The use of the EUDAT repository to store clinical trials in a secure and compliant way

1. Wolfgang Kuchinke Heinrich-HeineUniversity Düsseldorf Germany. wolfgang.kuchinke@med.uni-duesseldorf.de The use of the EUDAT repository to store clinical trials in a secure and compliant way

2. 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

3. 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

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

5. 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