2nd Workshop, Paris: “New Methodologies for Clinical Trials in Small Populations”
July 2005
This workshop was the opportunity to explore the advantages of applying alternative methodologies when the restrictions due to the variety of rare diseases do not allow a classical trial to be conducted. The compromise positions identified are at the cost of increased uncertainty concerning the reliability of the results and hence the reliability of the effectiveness, safety and risk–benefit of the product.
Participants: 49
Key feature: presentation of the EMEA’s draft guidelines on Clinical Trials in Small Populations and discussion with all the stakeholders
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Proceedings
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