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.
Eligible applicants include 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), Advanced Therapy Medicinal Products (with GMP‑validated manufacturing appropriate for Phase I/II), biologics/new biological entities, and repurposed biologics.
Application process and support
- Information webinar: 6 July 2026, 15:00–17:00 CEST. More information and registration.
- Stage 0 – EOI (mandatory): 1 July – 10 September 2026.
- Stage 1 – Short Proposal: 15 September – 29 October 2026.
