The use of the EUDAT repository to store clinical trials in a secure and compliant way Wolfgang Kuchinke Heinrich-Heine University Düsseldorf Germany. duesseldorf.de

Your Current Challenges Challenges – Gap in the translation of basic scientific discoveries into clinical trials and medical practice – Clinical trials are too inefficient – Clinical source data not available for independent, secondary analysis and meta-analysis Potential consequences without a solution – Continuing existence of isolated and inaccessible silos and archives with clinical trials data – Clinical trials are not being optimised, have to be terminated prematurely, are redundant

Why EUDAT? Interest in EUDAT services – A generic approach is needed to open clinical trials data for the research environment by using an EUDAT repository for clinical trials source data – Build on the experiences of EUDAT and other research groups, use common standards and tools Benefits of using EUDAT services – Integrate trials data and metadata into the generic EUDAT service layer, collaborate with all kind of research areas (e.g. climate, environment) – Becoming part of such a large and trusted infrastructure – Encourage clinical researchers to provide their trials data

Position of the clinical trial data repository in the clinical trials workflow

The expected future impact Interest to other communities – Pilot outcome is of great interest for all involved in research with human health data – New methods for analysis and meta-analysis, including trials that were not properly finished or published – Compare restricted access clinical data with open access data available in a multitude of databases How can EUDAT further support? – Include usability evaluation – Consider differential data and privacy protection – Develop a service for distributed analysis