International Clinical Trial Collaborations Program

Key Dates

2019 – Cycle 1

Wednesday 27 March 2019 (5pm ADST) – Minimum Data due on RGMS & submit Review Ready application to RIC.

Monday 8 April 2019 (10am AEST) – Submit final application to RIC

Wednesday 10 April 2019 (5pm AEST) – Final applications submitted to NHMRC

2019 – Cycle 2

Wednesday 31 July 2019 (5pm AEST) – Minimum Data due on RGMS & submit Review Ready application to RIC.

Monday 12 August 2019 (10am AEST)– Submit final application to RIC

Thursday 15 August 2019 (5pm AEST) – Final applications submitted to NHMRC

2019 – Cycle 3

Monday 4 November 2019 (5pm ADST) - Strategic review of Grant Proposal only

Wednesday 20 November 2019 (5pm ADST) – Minimum Data due on RGMS & submit Review Ready application to RIC.

Monday 2 December 2019 (10am ADST) – Submit final application to RIC

Wednesday 4 December 2019 (5pm ADST) – Final applications submitted to NHMRC

* Dates for subsequent years will be provided when available.

Contact: Bow Tauro, bow.tauro@unimelb.edu.au, 90354724

Supporting Documents

Relevant documents including the ICTC guidelines, application template and category descriptors can be found on the Grant Connect GO1737 webpage.

University of Melbourne researchers can also download the additional Information Pack prepared by the UoM MRFF Team (UoM login required).

Overview

The ICTC Grant opportunity will provide support for Australian research teams to conduct clinical trial research in collaboration with international counterparts. The clinical trial should not have commenced recruitment at the Australian trial sites. Support may be sought for new treatment arms of existing international collaborative clinical trials and for new questions within adaptive platform trials. Australian trial sites must be essential to achieving the outcomes of the clinical trial, or to confirm the relevance of these outcomes to health care in Australia.

Applications to this grant opportunity must propose a single clinical trial that will achieve the following outcomes.

  • promote Australian involvement in international collaborative investigator-initiated clinical trials research through the establishment and co-ordination of clinical trial site/s in Australia; and
  • provide high-quality evidence of the effectiveness of novel health treatments, drugs or devices in ‘usual care’ settings, which will support a decision on whether to deliver the intervention in an Australian setting.

Novel health treatments include new and innovative applications of existing interventions.

Examples of research that is not considered relevant to the desired outcomes include, but are not limited to:

  • pre-clinical studies
  • phase I and phase II trials
  • post-market monitoring
  • behavioural interventions
  • preventive healthcare

Applications where international collaboration provides for the successful conduct of clinical trials that may otherwise not be feasible in Australia are particularly encouraged (for example, due to low prevalence in the Australian population or because a large scale is required to identify meaningful effect differences). In such circumstances applicants must demonstrate how the benefits of international collaboration will be utilised: it is reasonably expected that the total number of participants will be at least double that recruited via the Australian clinical trial sites.

Where applicants are proposing to lead an international collaborative clinical trial, MRFF funding is available to support overarching coordination of trial sites both in Australia and overseas and to operate one or more clinical trial sites in Australia. Alternatively, where applicants are proposing to contribute to clinical trials initiated by the international collaborators, MRFF funding is available to coordinate Australian involvement and to conduct one or more clinical trial sites in Australia.

All clinical trial sites located overseas must be supported by the study’s international research collaborators or other sources of funding. Evidence of funding for overseas trial sites must be provided prior to commencement of MRFF funding.

Funding

Up to $42 million have been allocated for grants under the ICTC grant opportunity over four financial years. It is anticipated that up to $4.2 million will be available in each Peer Review Cycle; 1x in 2018, 3x each in 2019 – 2021 and 1x in 2022.

Up to two grants, each of up to five years duration, may be selected for funding in each Peer Review Cycle.

Eligibility

A CI can only be named on one application submitted for consideration at any one time. Applications will be considered for funding in the most recent and the two preceding Peer Review Cycles. Applications are only assessed once and will retain their overall score for the preceding cycles where they are included for consideration.

CIs who have submitted applications to the recent MRFF Clinical Trials Activity – Rare Cancers, Rare Diseases and Unmet Need (RCRDUN) grant opportunity are excluded from applying until the outcomes from the RCRDUN round are released.

How to Apply

  1. Submit a Notice of Intent (NOI)

    The NOI should be completed early to provide RIC with CIA contact details.

  2. Update RGMS Profile

    Each CI must obtain access to RGMS and update profile information (see RGMS information)

  3. Review documentation

    Review the ICTC grant guidelines and category descriptors available at Grant Connect GO1737.

  4. Complete the application

    Log in to RGMS and complete the application.

  5. Submit “Review Ready” application to RIC

    Submit application to RIC within the RIC internal submission period for review.

  6. Application review

    RIC staff members will review the application and provide the applicant with feedback via email.

  7. Complete application

    After taking feedback from the RIC team into consideration, complete the application in RGMS. It is suggested advice is sought from colleagues, Faculty Mentors, etc. before finalising the application.

  8. Submit the UoM Authority to Submit Form

    This form must be submitted to RIC electronically by the final internal closing date. This form should include:

    • Complete the compliance and eligibility section
    • Signature of all CIs and PIs
    • Signature of the Head of Department for each CI
    • Signature of the CEO (or delegate) for all PIs

    Electronic signatures are permitted.

    This is an NHMRC requirement and the application cannot be submitted to NHMRC until received.

  9. Final Submission

    On the final internal closing date, the applicant must:

  10. RIC will submit the application

Once the application has been submitted to NHMRC, you will receive an email from RIC confirming submission.

Supporting Documents

NHMRC Documents

RIC Documents