Blog
RSS FeedPosted by Michael Wonder on 11 Jan 2023
CDER director calls for simplifying clinical trials to boost diversity
10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is ...
Posted by Michael Wonder on 04 Jul 2019
Attempt to replicate clinical trials with real world data generates real world criticism, too
3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...
Posted by Michael Wonder on 03 Jul 2019
Validation of patient reported outcomes: a low bar
3 July 2019 - It used to be that if we wanted to assess a patient’s back pain, we would evaluate ...
Posted by Michael Wonder on 16 Mar 2016
Biomarkers and surrogate endpoints
16 March 2016 - This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common ...