2020 ELA clinical trial
Funding Opportunity Announcement (FOA)
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 on a program devoted to the conduction of clinical trials in women with X-linked leukodystrophy.
Funding Opportunity Purpose
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’s Background and Significance section 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 http://elainternational.eu/en.
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 2020 ELA clinical trial FOA. To apply, simply:
To download the LOI application form HERE
Return the completed form by email no later than midnight CET Tuesday July 14th, 2020 and by post to ELA Research department no later than midnight CET Tuesday July 21st, 2020.
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 2020 and invited to submit a full application by February 2021.
NB: All clinical trial applications must obtain regulatory agency authorizations by January 1st, 2021.
Required Application Instructions
It is critical that applicants read and follow all application instructions in the 2020 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.
Letter of Intent submission deadline: July 14th, 2020
Themes proposed in the 2020 ELA clinical trial FOA will focus on clinical trial in the field of women with X-linked leukodystrophies.
Research Topic of Interest includes:
- Clinical trial for women with X-linked leukodystrophies
The trials should address a therapeutic gap in the field of leukodystrophies.
Funding Opportunity Description
Direct costs requested to ELA cannot exceed 500,000 € in total, with a two years-limit in funding period. Joint funding initiatives are encouraged.
In return for the grant allocated, the Applicants will be committed to use the platform Leuconnect for the conduct of their study, to make the Data collected within the framework of the Research freely available to ELA International and academic partners. Co-ownership of the patents and/or financial grant-back in case of valorization or exploitation of the Results shall be agreed upon between ELA International and the grantee.
For more information: firstname.lastname@example.org