Nothing about us without us

2019-11-03T12:56:57+00:00November 1st, 2019|Categories: Regulatory Landscape|

That was the rallying cry from both investigators and patients at a public meeting on ICH E8 R1, General Considerations for Clinical Studies, held at FDA yesterday. I joined a Webex of the proceedings at different points during the day. The changes to the guideline are significant. It promotes fit for purpose clinical trials by [...]