Blog
RSS FeedPosted by Michael Wonder on 21 Jul 2020
Harnessing real world data for regulatory use and applying innovative applications
22 July 2020 - A vast quantity of real world data are available to health care researchers. ...
Posted by Michael Wonder on 21 Jul 2020
EMA sets up infrastructure for real-world monitoring of COVID-19 treatments and vaccines
21 July 2020 - EMA has now set up an infrastructure to support the monitoring of the efficacy and safety ...
Posted by Michael Wonder on 14 Jul 2020
NICE partners with Flatiron Health to develop real world evidence research methodologies
14 July 2020 - Collaboration will help NICE expand use of real world data in service of better outcomes for UK ...
Posted by Michael Wonder on 12 Jul 2020
Real world evidence use in assessments of cancer drugs by NICE
10 July 2020 - Single technology assessments published by NICE from April 2011 to October 2018 that evaluated cancer treatments were ...
Posted by Michael Wonder on 27 May 2020
EMA commissions independent research to prepare for real world monitoring of COVID-19 vaccines
27 May 2020 - EMA is engaging early with researchers to ensure that a European infrastructure will be in place to ...
Posted by Michael Wonder on 19 May 2020
(COVID-19) update: FDA collaborations promote rigorous analyses of real world data to inform pandemic response
19 May 2020 - Today, the FDA is announcing another step in our effort to harness diverse streams of data to ...
Posted by Michael Wonder on 16 Apr 2020
Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data
16 April 2020 - Observational studies of data generated in clinical practice in the context of COVID-19 can contribute to the ...
Posted by Michael Wonder on 07 Apr 2020
Global regulators discuss observational studies of real world data for COVID-19 medicines
7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...
Posted by Michael Wonder on 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 25 Mar 2020
FDA announces funding opportunity to explore the use of real-world data to generate real-world evidence in regulatory decision making
25 March 2020 - The U.S. Food and Drug Administration is announcing a funding opportunity for projects to support the ...
Posted by Michael Wonder on 24 Feb 2020
Drug pricing review group signs deal with Aetion for patient data
24 February 2020 - The Institute for Clinical and Economic Review (ICER), a small but influential Boston-based research group, has ...
Posted by Michael Wonder on 24 Feb 2020
ICER and Aetion partner to develop real-world evidence for value assessment of treatments
24 February 2020 - ICER adopts Aetion’s Real-World Evidence Platform — advancing standards for the use of transparent, replicable real-world ...
Posted by Michael Wonder on 24 Feb 2020
Real world evidence - from safety to a potential tool for advancing innovative ways to develop new medical therapies
24 February 2020 - Real world evidence has the potential to enhance the efficiency of drug development and provide new evidence ...
Posted by Michael Wonder on 16 Feb 2020
RWE: cost and time savings entice sponsors as pitfalls linger
14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...
Posted by Michael Wonder on 13 Feb 2020
The magic of randomisation versus the myth of real world evidence
12 February 2020 - Non-randomised observational analyses have been promoted as alternatives to randomised clinical trials. ...