European Rare Diseases Research Alliance (ERDERA) Clinical Trial Call 2026

European Rare Diseases Research Alliance (ERDERA) Clinical Trial Call 2026 is sponsored by National Institute for Health and Care Research (NIHR). NIHR is participating in the forthcoming ERDERA Clinical Trial Call 2026.

Clinical Trial Call - ERDERA ERDERA has launched its Clinical Trial Call (ECTC) to support multinational, GCP‑compliant early‑phase interventional clinical trials in rare diseases. 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. 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.

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. ERDERA Clinical Trial Call – Call Text Call text draft setting out rules, eligibility and staged application process for the ERDERA Clinical Trial Call 2026.

ERDERA Clinical Trial Call 2026 – Pre-announcement Pre-announcement describing scope, eligibility and indicative timeline for the ERDERA Clinical Trial Call 2026, expected to open on 1 July 2026. ERDERA Clinical Trial Call – Guidelines for Applicants These guidelines explain the eligibility rules, submission process and Expression of Interest requirements for the ERDERA Clinical Trial Call. ERDERA Clinical Trial Call – Annex IV.

Guidelines for Canadian Applicants This annex explains the specific eligibility, sponsorship, funding and application requirements for Canadian applicants in the ERDERA Clinical Trial Call. ERDERA Clinical Trial Call – Expression of Interest template This template lists the sections and fields applicants must complete for an Expression of Interest in the ERDERA Clinical Trial Call.

Example of costing of Clinical Trial Budget Budget example showing low and high cost ranges for a Phase 1 rare disease clinical trial with twenty subjects. 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 .

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.

Link to submission platform You might also be interested in ERDERA launches Clinical Trial Call 2026 to advance early‑phase clinical trials for rare diseases ERDERA (the European Rare Diseases Research Alliance) has opened its Clinical Trial Call to support multinational early-phase clinical trials in rare diseases.

The call will fund studies designed to generate robust clinical evidence, strengthen regulatory readiness and make rare disease trials more feasible across countries. ERDERA Clinical Trial Call – Call Text Call text draft setting out rules, eligibility and staged application process for the ERDERA Clinical Trial Call 2026.

ERDERA Clinical Trial Call – Information Webinar July 6 @ 3:00 pm - 5:00 pm ERDERA Clinical Trial Call: pre‑announcement and key dates ERDERA will launch its Clinical Trial Call (ECTC) on 1 July 2026, supporting multinational, GCP‑compliant early‑phase interventional clinical trials in rare diseases. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nunc purus nibh, fermentum id blandit in, tempor nec justo.

Maecenas vehicula metus est, ut dapibus ipsum faucibus vitae. The gene therapy pipeline is intransigently linked to vector efficacy. Due to a paucity of vectors capable of harboring large expression cassettes, several rare diseases have little hope of being targets The gene therapy pipeline is intransigently linked to vector efficacy.

Due to a paucity of vectors capable of harboring large expression cassettes, several rare diseases have little hope of being targets