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European Hematology Association tentatively responds to the European Commission’s proposal to improve clinical research
In addition, the regulation appears to accommodate multi-national trials with, for instance, a harmonized authorization dossier, and a single submission system.
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Clinical trials
The advance of highly innovative, increasingly personalized therapies in hematology requires novel clinical trial designs and more flexible, adaptive regulatory frameworks and improved data generation to support decision making both during and after clinical studies.
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