Clinical Trial Call

Organisme : ERDERA
Programme : Clinical Trial Call
Financement : 1 à 5 M$ 
Durée : 24 à 36 mois

Description 

The aim of the ERDERA Clinical Trial Call (ECTC) is to fund multi-national, sponsor-led, GCP compliant Phase I/II interventional clinical trials on rare diseases, generating data of sufficient quality and regulatory relevance to support future EMA regulatory filings, where appropriate. The call specifically targets areas of high unmet medical need where centrally coordinated; multinational funding offers a decisive advantage over individual national efforts.

Study proposals must meet all of the following criteria:

• Address a rare disease within the meaning of Regulation (EC) No 141/2000 on orphan medicinal products-defined as a condition affecting not more than five in 10,000 persons in the European Community-as classified by Orphanet.
• Address a clearly defined, high unmet medical need in a severe, debilitating, or life threatening condition in the relevant patient population.
• Target diseases with no satisfactory or sufficiently effective therapeutic option currently available, or with substantial residual unmet need despite existing treatment.
• Consists of multi-national Phase I, Phase I/II, or Phase II interventional clinical trials conducted in accordance with Good Clinical Practice (GCP) as per ICH E6(R3) guidelines and applicable EU regulations (EU Clinical Trial Regulation No. 536/2014).

Priority areas for this call:

While proposals on all eligible rare diseases are welcome, the call particularly encourages applications addressing the following disease categories, where the need for coordinated multinational funding is most acute:

• Paediatric rare diseases - conditions in which the relevant patient population is predominantly paediatric, as classified by Orphanet
• Rapidly progressive rare diseases - conditions characterised by swift clinical deterioration over a short timeframe, creating heightened urgency for access to investigational therapies
• Conditions lacking approved therapeutic options - rare diseases for which no medicinal product has received marketing authorisation in the EU, or for which existing authorised treatments provide only partial or insufficient clinical benefit

These priority areas are not eligibility criteria. However, where two or more proposals are of otherwise equivalent scientific quality, alignment with the above priority areas will be taken into account in the final strategic prioritisation.

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