Rebecca Sudlow, Janice Branson, Katherine Tucker.
This session covers the essential principles that statisticians need to be aware of regarding clinical data and patient privacy (e.g. GDPR) and how data can be re-used responsibly. What has changed? Why is data now an asset? Over the last decade we have seen a massive change with regard to data transparency from clinical trials - increase in sharing through CT.gov, EUDraCT as well as many companies and institutions actually allowing access to individual level patient data upon request from researchers. More recently EMA and other Health Authorities have rolled out policies to make documents such as anonymised clinical study reports publicly available. Within Pharma companies we see many initiatives to try to make better use of the wealth of data the companies have and even initiatives to leverage data across companies and from health records in an attempt to have smarter, shorter and more ethical drug development programs. This is all needs to be done taking into account new legal requirements coming from GDPR for example as well as working in the framework of informed consent or anomymizing the data or even exploring newer areas like synthetic data.