Since the first PHUSE Data Transparency Event in 2020, PHUSE have continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked and challenges addressed.
The PHUSE Data Transparency Winter Event 2022 took place 8–10 February and welcomed 500+ registered attendees, with over 300 joining live each day. The event’s agenda was dedicated to EU CTR, Anonymisation, Plain Language Summaries and Data Sharing. Take a look below for further detail on the topics covered each day.
We look forward to seeing you at the Summer Event in June!
Event Presenters
Day 1 – EU CTR
Day 1 of the event focused on the European Union Clinical Trials Regulation (EU CTR), which came into force on 31 January 2022, with go live of the new clinical trials information system. There were four presentations: three from industry representatives and one from Dr Noémie Manent of the European Medicines Agency.
The talks focused on the transparency aspects of the Regulation, including the scope of documents to be published, the types of information to be protected by redaction of content or deferral of publication, and the process and resource implications for EU trial sponsors. Dr Manent discussed the principles of publication deferral in more detail and indicated in the Q&A session that sponsors will be expected to approach deferral justification in a consistent manner and can expect to liaise closely with Member States on deferral and redaction. Additional guidance on management of personal protected data and confidential commercial information under the EU CTR is expected to be available by the end of Q1 2022.
Day 2 – Anonymisation
Day 2 focused on anonymisation and featured an update from Health Canada on the Public Release of Clinical Information (PRCI) after three years of the initiative. Attendees heard considerations for DICOM image anonymisation as well as an approach to document anonymisation using a quantitative approach when no underlying data exists.
We also had an overview and status update of PHUSE’s Good Transparency Practices Project from the Project Lead, Lauren Hepburn, Privacy Analytics.
Day 3 – Plain Language Summaries and Data Sharing
The final day of the event was split into two parts. Part 1 focused on plain language summaries, including a panel discussion where attendees heard practical lessons learnt from four experts on preparing for plain language summaries and explored regulatory requirements related to PLS.
Part 2 took a deep dive into data sharing. Bioethical considerations were explored, as well as insight into how a transformational data sharing program allows data to be discoverable and how anonymisation enables additional research and advanced analytics. We also heard an overview of a new multi-stakeholder consortium that serves the clinical data-sharing ecosystem.
Watch On Demand
If you missed the event, or would like to watch your favourite presentation again, you can do so now on the PHUSE Engagement Hub. Recordings and presentations from each day are now available for on-demand viewing.
Thank You
As always, PHUSE would like to give a big thank you to all involved in making this event another successful one – especially to our sponsors, who this work would not be possible without.
