Clinical Study Grants

For clinical trials and observational studies of specific patient groups costing more than £300,000 or lasting more than 3 years.

Award specifications

The clinical study grant supports funding for over £300,000 for:

  • Interventional clinical trials: trials of specific interventions or pathways of care for the prevention, diagnosis and treatment of cardiovascular disease. Interventions include drugs, surgery, devices, psychological, physical and educational interventions.
  • Observational studies of specific patient groups that are hypothesis led and address a defined clinical question(s) over a fixed timescale (up to 5 years). The population of interest should be a patient population, who will usually be recruited within the NHS. The study should have a predefined outcome(s) that will lead to changes in clinical management directly or will inform the development of a clinical trial to test an intervention.
  • Clinical studies can include a mechanistic evaluation, either as a substudy within a clinical trial or as part of an observational study.

The scheme does not support funding for population based cohort studies or patient based cohort studies focusing on open ended epidemiological questions, or whose main focus is genetics/genomics or other omics analyses (please apply for either a Special Project Grant or a Programme Grant). For programmes of experimental medicine or programmes of clinical research, please apply for a Programme Grant.

Clinical Study Grants cannot be renewed.

If you are unsure which scheme is appropriate for your clinical study application, please contact us.

Entry requirements

  • The principal investigator will be a senior researcher working in an established research institution in the UK. S/he must have a strong track record of grant support, usually from us, and an internationally recognised research profile.
  • Any multicentre interventional clinical trial, while remaining under the scientific control of the principal investigator, should usually be managed by a UKCRC-registered Clinical Trials Unit (CTU) and should usually include a member of the CTU as a co-applicant or principal investigator unless there are clearly justified reasons for not doing so.
  • For multicentre observational studies, applicants should consider a mentorship arrangement with a CTU. We will judge the need for this arrangement on a case by case basis.

Grant duration

  • Usually up to 5 years, with regular progress reports, initially annual reports. We may consider a staged award based on proof of adequate recruitment and progress.

Award may include

  • Staff salaries. For example: research fellow, clinical trial co-ordinator, research nurse, where fully justified.
  • Research consumables directly attributable to the project.
  • Research equipment essential for the project.

International collaborations

Studies funded by the BHF must have a UK-based principal investigator. The BHF will consider applications for international studies where the chief investigator and lead institution are based in the UK and the study is relevant to the UK population. Funding for that part of the study carried out abroad should be sought from the overseas investigators, although exceptionally the BHF will consider funding the overseas arm(s) of a UK led study.

The BHF will also consider proposals to support the UK recruitment arm of an internationally led study where the study is relevant to the UK population; again, a UK-based principal investigator is required.

Each project will be considered on a case by case basis and applicants interested in submitting a proposal for an international study should contact us for advice.

Co-funding arrangements

BHF is prepared to consider joint funding arrangements, including the possibility of jointly funding studies with international agencies.  Joint funding requests will be considered on a case by case basis. You should contact us to discuss your proposal before applying for funding. 

How to apply

Applications are assessed in a two stage process: an outline application followed by a full application if the outline is successful. Outline applications are considered throughout the year, and you will usually receive a decision on submitting a full application within 9 weeks of the outline submission.

Full applications will be assessed by the Clinical Studies Committee, which meets twice a year.

Outline proposals

The first step involves review of a preliminary outline of the study. Please complete an online preliminary application form following the instructions in the GMS User Guide

Additional information

You will be asked to attach a single PDF document to your online application form. This should contain the following information:

  1. Project title

  2. Proposed start and end date and duration (in years and months)

  3. Name, Department and Institute for each co-applicant (maximum of 10 co-applicants allowed)

  4. Abstract of the proposed investigation in 200 words or less.

  5. Background to the study

    Include:
  • A description of the health problem being addressed.
  • Why the research is important to people affected by, or at risk of, cardiovascular disease.
  • What is already known about the topic (include how previous studies, meta-analyses or systematic reviews support the proposal).
    Further guidance:
    It is especially important to describe the available evidence for efficacy and safety of any proposed intervention. If there are known adverse effects leading to non-adherence, this will need to be taken into consideration when calculating sample size.
  • Why the study is needed now.
  • What the study will add and how it is novel.
  • How the study might impact on clinical practice.

    6. Hypothesis to be tested

    7. Study design

Summarise the proposed design and justify each of its elements, as follows:

  • Setting: describe the clinical setting in which participants will be identified and invited to participate (e.g. general practice, hospital outpatients, ambulance service users).
  • Target population, including key inclusion/exclusion criteria and any relevant details about how that population will be selected (e.g. after a run-in period).
  • Intervention and comparator.
  • Methods for allocation concealment (randomisation method).
  • Blinding of treatments (where appropriate). State whether the trial will be placebo controlled. If not, explain how you will avoid the potential for bias in assessing outcomes (e.g. perhaps by using patient registries to identify outcomes).
  • Primary and secondary outcome measures. State the main outcomes only and explain briefly why they were chosen.
  • Methods for maintaining drug adherence, ensuring reliable capture of outcomes, and avoiding losses to follow-up.
  • Outline description of data analysis. Give a very brief summary of the method of analysis and explain why it was chosen, but note that a detailed analysis plan is not required.

    8. Sample size calculation

Provide a proposed sample size, describing the event rate (which should be based on contemporary data) and explaining how it was estimated. Give a detailed justification for the event rate, estimated effect size, power and type 1 error rate.

