Clinical trials – could hardening attitudes towards data privacy and new big data rules impede effective drug development?

Andrew Rut, chief executive of MyMeds&Me, a provider of adverse event and product quality capture software, considers in an Expert View piece how pharma’s ability to run efficient clinical trials is in danger of being compromised by the European Union's General Data Protection Regulation (GDPR) and a hardening of attitudes on data privacy globally.

Data privacy has emerged as one of the most evocative issues of our time. Global attitudes towards the protection and ownership of personal data are hardening. This is being reflected in public policy: for instance, GDPR, set to come into force in May 2018, expands existing rules in areas such as patient consent, and imposes tough penalties for non-compliance.

It is essential for pharma companies to ensure the privacy of the data they collect and store on patients who participate in their trials or on patients who notify them of safety issues. However, parts of measures such as GDPR could have unintended consequences and hinder their ability to run efficient clinical trials. This piece discusses the big data landscape, and looks at where conflicts could arise between hardening attitudes towards privacy and the needs of clinical trials to operate effectively.