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Focal Points of SAS Forum

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d-wise just left the SAS Clinical Trial Data Transparency Forum in Heidelberg. There were three main focal points being discussed: success stories of data transparency, being prepared for public disclosure of documents, and that patient privacy is key.

Dave Handelsman discussed the collection and uses for the data at Project Datasphere. The prostate Cancer Dream challenge had >500 participants, 58 teams, and 21 countries. The data they collected and shared led to either directly or indirectly 9 peer accepted publications.

Jean Marc Ferran discussed the similarities and the inconsistencies between the sharing policies of EMA, Health Canada and the FDA. There was concerns raised at the possibility to request retrospective documents from Health Canada that do not have a time limit. Luckily, Health Canada has put in place a recognition process with EMA Policy 0070 documents.

We were excited to hear d-wise's Cathal Gallagher during the panel discussion. There was large consensus at the panel discussion that qualitative risk assessment and redaction will simply not be good enough for the future of transparency. The agencies are pushing for quantitative risk assessments combined with anonymization techniques.

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