UPDATE - Clinical Trials Methodology Demonstration Projects
UPDATE - Due to the COVID-19 outbreak the call deadline has been postponed to 31 March 2020.
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 1st 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 15th 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.
SAS Presidium by its decision no. 914 approved the participation of SAS research teams in this call and agreed to support successful projects with duration up to 24 months. Budget structure for SAS participants should follow the general instructions in the Call text, i.e.
70 % of the costs will be provided to the Slovak partner from resources allocated to this purpose by the European Commission via EJP RD consortium and via the Office of the Slovak Academy of Sciences
30 % must be an in-kind contribution of the SAS institute.
More information can be found in the attachment or at https://www.ejprarediseases.org/index.php/clinical-trials-met-dem-projects-call/
All applicants must consult their applications with the Department of International Cooperation of the Office of the Slovak Academy of Sciences before submission.
Contact person: Zuzana Černáková, +421 2 57510118, cernakova@up.upsav.sk