Blog
RSS FeedPosted by Michael Wonder on 27 Apr 2025
The role and value of real-world evidence in health technology decision-making in France, Germany, Italy, Spain, and the UK: insights on external control arms
22 April 2025 - Real-world evidence is increasingly used and accepted by health technology assessment (HTA) bodies as supportive evidence ...
Posted by Michael Wonder on 03 Apr 2025
Real-world evidence to support health technology assessment and payer decision making: is it now or never?
31 March 2025 - The aim of this policy article is twofold: (i) to provide a summary and update of recent ...
Posted by Michael Wonder on 01 Feb 2025
The use of real world data for estimating relative treatment effects in NICE health technology assessment submissions: a review
1 February 2025 - This paper investigates the current use of real world data for estimating relative treatment effects in NICE ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 09 Aug 2024
Canada’s Drug Agency taking steps to expand access to real world evidence
7 August 2024 - Canada’s Drug Agency has published a summary report from its time-limited Industry Task Force. ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 23 May 2024
COTA announces extended collaboration with FDA to advance the use of real world data in cancer research
22 May 2024 - Today, COTA announced an extension of its research collaboration with the US FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 16 May 2024
Acceptability of using real world data to estimate relative treatment effects in health technology assessments: barriers and future steps
15 May 2024 - Evidence about the comparative effects of new treatments is typically collected in randomised controlled trials (RCTs). In ...
Posted by Michael Wonder on 15 Feb 2024
Launch of new HMA-EMA catalogues of real world data sources and studies
15 February 2024 - The EMA and the Heads of Medicines Agencies have launched two public electronic catalogues: one for ...
Posted by Michael Wonder on 22 Nov 2023
Updates to the HTA Review Research and Analysis papers collection: draft HTA expert paper published
22 November 2023 - The draft paper 'Optimising the availability and use of real world data and real world evidence to ...
Posted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 28 Aug 2023
CADTH to establish industry task force on real world data for post market drug evaluations
18 August 2023 - CADTH is establishing an industry task force that will build upon the recently released guidance for reporting ...
Posted by Michael Wonder on 28 Jun 2023
Facilitating review of real world data studies: the oncology QCARD initiative
27 June 2023 - Expanding ways to generate evidence can lead to an array of benefits for medical product development, including ...
Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
Posted by Michael Wonder on 05 Jun 2023
Guidance for reporting real world evidence
31 May 2023 - CADTH has partnered with Health Canada, the Institut national d’excellence en santé et en services sociaux (INESSS), ...