Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 25 Mar 2020
FDA announces funding opportunity to explore the use of real-world data to generate real-world evidence in regulatory decision making
25 March 2020 - The U.S. Food and Drug Administration is announcing a funding opportunity for projects to support the ...
Posted by Michael Wonder on 24 Feb 2020
Drug pricing review group signs deal with Aetion for patient data
24 February 2020 - The Institute for Clinical and Economic Review (ICER), a small but influential Boston-based research group, has ...
Posted by Michael Wonder on 24 Feb 2020
ICER and Aetion partner to develop real-world evidence for value assessment of treatments
24 February 2020 - ICER adopts Aetion’s Real-World Evidence Platform — advancing standards for the use of transparent, replicable real-world ...
Posted by Michael Wonder on 24 Feb 2020
Real world evidence - from safety to a potential tool for advancing innovative ways to develop new medical therapies
24 February 2020 - Real world evidence has the potential to enhance the efficiency of drug development and provide new evidence ...
Posted by Michael Wonder on 16 Feb 2020
RWE: cost and time savings entice sponsors as pitfalls linger
14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...
Posted by Michael Wonder on 13 Feb 2020
The magic of randomisation versus the myth of real world evidence
12 February 2020 - Non-randomised observational analyses have been promoted as alternatives to randomised clinical trials. ...
Posted by Michael Wonder on 14 Jan 2020
Basket cases: how real-world testing for drugs approved based on basket trials might lead to false diagnoses, patient risks, and squandered resources
14 January 2020 - Basket trials, studies designed to assess the safety and efficacy of therapeutics targeted to a specific molecular ...
Posted by Michael Wonder on 09 Jan 2020
FDA real world evidence to be made available on Google Cloud
8 January 2020 - The company is making the agency's open-source MyStudies platform available, enabling for easier access to data for ...
Posted by Michael Wonder on 16 Oct 2019
RWE to supplement RCTs: FDA projects continue
15 October 2019 - The US FDA has been working with several different data and research companies to further its ...
Posted by Michael Wonder on 30 Sep 2019
Harnessing the patient voice in real world evidence: the essential role of patient-reported outcomes
30 September 2019 - Real-world evidence is increasingly valued by regulators and payers. ...
Posted by Michael Wonder on 29 Sep 2019
FDA announces a new Sentinel System contract, affirming its commitment to harnessing real-world data to improve the safety and effectiveness of drugs
27 September 2019 - Today, the U.S. FDA is announcing an award granting a new five-year contract for the Sentinel ...
Posted by Michael Wonder on 22 Sep 2019
Accelerating the shift toward person-generated real world evidence
19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...
Posted by Michael Wonder on 09 Sep 2019
FDA developing guidance on real world data quality issues, officials say
9 September 2019 - As the US FDA grapples with how to use real-world data for regulatory decisions, two FDA ...