Further guidance:
When estimating effect size, bear in mind that for a binary clinical outcome most treatments have at best moderate effects (e.g. a 15-20% relative risk reduction). An effect estimate larger than this will need careful justification. (Note: since the results of systematic reviews of small trials are known to overestimate effect size, such studies are not generally suitable for determining the likely effect size of a treatment in a new trial.) Where sample size requirements exceed the capacity of the UK, the BHF encourages applicants to consider seeking international collaboration.

    9. Evidence of feasibility

Explain how you have assessed the feasibility of the study, giving details of any pilot work to establish trial methods and numbers of available participants, the existence of equipoise for the study question, the numbers of sites (including internationally, where relevant) that have given ‘in principle’ agreement to collaborate, and contemporary event rates. If international sites are involved, give details of the proposed UK and international recruitment targets.

Further guidance:
Since many trials fail due to difficulties in recruitment, it is important to provide substantive evidence of feasibility at the outline stage. This will preferably include pilot data, and the BHF encourages applicants to consider conducting a pilot study before applying for funding for a definitive trial. Such pilot studies may be submitted as a stand-alone application, or as a ‘vanguard’ phase in an application for a larger trial, with full funding contingent on satisfactory milestones being reached within the vanguard phase.

    10. Study management

Explain briefly how the study will be managed and the name of the registered clinical trials unit managing the study.

   11. Project timetable

Outline the main stages of the proposed study and the expected duration of each. 

   12. Summary of costs

Provide a categorised summary of total expected costs and anticipated contribution from NIHR CRN, its equivalent in the devolved nations, or any other funder (e.g. drug company). If other funders are involved, provide details of the status of funding applications and amount requested from each funder.

See Costing a Clinical Study for further information.

   13. Flow chart

Supply a flow diagram illustrating the study design and the flow of participants. The flowchart should be in a PDF format and not PowerPoint. Complex interventions and controls should be described as accurately and fully as possible within the diagram. If proposing a randomised controlled trial, please refer to the CONSORT statement and website for guidance.

   14. Key references

List a maximum of 10 key relevant references.

   15. Commercial collaborators

Give the name and type of contribution from any commercial collaborator (e.g. drug company) if relevant. See BHF Commercial Company Guidelines for further information.

   16. Previous or parallel applications

Please note if there are other funding bodies and / or BHF committees that have considered / are considering any part of this application. Please indicate how the current research proposal differs from any previous/parallel application. If a resubmission, outline briefly why the previous application was unsuccessful.

   17. Grants and publications

List relevant grants held and publications for the principal investigator.

Sections 1-11 together must not exceed 5 A4 sides, and sections 12-17 must not exceed 1 A4 side each.

Please use Arial font size 12 or the application will be rejected prior to formal consideration.

Full applications

Once a preliminary application is approved you should submit a full application:

Additional information

You will be asked to attach a single PDF document to your online application form containing the following information:

  1. For resubmissions, include an unedited copy of the original feedback and your original rebuttal, followed by a detailed response, limited to 3 sides of A4, explaining how the revised application has changed from the original submission.
  2. Abstract of the proposed investigation in 200 words or less.
  3. Background to the project. Include an explanation of what health problems are being addressed and the clinical impact of these health problems. Include details of systematic reviews and ongoing trials that are relevant to the proposed study.
  4. Scientific principles/rationale underlying the proposed research. Explain if the application addresses a novel approach.
  5. Hypothesis to be tested.
  6. Questions to be addressed.
  7. Pilot data. Provide details of the results of all pilot and feasibility studies that support the full study.
  8. Study details including all information listed in the Clinical Study Guidelines (Interventional Study) or in the Clinical Study Guidelines (Observational Study)
  9. Expected value of results.
  10. List of key relevant references.
  11. The contribution to be made by each co-applicant and collaborator (maximum of one A4 side).
  12. List of principal investigator’s and co-applicant(s)’ relevant publications.
  13. Brief CVs (2 A4 sides including e-mail address) of named staff for whom salary is requested.
  14. Supporting letters from collaborators.
  15. Quotes obtained for relevant equipment.
  16. Valid copy of ethical approval.

Please also complete the following forms and include them in your application PDF:

For resubmissions, please ensure you have updated the Plain English Summary and PPI sections.

Sections 2-9 must not exceed 10 A4 sides. The PDF file size must not exceed 20MB.

Please use Arial font size 12 or the application will be rejected prior to formal consideration.

Decision process

Outline applications

Outline applications will be reviewed throughout the year. If your outline application is approved, you will be invited to submit a full application.

We ask that you allow up to four weeks for your outline to be considered as well as sufficient time to prepare a full application after receiving feedback. This means that outline applications submitted after the 9th July 2018 will not qualify for a full application submission to the November 2018 committee, but will need to be submitted to a committee in 2019.

Full applications

There are two funding rounds a year for full applications for Clinical Study Grants; the cut-off dates for full applications for 2018/19 are no later than 5pm on:
  • Wednesday 15th August 2018 for the November 2018 Clinical Studies Committee
  • Wednesday 30th January 2019 for the May 2019 Clinical Studies Committee
  • Wednesday 31st July 2019 for the October 2019 Clinical Studies Committee.

We will acknowledge receipt of your application within 24 hours and we will advise when you can expect the result.

Please ensure you leave sufficient time for your application to be approved by all signatories when submitting via GMS.

A decision will be reached by the Clinical Studies Committee, which meets twice a year (in May and October/November).

If your full application is rejected, you may be allowed to reapply. If you reapply within 6 months of the committee decision you can submit a revised full application omitting the outline stage. If you intend to reapply 6 months or later after the committee decision, you will need to submit an outline application for approval first.

As Clinical Study Grants are rarely awarded without revision, the application should usually be submitted around 12 months before the expected start date.

 

Apply online