Objectiu de la convocatòria

The aim of the E-Rare Joint Transnational Calls (JTCs) is to enable scientists in different countries to build an effective collaboration on a common interdisciplinary research project based on complementarities and sharing of expertise, with a clear translational research approach.

The specific objective of this call is to promote clinical and pre-clinical proof of concept studies for the potential application of medicinal products that are either already marketed or having achieved a significant stage in the development process in rare indications. Projects should aim at discovering new therapeutic uses for Agents whose clinical safety has already been documented to move quickly into proof of concept trials in the selected rare diseases' patient population.

Projects shall involve a group of rare diseases or a single rare disease following the European definition i.e. a disease affecting not more than five in 10.000 persons in the European Community, EC associated states and Canada.

Característiques principals

Two types of projects are eligible for this call:

Type A: Preclinical studies to verify target engagement and to perform additional toxicity testing if necessary (for example in the case of paediatric indications where juvenile animal studies might be warranted) in a disease model for a maximum period of one year followed by the implementation of Phase 1b or Phase 2a clinical trials at the beginning of the second year of the project. For this call, Phase 1b, and Phase 2a trials are defined as follows: Phase 1b trials are defined as studies usually conducted in the target patient population to establish feasibility (e.g., target engagement, pharmacodynamics/pharmacokinetics (PD/PK), initial dosing of the Agent) prior to a Phase 2a trial. Phase 2a clinical trials provide data on the relationship of dosing and response for the particular intended use (including trials on the impact of dose ranging on safety, biomarkers, and proof of concept).

Type B: Milestone-driven Phase 2 clinical trials to demonstrate that the Agent modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population for a period up to three years.

Convocatòria (URL)

http://erare.eu/joint-call/e-rare-3-call-proposals-2016-jtc-2016-clinical-research-new-therapeutic-uses-already-0

Requisits

Only transnational projects will be funded. Each consortium submitting a proposal must involve a minimum of three eligible and a maximum of six eligible partners from at least three different countries participating to the call (see list above). No more than two eligible partners from the same country participating in the call will be accepted in one consortium.

Applicants are encouraged to include partners from the participating Eastern European countries (Hungary, Latvia, Poland and Turkey). If they include such partners, the maximum number of eligible partners can be increased to eight (see table below).

Additional partners that secure their own funding may join consortia. However, their number is limited to two. The consortium coordinator must always be eligible to receive funding from the funding organisations participating in the call.

Whilst applications will be submitted jointly by groups from several countries, individual groups will be funded by the individual E-Rare-3 funding organisation respective of the country from which applicants have applied. The applications are therefore subjected to eligibility criteria of individual funding organisations.

For Spanish applicants: please check the eligibility requirements of the institution and the principal investigator/team members, in pages 32-33 of the Guidelines.

Applicants are strongly advised to contact their national representative and confirm eligibility with their respective funding organisations in advance of submitting an application

Documentació

There will be a pre-registration procedure followed by a two-stage submission/evaluation procedure for joint applications.

Indicative for pre-registration: February 1, 2016

Indicative for submitting the full proposals: March 3, 2016

Communication of selection of pre-proposals: June, 2016

Date of submission deadline for joint rebuttal / modified proposals: July 18, 2016

Dotació

The funding depends on national/regional rules. For Spanish entities, up to € 150,000 for coordinators and € 100,000 for partners.

Durada

3 years

In case of interest please contact the Support Research Office (Leonor Norton lnorton@fsjd.org , recerca@fsjd.org).