ELA International represents national ELA associations from different countries that contribute together to the financing of research on leukodystrophies. It is run by parents and /or patients affected by leukodystrophies. Accordingly, ELA International wishes to open a one-time funding opportunity for a program devoted to the conduction of a clinical trial in leukodystrophy.
The goal of the program is to support the clinical development of a therapy in leukodystrophies, the clinical development of products for use in leukodystrophies where no current therapy exists or where the product being developed will be superior to the existing therapy. ELA will provide a grant for a single clinical trial on safety and effectiveness that will either result in, or substantially contribute to, the validation of a therapy in leukodystrophies or market approval of these products. Applicants must include in the application an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
The purpose of this call for proposals is to encourage applications for investigator-initiated exploratory clinical trial to ELA International. The trials must address questions within the mission and research interests of ELA International and may evaluate drugs, biologics, and devices, as well as surgical, behavioral and rehabilitation therapies in leukodystrophy patients. Information about the mission and research interests of ELA International can be found at ELA International website.
The scientific merit of applications is determined by peer review. A Review Committee will recommend applications for funding based on the scientific merit, together with their judgment of the degree to which proposals are responsive to ELA's mission and research priorities and have potential for high impact.
Submission of a Letter of Intent (LOI) is required to apply for the 2019 ELA clinical trial FOA. To apply, simply:
Eligible projects, according to scientific merit scores, will then receive a detailed application form to be completed. Projects selected by the Review Committee will be notified by November 2019 and invited to submit a full application by February 2020.
NB: All clinical trial applications must obtain regulatory agency authorizations by January 1st, 2020.
It is critical that applicants read and follow all application instructions in the 2019 ELA clinical trial FOA Instructions and Policies (available HERE). Conformance to all requirements is required and strictly enforced. Applications that do not comply with these instructions may be delayed or not accepted for review.
Themes proposed in the 2019 ELA clinical trial FOA will focus on clinical trial in the field of leukodystrophies.
The trials should address a therapeutic gap in the field of leukodystrophies. Joint funding initiatives are encouraged.
Direct costs requested to ELA cannot exceed 500,000 € in total, with a three years-limit in funding period. Joint funding initiatives are encouraged.
For more information: firstname.lastname@example.org.