ARTICLE | Regulation

Scrutinizing dose finding

How companies, EMA hope to improve dose-finding in Phase II

February 16, 2015 8:00 AM UTC

EMA officials have hinted they would be willing to approve drugs with less clinical data if companies employ more robust dose-finding methodologies, but companies want more than a hint before they abandon traditional dose-finding approaches.

At a workshop held in December, regulators from Europe and the U.S. as well as company representatives agreed the traditional dose-finding approach should be abandoned in favor of new modeling and simulation methodologies that better characterize the dose-response relationship. Both groups acknowledged that a better understanding of dose response can shorten development timelines and reduce overall costs for industry while giving regulators better data to make benefit-risk decisions...