GDPR—not just an EU regulation?

November 15 17:06 2019 Print This Article

The wave of concern regarding the recent EU General Data Protection Regulation (GDPR) enforcement has firmly reached Australia. These far-reaching regulations return personal data ownership and control completely back to the individual, ostensibly even for data previously covered by consent to participate in a clinical trial. As noted by Anastassia Negrouk and Denis Lacombe in The Lancet Oncology,1 the guidance and practical responses to GDPR have been inconsistent, suboptimal, and unsettling.Most pressing is clarity around GDPR compliance requirements within active clinical trials that involve EU participants. Having recently been involved in an Australian-led prostate cancer trial involving broad collaboration with EU sites (NCT02446444),1 which is likely to be in follow-up for several years yet, rumours of stop-gap measures of GDPR compliance to date are unnerving. Actions as seemingly innocuous as annual reconsenting of all participants would be logistically and financially crippling to many studies, and unanticipated participant dropouts in reaction to more onerous information feedback and consent requirements could impact study power. Furthermore, redesign of data storage to provide unfettered participant access is not a trivial undertaking for trial management centres.A further concerning interpretation of GDPR is that initial consent explicitly only covers the primary trial endpoint, with all secondary analyses requiring individual specific consent. As such, the concept of so-called future unspecified research might now be stripped from our academic arsenal. Unspecified future studies of clinical outcomes can be highly valuable—for example, in the complex task of identifying a surrogate endpoint for survival in prostate cancer, which was greatly aided by EU data.2 For biological research, large banks of tissue and blood samples are now gathered as a routine in contemporary trials to support potential molecular analyses. How we handle these eventualities needs to be clearly articulated to trial participants, EU researchers, and their collaborators.Our EU collaborators are crucial in ensuring the successful completion of large and important global clinical questions. However, we are in an era in which extreme financial risk aversion reigns supreme, and undoubtedly trial groups or industry running studies involving EU participants will have to re-evaluate their involvement. It is doubtful that any academic would be averse to improving the experience of participants in clinical trials, but it would be disappointing to see such an individual-centric initiative interfere with the role of our EU colleagues in the global community. We look forward to compliance guidelines that are pertinent, unambiguous, and, most of all, expeditious.

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Scott Williams
Scott Williams

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