Drug and Device Clinical Trials and the GDPR

Twelve Months on, What Are the Implications of the GDPR on Drug and Device Clinical Trials?

Clinical trials are a critical and fundamental part of all life science companies’ operations. Data management, security, and privacy within clinical trials are important, but they're complicated.

They're complicated because of:

  • the number of parties who provide, handle and process data including “personally identifiable information”.
  • the increasing use of the internet, electronic records, and the advancement of clinical trial technologies that enable the collection and use of data.
  • the increasing importance of “big data” in clinical research.

In this article Marsh Asia’s Life Sciences Industry Leader, Prashansa Daga, discusses the implications of the changing regulatory landscape for all players within the clinical trial supply chain.

In particular, what is the role of the European Union’s (EU) General Data Protection Regulation (GDPR) with respect to clinical trials data, and what are the responsibilities and obligations on healthcare professionals and companies using individuals’ data?

Working through a number of clinical trial scenarios and whether the GDPR may or may not apply, this piece finishes with a discussion of:

  • Risk considerations.
  • Actions insurance buyers can take.
  • Some recommendations about what areas clinical trial supply chain players can work on with their advisers.