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EJP RD internal call for proposals - Clinical Trials Methodology Demonstration Projects

The Clinical Trials Methodology Demonstration Projects Call of the international consortium EJPRD - European Joint Programme on Rare Diseases is now open for submission of the 1-pager letters of interest.

AIM OF THE CALL

The call for demonstration projects aims to show the usability and capability of the innovative statistical methodologies for clinical trials in rare diseases, which have not been demonstrated on existing data for specific rare disease clinical trials yet. Necessary for a successful demonstration project is the collection of sufficient data from a rare disease clinical trial and related information to enable demonstration of the practicability, performance and opportunities of the innovative methodologies applied to these already acquired data. Trials are often performed with standard classical methodologies not specific for rare diseases resulting in a loss of power to show positive effects. The demonstration projects should use one of the following nine innovative statistical methodologies

1. Uncertainty evaluation (bias assessment)

2. Primary outcome variable (surrogate)

3. Primary outcome variable (co-primary)

4. Use of external information (historical control)

5. Use of external information (extrapolation)

6. Use of external information (dose response profiles)

7. Use of external information (single arm trials –threshold crossing)

8. n-of-1 trials

9. Rigorous use of longitudinal information, linked to an existing clinical trials dataset for a specific rare disease.

Please note that this call is open for teams from institutions that are beneficiaries of the EJP RD project only.

SUBMISSION OF PROPOSAL

The submission of proposal will follow two-phase process.

Phase 1:

After the official opening of the call on the 1^st of February 2020, the proposers possessing suitable data sets will be asked to submit only 1-pager (template will be provided) by 5 PM Central European Time (CET) on the 15^th of March 2020 to the Call Secretariat at: demonstration.callsec@ejprarediseases.org.

This stage will serve ONLY to review available data and ideas, and subsequently propose matching experts in methodology. It is not necessary to identify your methodologists in advance of this stage!

Phase 2:

The applicants withmatching methodologists will be asked to submit full proposals.

FUNDING MODEL

This call is internal and thus open to the partners of the EJP RD only. The funding model of the EJP RD applies, that is all projects will be co-funded up to 70%and the remaining 30% should be covered by the (in-kind) contribution of partners participating in the project. The EC contribution to demonstration projects will be up to 220,000€ per project excluding indirect costs. Thus, in case if the maximum funding of 220 000 € is requested, the total cost of the project (eligible direct costs, including in kind contribution) should be of at least 315 000 €. The financial reporting of the projects will be part of the general annual EJP RD reporting of respective partners.

Predsedníctvo SAV svojím uznesením č. 914 schválilo zapojenie tímov zo SAV do tejto výzvy a odsúhlasilo podporu projektov v trvaní do 24 mesiacov. Štruktúra rozpočtu pre partnerov zo SAV sa riadi všeobecnými pravidlami uvedenými v Call Texte, t.. j.

70 % nákladov bude hradených z prostriedkov pridelených na tento účel konzorciom EJP RD Úradu SAV

a 30% pokryje príslušná organizácia SAV

Viac informácií v prílohe alebo na stránke https://www.ejprarediseases.org/index.php/clinical-trials-met-dem-projects-call/

Všetci uchádzači musia pred podaním konzultovať svoju prihlášku s Odborom medzinárodnej spolupráce Úradu SAV.

Kontaktná osoba: Zuzana Černáková, +421 2 57510118, cernakova@up.upsav.sk