Blog
RSS FeedPosted by Michael Wonder on 08 Feb 2021
International regulators working together to enhance collaboration on COVID-19 observational research
8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...
Posted by Michael Wonder on 14 Jan 2021
Workshop on evaluating RWE from observational studies in regulatory decision-making
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
Posted by Michael Wonder on 12 Jan 2021
STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...
Posted by Michael Wonder on 30 Nov 2020
ICER Analytics launched to accelerate the real world application of ICER reports, helping payers, the life science industry, and health care policy makers move from insight to action
30 November 2020 - The Institute for Clinical and Economic Review today formally launched ICER Analytics, a new cloud-based platform that ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted 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 ...