Global Cardiovascular Research Funders Forum

The GCRFF Multinational Clinical Trials Initiative provides a mechanism to better coordinate the consideration of investigator-led multinational clinical trials by a group of national funders. The initiative does not fund trials directly, nor does it guarantee funding by individual funders.

The Multinational Clinical Trials Initiative engages a subgroup of the GCRFF membership whose aim is to facilitate the coordinated consideration of investigator-led multinational clinical trials by national funders. It includes the following members:

• British Heart Foundation
• CIHR Institute of Circulatory and Respiratory Health, Canada
• Dutch Heart Foundation
• German Centre for Cardiovascular Research
• National Heart Foundation of Australia
• National Heart Foundation of New Zealand
• NIH National Heart, Lung, and Blood Institute (NHLBI), United States
• Swiss Heart Foundation

The initiative provides a way for investigators to submit a single Expression of Interest (EOI) for a multinational cardiovascular clinical trial for consideration by GCRFF members for endorsement. The endorsement of an EOI by the GCRFF is an indication of strong support by the GCRFF members for the proposed trial. Investigators can then seek funding to support the trial through relevant national funding schemes (including members of GCRFF and non GCRFF member funders).

The aim is to help investigators in different countries collaborate more effectively and plan ambitious, practice-changing clinical trials that deliver results successfully. It also helps researchers collaborate on global clinical trials that might not be feasible in a single country or with support from a single funder alone. The initiative helps to achieve this in the following ways:

• It allows individual GCRFF member funders input into the trial design at the outset, in contrast to the current situation, where additional funders are often approached late after initial support for the trial has been secured from one funder, and the trial has already started.
• It reduces the risk to the funder(s) by providing greater assurance that the trial will be deliverable and costs will be shared.
• Knowing from the offset where the trial will be conducted, its full sample size, and the totality of funding requested will help national funders make informed decisions on whether to support the final application.
• Furthermore, funders can make their decision about a final application conditional on the trial being funded in enough countries to make it viable. If enough funders are prepared to support the trial, the trial can begin at or near the same time in different countries making it more likely to succeed and be delivered in a timely fashion.

Deadlines and Expert Advisory Panel dates can be found on the British Heart Foundation’s webpage.

How It Works

Investigators wishing to participate in the initiative should follow the following process:

Investigators can submit an Expression of Interest (EOI) for a multinational trial through a dedicated portal. EOIs must meet specified eligibility criteria to be considered.

Submitted EOIs are assessed by an independent international Expert Advisory Panel that will serve to recommend EOIs for endorsement by the GCRFF.

Following GCRFF endorsement of an EOI, investigators in each country collaborating on a trial can then prepare their application in a coordinated manner by outlining the relevant component of the trial, and seek the financial support needed by their respective national funder (as appropriate). The application for funding support consideration, following an EOI endorsement, will follow the national funder’s funding mechanism application and peer review process. Please review the information on relevant funding schemes to learn more about how clinical trials are being supported by members of the GCRFF Multinational Clinical Trials Initiative.

The scientific rationale and trial design is expected to be uniform across all applications.

Criteria for Submitting an Expression of Interest

The principal investigator should be a senior researcher working in an established institution eligible to hold grant funding in a GCRFF member country. They must have a strong track record of grant support, and an internationally recognized research profile.

The trial should plan to test specific interventions or pathways of care for the prevention, diagnosis or treatment of heart and circulatory diseases. Interventions can include drugs, surgery, devices, psychological, physical, and educational interventions.

The trial should address an unmet clinical need of importance to people affected by, or at risk of, cardiovascular disease. Its results should have the potential to change clinical practice. There should be a clear need for a multinational trial to answer the clinical question. The investigators should be planning to conduct the trial in at least two GCRFF member countries.

The investigators can be planning to apply for funding from:

• Funders who are GCRFF members
• Both GCRFF and non-GCRFF member funders (investigators are encouraged to explore co-funding beyond the GCRFF members)
• Non-GCRFF member funders

The EOI must include co-applicants from the countries of the national funders who have been named in the funding request. Co-applicants should have been fully engaged in the development of the study, should have inputted into the EOI, and (should the EOI be endorsed) be planning to be fully engaged with the process of applying for funding in their respective countries.

It should be clear why the trial should be considered for support by national cardiovascular funders and not by others (e.g. pharma).

It is recommended that the investigators should have initiated discussions about the trial with relevant funding bodies in the countries where the majority of participants are planned to be recruited.

You will be asked to provide an estimated total cost for the trial, and indicative amounts to be requested from each proposed funder. While a detailed breakdown of costings is not required at this stage, the indicative costings should be a reasonable estimate of the funding required to successfully deliver the trial, and the amounts attributed to the individual funders should be realistic. The Expert Advisory Panel will take into account whether a trial potentially offers value for money when making endorsement decisions.

Please note: the remit of the initiative is to facilitate later phase, definitive clinical trials, and therefore early phase studies (Phases 1 and 2) are not eligible for the scheme.

Next Steps for Endorsed Expressions of Interest

If your Expression of interest is endorsed by the GCRFF Multinational Clinical Trials Initiative Expert Advisory Panel, you should apply for support for the proposed clinical trial through the national funders' usual funding mechanisms. Please note that while endorsement is intended to demonstrate support for applications to individual funders, it is not a guarantee of receiving funding if an application is made.

Frequently Asked Questions

Please review the Frequently Asked Questions page for more information.

How To Apply

Login to the portal via the British Heart Foundation Grants Management System. New users will need to register for an account before they can submit an Expression of Interest (EOI).

Please consult the How to Apply detailed instructions for more information.

Deadlines and Expert Advisory Panel dates can be found on the British Heart Foundation’s webpage.