Sushmita Sen: How are We Doing in Global Clinical Trials and Precision Hematology?
Sushmita Sen, Global Medical Scientific Alliances in Oncology and Hematology at Roche, shared a post on LinkedIn:
“How are we doing in Global Clinical Trials and Precision Hematology?
Two back to back outstanding sessions tried to answer that at the European Hematology Association (EHA) Annual Meeting in Stockholm this afternoon.
Two personal observations from the sessions:
In the first session on multi-regional clinical trials (MRCT), FDA and EMA presented their already known views on the topic.
The existing differences between the two regulators in using evidence from multi-regional trials remain unresolved.
Probably the most insightful talk was on EMA’s thoughts on intrinsic and extrinsic factors within multi-regional data that impacts European populations.
What will it take the two regulators evaluate a study design together?
The second session walked us through the very complex process of In Vitro Diagnostics Regulation (IVDR) and evaluation of companion diagnostics (CDx) in Europe.
The intersection of IVDR with Clinical Trials Regulation (CTR) and Medical Device Regulation (MDR) in regulating diagnostics made my head spin!
I appreciated the panelists walking us through real world scenarios in clinical practice – which illustrated the processes behind the regulations.
Can we simplify the complex regulatory pathways to make Precision Hematology a reality for European patients?
Kudos to Robin Doeswijk, Gauthier Quinonez and the EHA Policy team for organizing these sessions.”
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