Research Design Service: East Midlands
National Institute for Health Research

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Efficacy and Mechanism Evaluation (EME) funding tips

  Created on Tuesday, 13 Dec 2016. Posted in Funding Tips

Aims:

  • Funds ambitious studies evaluating interventions that have the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care.
  • Includes hypotheses-driven research to improve the understanding of the mechanisms of both diseases (natural progression of disease) and treatments (interaction between treatment and disease).
  • Supports translational researchinto a wide range of new or repurposed interventions.
  • Funds clinical validation studies of diagnostic tests which have been developed and are known to work in the lab.
  • Standalone mechanistic studies can be funded as long as they are added onto an existing NIHR funded study.

Innovative study designs involving stratification, the use of routinely collected digital data or novel methodologies are strongly encouraged.

Funding:
Average cost £1 million (£150,000 - £3 million) over an average duration of 42 months

Remit query:
Send an A4 summary in PICO format (with intro and background) to the panel to see if in remit

  • Population you are interested in
  • Intervention
  • Control treatment
  • Outcome measure you are using

Tips for success:

  • Design:
    Study should be optimised around the most important research question.
    Clear rational, show what is known and unknown in the research area.
  • Team:
    Appropriate skill mix, with a credible mix of clinicians, applied health researchers, statisticians, experts in study design, patients and project managers.
    Co-investigators should be making a clear contribution without duplication to demonstrate value for money.
    Evidence of good research track record provides confidence in the team.
    Important to have CTU input from early in the development stage.
  • Outcome measure:
    Choose a primary outcome that is patient centred and reflects the study question.
    It is important that you can measure the outcome in all people in the study.
  • Pilot data:
    It is important to provide relevant existing data about the population to be studied and your primary outcome measure to justify the study.
    The panel is interested in information about the incident of the disease in the population, where possible the anticipated effect size of the intervention and likely recruitment numbers. Such data can all be used to justify the sample size.
  • Sample size:
    Always justify your sample size, give enough information so that the sample size can be reproduced and is easy to understand.
    Make sure the effect size is sufficient to change practice and is clinically meaningful and credible.
  • Recruitment plan:
    Provide a detailed recruitment plan based on data.
    Make sure you are looking at numbers who have the condition and fit the study eligibility criteria.
    Very few trials manage to recruit more than 50% of eligible patients!
    Include an allowance for loss and put in place measures to minimise losses (losses have the potential to create bias).
    Involve patients in developing measures to minimise loss as they have a good insight into what’s achievable.
  • Mechanistic evaluation:
    Not all proposals have a mechanistic element but when they do they should be hypotheses driven and aimed at (1) advancing scientific understanding of a clinical condition or therapy action or (2) furthering advances of health outcomes for the patients.
    Mechanistic evaluations need to have the same rigour in design and clear objectives to the same standards as the efficacy evaluation part of the study.
    Often mechanistic evaluations fail to meet the EME remit by being far too exploratory, focusing on biomarker discovery or failing to have the correct team in place.
  • Finance:
    Show good value for money.
    Provide a realistic estimation of cost - don’t over estimate staff costs and underestimate non-staff costs, placebos can be expensive!

Health Technology Assessment Funding Tips

  Created on Monday, 07 Nov 2016. Posted in Funding Tips

HTA the largest of the NIHR programmes and is the last stage in the translational pathway. The scheme funds definitive studies looking at effectiveness, costs and broader impact of healthcare treatments and tests.

There are no fixed limits on duration or funding but value for money must be demonstrated. The application process can take of 12 months and there is a 25% success rate for second stage submissions.

To be successful in getting funding you’ll need to convince the panel of the:

Health Impact
Quantify the health burden, how many people are eligible to use the new intervention (rare conditions research can be funded if there is a severe impact to health that would be improved by an intervention).
Quality of life is very important as many people have co-morbidities. Years gained and outcomes of ‘major events’ are all important measures (lives saved often inappropriate).

Economic Impact
The panel isn’t interested in how much the disease costs, so much as how much could be saved by the intervention. It is hard to get data on impact measures such as changes to NIHR staffing, equipment, training etc but they’d all be relevant.
Impact on society can also be used here ie an intervention that could enable patients of working age to go back to work or increase productivity.

Clinical Importance
The research question must be important to clinicians. Ideal is if you can show variation in clinical decision making or show an uncertainty in clinical guidelines as this provides a powerful evidence of need.
If research recommendations aren’t available it is possible to generate them yourself by carrying out surveys and priority-setting exercises.

