ERDERA has opened its Clinical Trial Call (ECTC) to support multinational, GCP‑compliant Phase I, Phase I/II and Phase II interventional clinical trials in rare diseases.
This call aims to generate robust clinical evidence and, where appropriate, data of regulatory relevance to support future regulatory interactions and subsequent clinical development. It is designed for rare disease trials where patient populations are often small and geographically dispersed, making multinational collaboration essential.
Priority areas (not eligibility criteria): paediatric rare diseases; rapidly progressive rare diseases; and rare diseases with no approved therapeutic options or with substantial residual unmet medical need despite existing treatments.
Who can apply
Universities/research institutes, hospitals/clinical centres, non‑profit research organisations and foundations, Patient Advocacy Organisations (PAOs), and SMEs (subject to specific funding provisions). Each consortium must designate a Clinical Trial Sponsor and a Coordinating Investigator, include at least one funded patient partner (via a PAO or other organised patient group), and secure access to a qualified multinational Clinical Trial Management Organisation (CTMO).
Only multinational trials will be funded (minimum of three independent eligible partner institutions from at least three different eligible countries; PAOs focused primarily on PPIE do not count towards this minimum).
Eligible interventions include small molecules (including repurposed drugs), ATMPs (with GMP‑validated manufacturing appropriate for Phase I/II), biologics/new biological entities, and repurposed biologics.
How it works
A multi‑stage process with a mandatory Stage 0 Expression of Interest (EOI) followed by Stage 1 Short Proposal, a structured Stage 2 Support Phase (regulatory, methodological and PPIE support), and invited Stage 3 Full Proposal.
- Information webinar: 6 July 2026, 15:00–17:00 CEST. More information and registration here.
- Stage 0 – EOI (mandatory): 1 July – 10 September 2026.
- Stage 1 – Short Proposal: 15 September – 29 October 2026.
Call Documents
Important notice: this pre‑announcement and draft documentation are provided for information purposes only and are non‑binding and subject to change. Only the official Call Text and application documents published at call launch will be authoritative.
For scientific queries, contact the Clinical Trial Call Scientific Secretariat: ctc.secretariat@erdera.org.
Submission Platform
Please note: the submission platform is managed by Fondazione Telethon, ERDERA’s central funding administrator for this call, so by clicking the link below you will leave the erdera.org environment.
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