Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2022
Simulating colorectal cancer trials using real world data
20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...
Posted by Michael Wonder on 11 Jul 2022
The (harsh) reality of real-world data external comparators for health technology assessment
8 July 2022 - We read with great interest the recently published article by Patel et al. and commend the authors ...
Posted by Michael Wonder on 20 Jun 2022
Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...
Posted by Michael Wonder on 25 May 2022
Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real world data: opportunities and challenges
25 May 2022 - Evidence about the relative effects of new treatments is typically collected in randomised controlled trials. ...
Posted by Michael Wonder on 12 May 2022
CADTH expands scientific advice program to include advice on real world evidence
28 April 2022 - CADTH is expanding its scientific advice program to include applications for advice on real world evidence generation ...
Posted by Michael Wonder on 05 May 2022
Real world evidence - where are we now?
4 May 2022 - Notwithstanding on-going confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 ...
Posted by Michael Wonder on 08 Mar 2022
ISPOR launches “About Real-World Evidence” content
8 March 2022 - Introductory information is designed to make RWE more accessible for health care audiences. ...
Posted by Michael Wonder on 12 Feb 2022
Industry cites outdated standards as flaw in FDA’s real world data draft guidance
11 February 2022 - The US FDA should adopt updated data standards that accommodate the “evolving and emerging” nature of ...
Posted by Michael Wonder on 09 Feb 2022
Initiation of DARWIN EU Coordination Centre advances integration of real world evidence into assessment of medicines in the EU
9 February 2022 - EMA is initiating today the establishment of the Coordination Centre for the Data Analysis and Real ...
Posted by Michael Wonder on 01 Feb 2022
CDER explores series of draft guidances on real world data, real world evidence - drug information update
31 January 2022 - Collection and analysis of real world data continue to gain traction in the biomedical community, accompanied by ...
Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...
Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
Posted by Michael Wonder on 24 Nov 2021
A vision for use of real world evidence in EU medicines regulation
24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 28 Oct 2021
FDA acknowledges hurdles in utilising real world data
28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into ...