Value for Money
Cost per patient recruited good marker to see if the research is worth the cost (>£1,000 per patient). Trials costing more than £2-3 million need to be really important or show big impacts. However trials need to be deliverable for the money so if you cost too low your bid is also likely to fail.
When justifying the cost make is clear and explicit how it will work – flash statements won’t work, they need to be backed up with arguments.

Public Involvement
If you get public involvement wrong you won’t get funded. So ensure you are measuring patient centred outcomes to give you the best chance to recruit patients and minimise drop out during the trial.
Make sure you have solid feedback and dissemination plans in place.

Tips for success:

Team:

  • Show that your team can answer the research question by detailing your track record in both the science and delivery of trials.
  • Make sure the team has the appropriate skill mix to deliver the trial and explain who is going to do what to justify money and time allocated to each team member.

Outcome measure:

  • Your primary outcome has to be in line with the research question. Ensure the link is very clear to convince the panel, add an explanation if needed.
  • What difference in the primary outcome will the trial detect? Be realistic and honest – is it important and is it deliverable?

Scientific quality:

  • Provide a good theoretical justification as to why the intervention is a good fit for the group/disease. Give enough detail to avoid second guessing.
  • Clearly specify qualitative research and health economics elements avoiding formulaic statements. You’ve included them for a reason so tell the panel why they are important elements.
  • Mention appropriate systematic reviews, show the panel that you are aware of where your research fits into the current body of evidence.
  • Mention pilot work if available to reduce uncertainties in trial delivery.

Trial stages:

  • Integrate the different stages of your study plan, showing how they weave together and how outcomes of stages will lead to a decision pathway.
  • Provide a flow diagram showing the patient pathway (with exclusion and inclusion criteria) of what treatment and what monitoring will be provided.
  • It is important to provide a trajectory with feasibility studies, indicated stages to mark success and progression.
  • Be open about problems with the trial – the panel will spot them so be open and suggest possible solutions.

Public Involvement:

  • Show that you know the value of public involvement. Demonstrate patient- centred outcomes and how patients have been involved in the study design.
  • Highlight how patient involvement has influenced the design of the study and how they will continue to provide input throughout the trial.

Finance:

  • Provide letters of support from the centres that have been signed up for the study, should it be funded.
  • Make sure you include enough centres in the study.

Lead-writer:

  • Get one person to be the lead-writer of the application as this avoids a patchwork effect and the bid will be more coherent.
  • Make it easy to read and avoid acronyms
  • Avoid cut and paste statements of importance from disease specific documents/websites.
  • Avoid shoe-horning your research idea into a commissioned call and stick to the brief!
  • Get your work peer reviewed to check for clarity and consistency between sections.

NIHR Fellowship tips

  Created on Thursday, 16 Jun 2016. Posted in Funding Tips

The following documents tips and highlights from the NIHR Fellowship webinar (16 June)

Tip 1: You must demonstrate impact in your application
Fellowships like any other NIHR funded projects have to fall within the remit of the NIHR. This means that they have to be people based, applied health or social care research projects with the potential to have impact on the needs of the public within 5 years of completion.

Tip 2: Demonstrate that you have the commitment and potential to be a leader
The NIHR ‘fellowships for all’ are aimed at doctoral level and above and are personal research training awards. They require various levels of experience and research outputs but the panels are all looking for evidence of a candidate’s commitment to a research career and their potential to inspire others and become a future leader.

Tip 3: Embed public involvement throughout your application
As with other NIHR funding streams the fellowships take public involvement very seriously. It is important not only that you have thought about involvement but it needs to be woven throughout your application and not added as an afterthought! The RDS administers a small Public Involvement Fund award which can be used to enable early public involvement activity in the design process and may serve to strength your bid substantially.

Tip 4: Have you application peer reviewed!
Remember the plain English summary is the first thing that the panel will be reading. You need to make sure that it’s well written and concisely conveys your ideas. Something that is being advised more and more is to have your application peer reviewed, be it by supervisors, senior academics, mentors, colleagues or the RDS. Constructive feedback will only prove to strengthen your application and get you thinking about the issues that your project faces from a different perspective. Ideally you’d resolve any flaws before submitting to the panel giving your application the best chance of success.

Tip 5: Do your research and look at past funded fellowships and feedback documents
Of course it always helps to know your audience. The NIHR TCC website holds lists of previous award holders, panel members and funded topics. There is also a collection of chaired reports from the panels which list general feedback on common mistakes made in applications. The recent fellowship webinar which inspired this blog along with audience questions is also posted on the site and can give you vital background information to inform your application.

