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International Clinical Trials
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The European clinical research industry is in a period of great
uncertainty. As it reckons with current trends – such as a decline in
favourability as a clinical trial destination in favour of the Asia
Pacific (APAC) region and other geographies – it is simultaneously
bracing itself for other changes on the horizon. These upcoming changes
are largely regulatory in nature; new regulations are related to
advanced therapy medicinal products (ATMPs) and medical devices, which
could both add and relieve headaches for researchers (1). Also, the new
Clinical Trial Regulation is coming in 2019. Furthermore, after Brexit
takes effect that same year, the UK may exempt itself from the
Regulation, possibly creating complexities and uncertainties both there
and in the post-Brexit EU (2).
Then there is the Greater Data
Protection Regulation (GDPR): a vast set of rules and guidelines aimed
largely at securing the personal data of EU citizens stored and
processed online. While designed for the protection of Europeans, the
effects of the GDPR are by no means limited to Europe: EU nationals
anywhere in the world are protected by the new law – the personal data
of a German citizen living and working in Australia, for example, would
be covered – lending it significance on a global level. Given its
breadth and its imminence (the law is set to take effect in May of this
year), it behooves one to examine the context from which it emerged, as
well as how the clinical research industry falls within its scope.
Indeed, clinical research and the healthcare industry, at large – which
stores massive quantities of personal data in formats such as electronic
medical records and clinical trial databases – is bracing for the
impact of the GDPR on its operations. What events set the stage for the
GDPR, how will it affect Europe’s status as a clinical trial
destination, and how can organisations ensure compliance?
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