Clinical Forum for Operational Excellence

Data sharing is a topic which was originally kicked off by the EMA announcement that in future clinical study reports and individual patient data would be released to the public for every submission to ensure full transparency. This initiative triggered an intensive discussion globally. Pharmaceutical companies agreed to provide individual patient level data by themselves to independent researchers. There are significant consequences for the pharmaceutical industry. This concerns their dialogue with physicians, the way clinical study reports will be written, clinical studies designed, what kind of data to be sampled within a trial and last but not least also how patient confidentiality could be protected. It is important to have an overview on all these aspects when conducting studies in the future. This session should provide an overview where we are today as well as on potential consequences.