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 28 Oct 2019
NICE to support new valuation study for England for EQ-5D-5L questionnaire
24 October 2019 - Study will measure public’s preference for different health states. ...
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 08 Feb 2019
EMA launches checklist to facilitate validation for initial marketing authorisation applications
8 February 2019 - A survey launched by EMA in September 2016 shows that validation issues occur in 90% of ...
Posted by Michael Wonder on 07 Dec 2017
NICE launches PRIMA to health-check economic models
7 December 2017 - NICE Scientific Advice offers a new service for healthcare product developers to check the quality of their ...
Posted by Michael Wonder on 30 Oct 2017
Predictive validation and the re-analysis of cost-effectiveness: do we dare to tread?
30 October 2017 - Predictive validation (also known as fourth-order validation) involves the comparison between model outputs and observed data ...
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 ...