Blog
RSS FeedPosted by Michael Wonder on 13 Sep 2022
FDA finalises guidance on submitting RWD/RWE in application cover letters
13 September 2022 - To help better track submissions that include real world data and real world evidence, the US ...
Posted by Michael Wonder on 08 Sep 2022
Submitting documents using real world data and real world evidence to FDA for drug and biological products
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...
Posted by Michael Wonder on 05 Sep 2022
Clinical trials: real world data plays early role in efforts to increase diversity
5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...
Posted by Michael Wonder on 10 Aug 2022
Real-world data can help expedite drug approvals for serious diseases with few options
10 August 2022 - My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she ...
Posted by Michael Wonder on 09 Aug 2022
Introducing CADTH’s RWE Guidance Working Group
9 August 2022 - CADTH is pleased to announce the introduction of the Real-World Evidence Guidance Working Group. ...
Posted by Michael Wonder on 03 Aug 2022
Connecting electronic health records to clinical trials: how to embrace the promise of real world data
3 August 2022 - We all know that real world data from electronic health records could boost clinical trial efficiency ...
Posted by Michael Wonder on 22 Jul 2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
Posted 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. ...