Reposted by Tobias Fellinger
EMA experts explore why we shouldn't focus on setting a requirement for a number of clinical trials.
One pivotal trial, or two? What matters is generating evidence that addresses patients’ needs and supports a positive benefit–risk balance.
Read the article: www.nature.com/articles/s41...
nature.com
Two trials or not two trials? That should not be the question - Nature Reviews Drug Discovery
Nature Reviews Drug Discovery - Two trials or not two trials? That should not be the question