RealiseD - Comprehensive methodological and operational approach to clinical trials in rare and ultra-rare diseases
Department of Medical Statistics
This project focuses on identifying and solving challenges related to evidence generation in small populations and is expected to support medicinal product development for rare and ultra-rare diseases.
RealiseD will implement a collaborative and comprehensive methodological approach for clinical trials in (ultra-)rare diseases, enabling faster therapeutic development, balancing the need for timely development and regulatory compliance and HTA assessment with the evidence level realistically attainable in a constrained environment.
To reach this goal, RealiseD consists of highly committed and experienced experts from patient organisations, academia, industry, regulators, HTA, and policy makers, combining clinical, methodological, and regulatory expertise.
Involved scientists from the Department of Medical Statistics
Prof. Tim Friede
Head of the Department of Medical Statistics