Since its inception in 2020, PHUSE’s Data Transparency Event has gone from strength to strength as the world’s largest home for data transparency events and the only free-to-attend conference in the field this summer. Here, we share essential knowledge of the field and create an open space where questions can be asked and challenges addressed.
This is our fifth Data Transparency Event and we are pleased to have created such a successful event that shares vital knowledge, advice and suggestions across all pharma companies (big and small), vendors and software companies in a way that isn’t cost-prohibitive.
The PHUSE Data Transparency Summer Event 2022 took place 28–30 June and welcomed 300+ registered attendees. The event agenda was dedicated to updates from companies navigating the European Union Clinical Trials Regulation (EU CTR), which came into force in January this year, as well as anonymisation, patient engagement and data sharing.
Each presentation section was followed by a joint panel discussion/Q&A to further explore the latest developments in this fast-paced area of clinical development. Our event attendees were very engaged in the topics – we received a brilliant 85 questions across the event!
Take a look below for further details on the topics we covered each day.
Day 1 – EU CTR
Day 1 focused on the topic of the EUCTR and regulations.
During the first presentation of the day EUCTR Update from the EMA, Noémie Manent (EMA) shared an update regarding the current progress of the new EUCTR, approximately six months from when it came into force, on 31 January 2022, with the aim of ensuring the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
In the second presentation EUCTR – A Cross-sectional Study to Evaluate Trial Sponsors’ Initial Experiences with the Process, Pooja Phogat (Independent) provided an in-depth overview of a cross-sectional study performed to evaluate ten sponsors’ initial experiences with the new EUCTR and CTIS framework. The four key areas discussed were (1) the impact of the EUCTR on existing processes (transition from directive to regulation) (2) alignment across functions and departments (3) initial experience with the regulation and (4) challenges and mitigation strategies.
In the third presentation Navigating Transparency Requirements Under the EUCTR with AI/ML-driven Solutions, David Di Valentino (Privacy Analytics) detailed the technical elements for protecting confidential information and participant privacy via AI/ML approaches. Combined with redaction and anonymisation, this can help sponsors navigate the new transparency landscape under the EUCTR, existing regulations, and the future.
The fourth and final presentation of the day Future-proofing Patient Privacy and Driving a Global Anonymization Strategy in Your Organization by Elliot Zimmerman (Real Life Sciences) and Ahmed Eldafrawy (Real Life Sciences) showed insights into embracing a holistic and consistent approach to disclosure that considers both efficiency and consistency in supporting and balancing risk of re-identification with wide-ranging requirements such as company policies, regulatory compliance, and internal and external sharing.
Day 2 – Patient Engagement
Day 2 focused on the topic of Patient Engagement.
During the first presentation Accelerated Sharing of COVID-19 Trial Data via the Vivli Global Data Sharing Platform, Rebecca Li (Vivli) and Rebecca Sudlow (Roche) shared their insights into how the COVID global pandemic has increased the need for accelerated data sharing and scientific progress, which can be accomplished through platforms such as the one developed by Vivli. Together, they reported on their initial experience of this accelerated process and highlighted some challenges they faced in using this approach.
In the second presentation A Systematic Review of Data Protection Approaches Across 31 Sponsors, Aaron Mann (Clinical Research Data Sharing Alliance) and Luk Arbuckle (Privacy Analytics) jointly discussed a systematic review of data sharing policies and applied data protection methodologies across 29 industry sponsors. They laid out the approach they took to conduct this review, including a Clinical Trial Secondary Use Survey, as well as previewed the preliminary results from their assessments. The full survey results and analysis will be made available in a publication later this year.
In the third presentation Plain Language Summaries, Dissemination, and the Quality of Engagement, Lee Holland (Xogene) and Deborah Collyar (Patient Advocates in Research) discussed strategies for the dissemination of plain language summaries (PLS), and the need to adopt quality measures to enhance the effectiveness of PLS dissemination and subsequent engagement. Quality measures can be included in value-based contracts with vendors to reduce costs, and also be used to establish industry-wide standards for PLS creation and dissemination.
In the final presentation of the day Educate the General Population on Data Privacy and Data Sharing, Devaki Thavarajah (PHUSE) shared an update on a project being undertaken by the PHUSE Data Transparency Working Group to create engaging short videos on data privacy and data sharing that can be understood and used by the general population. These bite-sized videos are intended to cover commonly asked questions about clinical trials, including why the data is needed, what data privacy is and where the data goes after collection.
Day 3 – Anonymisation
Day 3 focused on anonymisation methods, and experiences with anonymisation and usage of anonymised data.
The first presentation Sharing Anonymized and Functionally Effective (“SAFE”) Data by Stephen Bamford (Janssen Research & Development) and Luk Arbuckle (Privacy Analytics) introduced the SAFE standard developed and published by the two companies, which provides a framework for standardising risk assessment according to the data sharing context and controls from internal secure research reuse to data shared under an open data licence. The presentation also outlined the benefit of data sharing and the duty to proceed with a responsible and defendable approach when it comes to data anonymisation.
Alex Hughes (Roche) presented Coming in to Land! A Case Study in Software Deployment and Execution Strategies, which detailed Roche’s business case for selecting a solution for data anonymisation and the most important criteria in their search. They highlighted the expected features in terms of anonymisation capabilities (quantitative risk assessment, text replacement, etc.), the technical requirements related to hosting and maintenance, the process to consider as well as in-sourcing/outsourcing models for carrying out the tasks, and Roche’s choices with regard to hybrid approaches.
The third presentation Utilizing Privacy-compliant Subject-level Advanced Anonymization for RWE and Clinical Trial Data by Agnieszka Klawiter-Tsallos and Timo Miettinen (Bayer) introduced us to Bayer’s collaboration with the Finnish health authorities to use anonymised RWE data as an external control arm in combination with Bayer’s clinical study data. The presentation detailed some of the requirements imposed on anonymisation by the Finnish health authorities (e.g. k-anonymity (K=5) and t-closeness (t=0.5)) as well as an assessment of data quality on anonymised data.
In the final presentation of the day Disclosure of Adverse Events in Anonymized Documents, by Aga Glowińska and Julie Holtzople (AstraZeneca), Agnieszka walked us through an example of how anonymising sensitive data in narratives within a CSR could also lead to redaction in summary tables in cases of low frequencies.
Recordings and presentations are now available for on-demand viewing, so if you missed any or part of the event or would like to rewatch your favourite presentations, you can do so over on the PHUSE Engagement Hub.
Thank You
As always, PHUSE would like to give a big thank you to all involved in making this another successful event – especially to our sponsors, who this work would not be possible without.
