| Característica |
Objectiu de la convocatòria
This call supports multinational, GCP-compliant Phase I, Phase I/II and Phase II interventional clinical trials in rare diseases, aiming to generate robust clinical evidence and, where appropriate, regulatory-relevant data to support future regulatory interactions and subsequent clinical development.
|
Característiques principals
Proposals must address rare diseases as classified by Orphanet, with a clearly defined high unmet medical need and no satisfactory therapeutic option or substantial residual unmet need despite existing treatments.
Priority areas include paediatric rare diseases, rapidly progressive rare diseases, and rare diseases with no approved therapeutic options or insufficient current treatments.
Eligible interventions include small molecules, including repurposed drugs; ATMPs with GMP-validated manufacturing appropriate for Phase I/II; biologics and new biological entities; and repurposed biologics.
|
Lloc de presentació
HMRIB and PSMAR staff who need further information should contact the Research Grants and Contracts Office:
C/ Doctor Aiguader, 88, 08003 Barcelona | Tel. 933 160 400
Carol Barnwell: [email protected], Ext. 1670
Marta López: [email protected], Ext. 1576
Júlia Vidal: [email protected], Ext. 1736
|
Convocatòria (URL)
https://erdera.org/call/ctc2026/
|
Informació addicional
This call follows a multi-stage process: a mandatory, non-competitive Stage 0 Expression of Interest (EOI), followed by a Stage 1 Short Proposal, a structured Stage 2 Support Phase covering regulatory, methodological and PPIE support, and an invited Stage 3 Full Proposal.
Stage 0 – EOI: 1 July – 10 September 2026
Stage 1 – Short Proposal: 15 September – 29 October 2026
An information webinar will take place on 6 July 2026, from 15:00 to 17:00. Registration is available at: https://erdera.org/event/erdera-clinical-trial-call-2026-information-webinar/
|
Requisits
Eligible organisations include universities, higher education institutions and research institutes; hospitals, clinical research organisations and other healthcare settings; non-profit research organisations and foundations; Patient Advocacy Organisations (PAOs); and SMEs.
Consortia must include at least three independent eligible-for-funding partner institutions from at least three different ERDERA member countries. PAOs focused primarily on PPIE activities do not count towards this minimum, unless they act as the Clinical Trial Sponsor and meet the Sponsor eligibility and capacity requirements.
Each consortium must designate a Clinical Trial Sponsor and a Coordinating Investigator, include at least one funded patient partner through a PAO or other organised patient group, and either include or demonstrate formal access to a qualified multinational Clinical Trial Management Organisation (CTMO).
|
Dotació
€1–5 million per project; budgets outside this range may be eligible if duly justified.
|
Durada
Initial trial execution is expected to last approximately 2–3 years, with possible continuation funding for an additional 2–3 years subject to predefined Go/No-Go criteria. The total duration may not exceed 7 years.
|
Documentació
EOIs must be submitted online through the Fondazione Telethon Grant Management system. Guidelines/templates for short and full proposals will be published in due course.
|