A lot has happened since our last edition of RA Watch in March. Nobody could have imagined how the COVID-19 pandemic would dominate the work of thousands of researchers and regulators and spark an unprecedented global effort (see the Headlines and Happenings section).
Not only regulatory processes but also the way in which human research finds solutions to treat or prevent diseases have been shaken, with politics and egos sometimes interfering too much. At times, this has led to situations where good and evil coexist. On the one hand, we have been shocked by Russia’s and China’s declarations to use a vaccine early, with large numbers of their citizens essentially being asked to serve as test subjects as an act of patriotism. One the other hand, we have welcomed the joint efforts of global and regional regulatory organisations and the intensification of international cooperation: calls for larger studies, increased transparency, guidelines for diagnostic devices, treatment and vaccine developments – including end points to consider, increased use of observational studies, and more reflection on regulatory flexibility (e.g. early scientific advice and fast-track authorisation).
Since March, Switzerland has been hurrying – or should we say racing – to start numerous clinical studies and registries on COVID-19. Funding for such projects has been made available. And the regulatory action taken to get projects authorised rapidly has been tremendous. Switzerland’s ethics committees and Swissmedic have focused on authorisations and thus been able to approve projects within a couple of days. In addition, guidance on how to manage clinical studies in such situations was provided in April. However, the coordination needed to select and run ambitious research projects was initially missing, which has been problematic when the number of patients available to enroll decreases. To date (28 September 2020), 260 clinical trials and research projects on COVID-19 have been approved in Switzerland – 43 of which are multicentric (source: swissethics).
How will Switzerland contribute to research findings compared to other countries? Will Switzerland get there slowly but surely? Might this pandemic lead to new opportunities to ease regulatory processes while still ensuring patients’ safety? The time will soon come to reflect on and share lessons learnt from this period.
Medical registries: Unlocking their full potential in Switzerland
In each issue of RA Watch, we focus on a specific topic related to human research – in this issue we have chosen to look at medical registries (MRs). Even if MRs have long been underestimated as a research tool, there is a clear upward trend in the proportion of research projects linked to them (see Medical registries in Switzerland). The COVID-19 pandemic has reinforced this trend through the analysis of exceptional clinical routine data.
How are MRs regulated in Switzerland? What recommendations exist for them? What support for registries is currently available or being developed, and what is still missing? What are the key aspects to consider for their success? We address these questions in the News From and Deep Dive sections. We also use specific registries as illustrations: one initiated by a foundation for implantation medicine (SIRIS) and one initiated by a patient association (Swiss MS Registry). This issue of RA Watch also contains an example of successful registry governance at a university hospital (CHUV). In addition, we share the results of a national survey on electronic health record (EHR) systems that was conducted by the SCTO’s Regulatory Affairs Platform.
We hope you enjoy reading this issue of RA Watch and it helps you become more familiar with a promising research tool!
Séverine Méance, RA Watch Editor
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