HTA Clinical Trials - troubleshooting

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 NCCHTA offices so they can be assessed. Submission deadlines are stated on the website.

If I am not eligible for HTA Clinical 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.

Are only projects based in England suitable for this funding opportunity?

No, this funding is not limited to applicants based in England (or even the UK).  Indeed the HTA programme funds proposals from outside the UK when this is the best method of meeting an NHS research requirement and a clear case has been made.

I cannot see a relevant section for a trial protocol to be inserted.

The outline proposal form is all that should be completed and submitted for HTA Clinical Trials. We do not require detailed trial protocols at the initial stage.

Are references expected in an outline application and if so where should they go?

Our outline proposal form is all that we require - if you have room on your form for references you are welcome to include them, but if you are short of space they are not essential.

Assessment process

Do you give feedback on proposals?

We are unable to provide feedback to those outline proposals that are not shortlisted for further consideration. Feedback is provided to shortlisted outline and all full proposal applicants.

How do you choose referees who assess the proposals?

We choose from our ‘college’ of referees. The criteria for entry includes job seniority, recommendation by other recognised experts, recommendation by senior NCCHTA staff or HTA programme advisors, or suggestion by the head office of a professional or charitable society.

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 HTA Clinical Trials?

HTA Clinical Trials does not encourage resubmitted outline proposals from researchers. However if you intend to do so then please download the latest version of the application form and associated brief 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 HTA Clinical Trials are not successful:

• Applications are not within the remit of this funding stream (see the brief 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. We received over 350 applications to the first two closing dates for this funding stream.

Pilot and feasibility studies

Will you fund pilot and feasibility studies?

We do fund these - but only as part of an application for a wider trial or study. The funding mechanism for stand-alone pilot studies in England is through the Research for Patient Benefit (RfPB) programme

Questions asked by potential applicants

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.

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.

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

Strictly speaking this study may not be a clinical trial as no comparisons would be made. We are happy to consider evaluations of diagnostic technologies and recognise that they may require study designs other than an RCT.  The researchers should justify their choice of study design in their application.

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.

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 Clinical Trials work stream. Outline proposals can be submitted at any time. Commenting on a vignette will not in any way disadvantage an application to the HTA Clinical Trials work stream. 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 Trials work stream. Does this represent a conflict of interest?

Experts who have submitted or are planning to submit a proposal for the HTA Clinical Trials work stream 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 Trials work stream 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 Trials work stream?

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 Trials work stream.

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

There are a number of reasons why a proposal for the HTA Clinical Trials work stream 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 work stream 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 Trials work stream.

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.

 

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