ESIG of the Month - October 2021

Oct 15, 2021, 10:28 AM

Why do we have a Data Sharing ESIG?
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. Dataset re-use is increasingly becoming part of good trial practice e.g. use of historical control arm data for planning, adding together the findings from many trials, and doing methodology work to improve the way we do future trials. Alongside this, clinical trial documents are increasingly required to be open to access to the public within the regulatory framework (e.g. EMA Policy 70, EU CTR).  All this is challenging, as both the data privacy and the regulatory framework continue to evolve.

Who are we?
This ESIG comprises statisticians (both from pharma and academia) and some policy experts who are working or have interest in the data re-use, data privacy and data sharing space.

What’s our purpose?
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 data privacy concepts 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.

Want to know more?
Check out the resources we have on our ESIG page.

Would you like to join us?
New members are welcome! If you’re interested in finding out more please contact Rebecca Sudlow or Mimmi Sundler for further information.

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