PSI Webinar: Master protocols - theory, application and regulatory considerations
For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies.
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 discussion in this area.
Our objectives include:
1. Promote an understanding of the challenges and responsibility 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.
|Rebecca Sudlow (Chair)||Roche|
|Hoi Shen Radcliffe||Amgen|
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.
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
Following are links to useful resources. This is by no means a compressive list, but provides some links for further reading.
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.