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 cohorts (please apply for a Special Project Grant), programmes of experimental medicine or programmes of clinical research (apply for a Programme Grant for such studies).

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

Most studies funded by the BHF are UK based. The BHF will consider funding the UK arm of an international study where the chief investigator and lead institution are based in the UK and the study is relevant to the UK population, and where overseas recruitment is funded from other sources.

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; a UK based principal investigator should be the lead applicant.

In exceptional circumstances, the BHF will consider funding recruitment overseas.

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 a month of the outline submission.

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

Preliminary 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 containing the following information:

  1. Project title.
  2. Name, Department and Institute for each co-applicant.
  3. Background to the study including an explanation of its importance and novelty.
  4. Hypothesis to be tested.
  5. Study design, sample size, power calculations and outcome measures.
  6. Evidence of feasibility of target recruitment.
  7. List of key relevant references.
  8. Categorised summary of total expected costs and anticipated contribution from NIHR CLRN, its equivalent in the devolved nations, or any other funder (e.g. drug company). See Costing a clinical study for further information.
  9. A list of relevant grants held and publications for the principal investigator.

Sections 1-6 together must not exceed 4 A4 sides, and sections 7 and 8 must not exceed 1 side each. Section 9 is limited to 1 side.

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 previous feedback and provide a detailed response explaining how the revised application has changed from the original submission.
  2. Abstract of the proposed investigation in less than 150 words.
  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. List of principal investigator’s and co-applicant(s)’ relevant publications.
  12. Brief CVs (2 A4 sides including e-mail address) of named staff for whom salary is requested.
  13. Supporting letters from collaborators.
  14. Quotes obtained for relevant equipment.
  15. Valid copy of ethical approval.

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

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

There are two funding rounds a year for full applications for Clinical Studies; the cut-off dates for full applications are:

  • Wednesday 1st March 2017
  • Wednesday 16th August 2017

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

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

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

 

Apply online