Request for Applications: Clinical Trial Grant Program

Donor Name: FightMND

Reference URL:https://fightmnd.org.au/our-work/our-grants/

The Clinical Trial Grant Program has announced its research grants to support academic-industry partnerships and MND researchers developing Phase II or III clinical trials of novel treatments to advance translational research into motor neurone disease.

Proposals must be for one Phase II or Phase III clinical treatment trial of a novel drug or drug combination, device, or management practice for MND. Trials should generate high-quality data that could lead to efficacy or Phase III trials. Phase II studies may be proof-of-concept trials designed to establish safety in the target MND population and explore the relationship between dose and desired activity; randomised placebo-controlled Phase II trials are welcome.

Proposed treatments must include a pharmacodynamic marker to measure whether the target pathway has been affected, a plan to collect samples for biomarker studies, and promising efficacy in at least two MND disease models. For proposals targeting sporadic MND, one model must represent human sporadic MND.

Up to AUD $1,800,000 in support from FightMND is available per grant for projects up to three (3) years. Applicants may request the full amount or a smaller amount suited to the proposed study. Institutional indirect costs, overheads and oncosts are not funded; itemised salary oncosts are acceptable. Capital equipment, equipment depreciation and equipment maintenance are not funded. Shared-funding proposals involving industry partners are strongly encouraged.

Projects must be deliverable within three years and include at least one Australian trial site; studies conducted entirely overseas are ineligible. Applications are invited from research-based institutions in Australia and internationally, including pharmaceutical and biotechnology companies, academic institutions and universities, hospitals, and MND researchers.

Investigators at all academic levels may apply, and applicants must demonstrate an established or developing record of research impact and output in MND or related research. MND experience is not essential, although collaboration with people with substantial MND research or model-system expertise is encouraged. FightMND does not restrict the Principal Investigator’s nationality; investigators based outside Australia are encouraged to collaborate with Australian-based co-investigators. Projects must demonstrate a collaborative approach.

Applicants should contact FightMND before submitting to discuss the budget, as trial logistics and infrastructure support may be available through an approved Contract Research Organisation. Support may include Australian clinical sites, project and grants management, biomarker and biobanking services, site start-up and monitoring, data management, biostatistics, medical monitoring, regulatory assistance, medical writing, and Good Clinical Practice training.

For more information, visit FightMND.

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