BIH Lecture “Impact of Clinical Trial Data Sharing Policies”

Part of the Lecture Series “Frontiers in Translational Medicine – Scientific and Structural Challenges” on key questions of translation in medicine. Moderation: Prof. Dr. Ulrich Dirnagl (Founding Director of the QUEST Center for Responsible Research, BIH Chair and Head of research group)

In June 2021, the European University Hospital Alliance, of which Charité – Universitätsmedizin Berlin is a member, has signed the Sorbonne Declaration on Research Data Rights. This commitment to share medical research data, including clinical trial data, is in line with efforts of journals, amongst others. Florian Naudet will present an overview of actual data sharing practices, and show that despite efforts to make data available, journal policies are only poorly implemented, and data sharing is as yet far from being the norm.

Efficient sharing and re-use of data from clinical trials is expected to maximize the value of research for clinical practice. The International Committee of Medical Journal Editors (ICMJE) requires a data-sharing plan to be included in each paper from 1 July 2018 and pre-specified in study registration for clinical trials beginning enrollment of participants after 1 January 2019, as a condition for publication.

Although data-sharing plans help increase transparency, they do not ensure that data are shared, and they are often inadequately implemented. The ICMJE clinical trial data-sharing policy needs to be strengthened to ensure that clinical trial data is shared, as patients wish, and its value maximized.

About the Speaker

Prof. Florian Naudet

Florian Naudet is a psychiatrist, meta-researcher and former post-doctoral fellow at METRICS (the meta-research investigation center at Stanford). He’s currently teaching Therapeutics at Rennes 1 University, France. His research interests are evaluating and developing methodological solutions to assess treatments in patients, primarily but not exclusive in psychiatric research. He has a strong interest in studying research wastes and data sharing practices. He has worked in the fields of clinical pharmacology, research methodology, epidemiology, and neurosciences.

Further Information

http://www.reither.org/

https://metrics.stanford.edu/people/florian-naudet

Registration

The lecture will be held online via GoToMeeting. To participate in the lecture, please register here. The registration will be open until maximal participant capacity is reached.