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.
- 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
Evaluating the re-identification risk of a clinical study report anonymized under EMA Policy 0070 and Health Canada Regulations
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".
Following are links to useful resources. This is by no means a compressive list, but provides some links for further reading.
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)
No upcoming events at this time.