PSI Medical Statistics Careers Event
This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
Data Sharing SIG
Purpose
Clinical data has greater use beyond the original trial. These data can be used to further increase our scientific understanding of diseases and their treatment for the benefit of future patients. This re-use is a challenge, as both the data privacy and the regulatory framework continue to evolve. The members of this ESIG intend to lead the industry discussion in this area.
Objectives
Our objectives include:
1. Promote an understanding of the challenges and responsibility organisations and statisticians have when re-using or sharing clinical data.
2. Improve understanding, implementation and examples of anonymisation methodologies within the context of clinical trial
data sharing.
3. Influence and shape the environment and policies regarding clinical data sharing.
4. Collaborate with other groups and stakeholders in this area.
Who we are
| Name | Company/Institution |
| Rebecca Sudlow | Roche |
| Katherine Tucker | Roche |
| Chris Harbron | Roche |
| Lucy Frith | GSK |
| Janice Branson | Novartis |
| Christoph Gerlinger | Bayer |
| Mimmi Sundler | AstraZeneca |
| Catrin Tudor Smith | University of Liverpool |
| Carrol Gamble | University of Liverpool |
| Tamsin Sargood | Johnson & Johnson |
| Stef James | AstraZeneca |
| Matt Sydes | MRC Clinical Trials Unit at UCL |
| Michael Robling | Cardiff University |
| Birgitte Hylleberg Svendsen | Novonordisk |
| Lisa Winstanley | AstraZeneca |
How to get in touch
If you have any questions on this topic, need further information or wish to join the ESIG please contact Rebecca Sudlow. We are always looking for members from both industry and academia.
ESIG Resources
Publications: Data sharing in pharma, includes articles on:
- Statistical guidance for responsible data sharing: an overview,
- Protecting patient privacy when sharing patient-level data from clinical trials,
- Best practice for analysis of shared clinical trial data,
- EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers,
- Data sharing and the evolving role of statisticians
Members of the SIG have been behind a publication on "Synthetic Data Use: Exploring use cases to optimise data utility" published in Discover Artificial Intelligence
PSI Video on Demand library, includes recordings on:
PSI Webinar recordings - Anonymising Clinical Data, Data Sharing and Data Privacy – what every statistician needs to know
PSI Conference 2018 Recordings - Data Sharing in Practice, Novartis journey in implementing CDP including performing a motivated intruder attack
All materials can be located under the topic "Anonymising Clinical Data".
PSI Conference Webinar Series 2020 - Data as an asset: the re-use of data
Other Resources:
Following are links to useful resources. This is by no means a compressive list, but provides some links for further reading.
Regulatory:
EMA clinical data publication (policy 70)
EMA online access to clinical data for medicinal products
Health Canada guidance on the public release of clinical information
Data Sharing Platforms:
Clinical Study Data Request, consortium of clinical sponsors/funders providing access to patient-level data
Vivli: global clinical research data sharing platform
Other sources Phuse working group on de-identification
UK Anonymisation Network
EMA MRCT Conference report ‘Data anonymization: a key enabler for clinical data sharing’
Medical Research Council Regulatory Support Centre Guidance Note “Identifiability, Anonymisation and Pseudonymisation”
European Data Protection Board (EDPB) - Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR)
Upcoming Events
No upcoming events at this time.
