6th CEN Conference

[25] Realise D: compRehensive mEthodological and operational Approach to cLinical trIalS in ultra-rarE Diseases

19 May 2026, 10:00

7h 15m

x Poster display area

poster Poster session

Speaker

Christoph Gerlinger (Bayer AG, Clinical Statistics and Analytics, Berlin and Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland)

Description

Realise D is a public-private partnership of almost 40 partners from academia, regulatory bodies, clinical research institutes and hospitals, patient organizations, pharmaceutical companies, methodologists, and European Research Infrastructures. Realise D is part of the European Union’s Innovative Health Initiative and funded jointly by the EU and industry. The project started officially in January last year and will run for five years.

RealiseD is based on clinical use cases emerging from four European Reference Networks underlining the need for new innovative methodologies, especially in ultra-rare diseases.
We will present an overview of the RealiseD project with a clear focus on the work packages “Innovative clinical trial designs” and “Innovative analysis and data use strategies”. Both include strategies to include the use of external information to improve decision making in trials of ultra rare diseases.

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