The European Rare Diseases Research Alliance (ERDERA) has launched its Clinical Trial Call 2026 to support multinational, GCP-compliant early-phase interventional clinical trials in rare diseases.
The call aims to generate robust clinical evidence and, where appropriate, data of regulatory relevance to support future regulatory interactions and subsequent clinical development. It addresses a key challenge in rare disease research: patient populations are often small and geographically dispersed, making multinational collaboration essential for the successful implementation of clinical trials.
The call supports Phase I, Phase I/II and Phase II interventional clinical trials. Eligible interventions include small molecules, including repurposed drugs, advanced therapy medicinal products, biologics and repurposed biologics. Priority areas include paediatric rare diseases, rapidly progressive rare diseases, and rare diseases with no approved therapeutic options or substantial remaining unmet medical need despite existing treatments.
- The application process starts with a mandatory Stage 0 Expression of Interest, open from 1 July to 10 September 2026.
- Stage 1 Short Proposals can be submitted from 15 September to 29 October 2026.
- A structured support phase, Stage 2, will follow for selected applicants, covering regulatory, methodological and patient and public involvement and engagement aspects, before invited full proposals are submitted in Stage 3.
An information webinar will take place on 6 July 2026, from 15:00 to 17:00 CEST.