients who have either sight, literacy or language difficulties. Is this included within the remit of your programme?

The proposed study is to enable wider participation in research and audit. This would be better suited to the NIHR Methodology Panel, or the Research for Patient Benefit (RfPB) programme. Our programme is seeking to evaluate technologies which have an identifiable benefit to health.

Would you consider funding a phase 2 trial?

No, phase 2 trials will not be considered.

What does it mean when my proposal is 'transferred'?

To help researchers take advantage of the fact that several NIHR programmes are managed by the same coordinating centre (NETSCC), we may on occasion, transfer an application from one programme to another.  We will coordinate the transfer of applications between programmes by contacting our colleagues in the relevant programme.

A transfer between NETSCC-managed programmes takes place where a proposal is rejected by the receiving programme as being out of remit but is, after discussions between the relevant Programme Directors, identified as being within remit of another programme. This may take place at any stage between initial remit check and consideration of the outline proposal by the relevant Board.

Transferring a proposal from one programme to another does not imply that it will be funded by the receiving programme – that will be a decision for the relevant funding committee at which the transferred proposal is considered. If your proposal is transferred you will be notified by NETSCC of the next steps.

 

Assessment process

Do you give feedback on proposals?

Because of the large volume of applications feed back is not generally given at the prioritisation stage. Feedback is provided to outline and all full proposal applicants considered by the Board.

What criteria will be used to assess my proposal?

All proposals received will undergo a two stage process of assessment. Firstly, proposals will be assessed by a panel to decide the priority of the topic to patients and the NHS. The panel will assess against the following criteria:

• The importance of the problem to patients and the NHS
• The outcomes chosen matter to patients and the NHS and the participants are representative of the case mix treated in the NHS
• There is a clear case for the proposed research with reference to the current evidence base
• The proposed study assesses the effectiveness and cost-effectiveness of a health technology

Proposals will then be considered as to their suitability for firstly short-listing and then commissioning against the following criteria:

• Scientific quality of the proposal
• There is a clear demonstration of the necessary skill mix, experience, and project management and infrastructure for success
• Explanation and justification for estimated recruitment rates
• Ethical, legal and social implications of the research proposed have been considered
• Reasonable costs

Can I resubmit my application to the HTA Clinical Evaluation and Trials?

The HTA Clinical Evaluation and Trials does not encourage resubmitted outline proposals from researchers. We will not accept a resubmitted application until 12 months have elapsed from the point at which you are notified of outcome by the HTA programme. If after this time you intend to resubmit your proposal then please download the latest version of the application form, guidance notes and associated specification document as we update these on a regular basis. If you are intending to resubmit you may be interested to know the main reasons why applications to the HTA Clinical Evaluation and Trials are not successful:

• Applications are not within the remit of this funding stream (see the specification document in our funding pages)
• Applicants fail to anonymise themselves sufficiently in the relevant sections of the application form (see guidance notes for further details). If you wish to reference your work or that of other co-applicants please use other sections of the form.
• Applicants fail to demonstrate a strong case for the importance of the research question and do not reference the current evidence base fully. The HTA programme is keen to see research priorities backed up by a recent systematic review or other strong published evidence.
• Competition within a strong field of applications.
  

 

Pilot and feasibility studies - Updated September 2010

What is meant by the terms 'feasibility study' and 'pilot study'?

The HTA programme defines feasibility and pilot studies in the same way as several other NIHR programmes. For this definition and to see which other NIHR programmes will fund feasibility and pilot studies visit the NETSCC website glossary page.

Will you fund pilot and feasibility studies?

The remit for HTA Clinical Evaluation and Trials (previously Clinical Trials) expanded in 2008.  As a result, the HTA Clinical Evaluation and Trials welcomes proposals for feasibility and pilot studies as well as proposals for evidence synthesis and clinical trials. Applicants that wish to include a pilot or feasibility study must ensure that the criteria for moving to a full trial are clearly specified.

The HTA programme defines feasibility and pilot studies in the same way as several other NIHR programmes. For this definition and to see which other NIHR programmes will fund feasibility and pilot studies visit the NETSCC website glossary page.  

Questions asked by vignette experts

I have developed a proposal for research in my area of expertise but have recently been approached to comment on a vignette on a similar topic that has been prepared for consideration by an HTA advisory panel. How would I obtain funding to do a trial in this same area? Will commenting on the vignette in any way disadvantage my proposal?

The HTA programme welcomes proposals for the HTA Clinical Evaluation and Trials workstream. Outline proposals can be submitted at any time. Commenting on a vignette will not in any way disadvantage an application to the HTA Clinical Evaluation and Trials workstream. It is not possible to be definitive on the priority that would be given to similar topics presenting at the same time from the two work streams. Each proposal will be assessed on its relative merits. The HTA programme will, of course, respect a decision not to comment on a vignette.

I have been asked to comment on a vignette for an HTA advisory panel but have already submitted a proposal on a similar topic to the HTA Clinical Evaluation and Trials workstream. Does this represent a conflict of interest?

Experts who have submitted or are planning to submit a proposal for the HTA Clinical Evaluation and Trials workstream should be reassured that commenting on a vignette would not be considered to be inappropriate or to present a conflict of interests. Experts are not requested to make a declaration of interests in this situation but may like to include a note that they have submitted or are in the process of developing a proposal for the HTA Clinical Evaluation and Trials workstream when forwarding their comments on a vignette.  

I have forwarded comments on a vignette but have not heard the outcome of this. Should I continue in forwarding my proposal for the HTA Clinical Evaluation and Trials workstream?

Experts who comment on a vignette will receive a letter notifying them of the outcome of the topic. This will be received approximately six months after they forward their comments. The reason for this delay is that following consideration by the advisory panel, the topic will be discussed by the Prioritisation Strategy Group which reviews all topics considered by the four advisory panels after each round of meetings and makes the final decision as to which topics will be referred for commissioning. In the meantime, the HTA programme would welcome proposals for the Clinical Evaluation and Trials workstream.

I have just been asked to comment on a vignette for a similar topic to a proposal I forwarded to the HTA Clinical Evaluation and Trials workstream which was rejected.

There are a number of reasons for why a proposal for the HTA Clinical Evaluation and Trials workstream may be rejected. A proposal may have been recognised as being important, but was not considered to be as high a priority as other proposals received at that particular time. In this situation, researchers will have the option to resubmit their proposal on another occasion.

Where a suggested topic is received for the original HTA workstream and is prioritised by one of the advisory panels, it will be allowed to progress through the programme, despite a similar topic being rejected through the HTA Clinical Evaluation and Trials workstream.

As noted above, in the event that similar topics present from the two work streams at the same time, it is not possible to be definitive on the priority that would be given. Each proposal will be assessed on its relative merits.

 

Unanswered questions

I have some questions not answered here – what should I do now?

Take a look at the FAQ pages for the funding stream you are interested in as further information is available on those pages.  If you are still unable to find the answer to your question then please contact us using the following details:

For HTA commissioned calls: please email your query to htacommissioning@soton.ac.uk

For HTA Clinical Evaluation and Trials: please email your query to htacet@soton.ac.uk

For HTA Themed Calls: please email your query to htatcall@soton.ac.uk 

 

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