More generally fellowship application success depends on 5 areas: PPPTS
P – Person:
Where are you in your research career? Your CV, outputs and network/collaborations will all create a story and need to show your journey towards a research career. Sometimes you may need to do some additional work to make yourself fellowship ready! But remember that outputs are not exclusively journal publications they can be posters, conference presentations and other engagement activities.

P – Project:
As with other funding streams you’ll need to demonstrate a need for the research and show that the methodology suggested will answer the question. Very important is that it is achievable within the timeframe. Evaluation is also an important part of the project.

P – Place:
Pick the right place for you - ask: Is this a leading centre for my type of work? Do they have experience of successful NIHR fellows?
You need somewhere that has a good name but also shows commitment to helping researchers develop their career.

T- Training:
The fellowships are research training awards and as such training plays a vital role in the application. The training must be at the appropriate level and can vary from training in a specific skill or method to help with your research project; to management and leadership training so that you can inspire others. The timing of the training is also really important and should be scheduled before you need the ‘new skill’ in the project. It is also encouraged that candidates think outside the box and search for appropriate external sources of training rather than stick to what is offered by their hosting institute.

S – Supervision:
Don’t choose your supervisor as an afterthought – you have to work long periods together and they need to have the time to support you. It is possible to have more than one supervisor and they can be from different locations, however each must bring something unique to the table that will help support your mentorship.

Fellowships are about the development of a person.
Applications need to show how gaining the award will have an impact on you and take you to the next step of being a research leader.

Writing an application takes time so get in touch with your RDS as soon as possible to talk over which fellowship would suit you best and get the ball rolling. For those that get invited to interview RDS can provide you with a mock interview experience so that you are fully prepared on the day! Our panel will put you through the rigours of an interview and ask the tough questions that you might be faced with on the day.


The renewed NIHR Research for Patient Benefit programme

  Created on Thursday, 21 Apr 2016. Posted in Funding Tips

The following is a summariy of Professor David Armstrong's key points on the renewed programme!

RfPB is a small grants programme with the top limit of £350,000 for projects. It is seen as a conduit to the bigger programmes such as HTA and PHR.

  • Upper limit of £350,000 for research with a clear and close trajectory to patient benefit
  • Soft ceiling of £250,000 for feasibility studies (these are essentially de-risking studies for future trials. Recruitment is a major problem for trials and so having a small feasibility study to see if it’s doable is worthwhile even if the answer is 'no' as it can save a lot of money down the line)
  • Higher risk (further from patient benefit) cost less than £150,000. These are studies that are upstream and will need further studies before they provide patient benefit.

High risk studies that are open ended and inductive in approach aren’t what the funding stream is looking for. However below is a list of examples that would be considered:

  • Observational studies
  • Developing and refining interventions
  • Developing new scales or outcome measures
  • Exploratory studies that might provide insights into an intractable problem
  • Additional follow up of patients in a completed clinical trial
  • Post-market surveillance for unknown side-effects of a drug (Phase IV trials)
  • Systematic reviews where the number of relevant studies is likely to be limited

RfPB is also seen as a programme that previous fellowship applicants can access and new investigators can be named as the PI on the bid as long as they are part of a solid team.
Panels will be looking at the bids and judging:

  • Do we like the research?
  • Can this team deliver it?

The new 2 stage application process has been introduced to try and make the process easier to access and to speed up the pace of the whole application process.

At stage 1 only half of the application process needs to be completed – aim/question, background and methods.
The panel at this stage is looking at:

  • ‘are we interested in this question?’ and
  • ‘can it be answered using these methods?’

Formative feedback will be given to successful projects on how to improve the bid to have a better chance of success in the second stage. It’s very important that researchers act on the feedback.

The turnaround to the second stage is only 4-6 weeks but submission can be deferred to the next round if there are issues getting the costings sorted. With the new system the programme is hoping to have a 50% success rate of those submitting to the second stage.

Patient involvement and benefit has always been central to the RfPB but rather than being constrained to the public involvement section of the application form the panels are being encouraged to broaden what is considered. Projects that answer the following questions in their bid are more likely to be reviewed positively.

  • Would an answer to the question be important to patients?
  • Are outcome measures relevant for patients?
  • Is the burden of being in the study acceptable?

The programme director has also heavily emphasised the importance of avoiding ‘me too’ applications. He describes these as one arm bandit applications where a known intervention is applied to a new disease or different population. These applications are increasingly being seen as a waste of money – applying logic to the situation can often predict the answer without any need to do the research. The examples he gave were CBT or exercise having a proven effect and so there is no need to trial it for every disease in every population to know that it will probably provide some improvement.