Blog
RSS FeedPosted by Michael Wonder on 08 Oct 2020
Use of real world evidence to support FDA approval of oncology drugs
8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials. ...
Posted by Michael Wonder on 06 Oct 2020
ISPOR’s real world evidence transparency initiative: creating a road map that builds trust
5 October 2020 - Transparency of Data, Methods, Analyses, and Results Will Increase Confidence in Study Credibility. ...
Posted by Michael Wonder on 05 Oct 2020
Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product
5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...
Posted by Michael Wonder on 22 Sep 2020
Taking steps toward transparency in real world evidence studies
22 September 2020 - The level of trust in health economics and outcomes research studies has been an on-going concern owing ...
Posted by Michael Wonder on 17 Sep 2020
Real world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward
15 September 2020 - There is growing interest globally in using real world data and real-world evidence for health technology assessment. ...
Posted by Michael Wonder on 05 Sep 2020
Real world evidence to support payer/HTA decisions about highly innovative technologies in the EU—actions for stakeholders
3 September 2020 - There are divergent views on the potential of real world data to inform decisions made by regulators, ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 real-world evidence and observational studies
31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...
Posted 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 ...