Blog
RSS FeedPosted by Michael Wonder on 16 Nov 2023
Data sharing a a new era for research funded by the US Government
15 November 2023 - In January 2023, the NIH implemented its new Data Management and Sharing Policy. ...
Posted by Michael Wonder on 13 Dec 2022
Target trial emulation: a framework for causal inference from observational data
12 December 2022 - Quantifying the effect of a treatment on a clinical outcome—causal inference—requires the comparison of outcomes under different ...
Posted by Michael Wonder on 06 Dec 2022
Data sharing and the growth of medical knowledge
5 December 2022 - In medical research, data sharing facilitates discovery and innovation, transparency, and reproducibility, and, ultimately, trust in ...
Posted by Michael Wonder on 01 Dec 2022
Afraid of pharma pushback, a health data broker puts up a barrier to drug pricing information
1 December 2022 - At a time when many Americans are clamouring for more transparency into prescription drug pricing, one ...
Posted by Michael Wonder on 10 Oct 2022
High quality data to empower data-driven medicines regulation in the European Union
10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...
Posted by Michael Wonder on 04 Aug 2022
U.S. regulators defend requiring more data on monkeypox drug
4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...
Posted by Michael Wonder on 28 Jul 2022
Big data use for public health: publication of Big Data Steering Group workplan 2022-25
28 July 2022 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
Posted by Michael Wonder on 09 May 2022
Choices that fail health and wellbeing
5 May 2022 - NICE's expert group RAPID C-19, set up to ‘to ensure safe and timely patient access to treatments ...
Posted by Michael Wonder on 19 Apr 2022
Supply related data in manufacturer dossiers: things are not going smoothly yet
19 April 2022 - The criteria for supply related data established by IQWiG in 2020 were positively received in science. ...
Posted by Michael Wonder on 26 Feb 2022
COVID-19 vaccines: individual patient data should be submitted to the European Medicines Agency
24 February 2022 - An interesting letter to the Editor of the BMJ from the Head of Drug Assessment at ...
Posted by Michael Wonder on 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 15 Feb 2022
WHO’s new International Classification of Diseases (ICD-11) comes into effect
11 February 2022 - The World Health Organization Eleventh Revision of the International Classification of Diseases (ICD-11) has now come ...
Posted by Michael Wonder on 13 Feb 2022
The FDA and its new commissioner must follow the science
13 February 2022 - The FDA has the awesome responsibility to protect public health by ensuring the safety and effectiveness of ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...