Blog
RSS FeedPosted by Michael Wonder on 23 Nov 2022
DARWIN EU welcomes first data partners
23 November 2022 - EMA has selected the first set of data partners to collaborate with DARWIN EU, the Data Analysis ...
Posted by Michael Wonder on 11 Nov 2022
CADTH launches consultation on real world evidence reporting guidance
10 November 2022 - Today, CADTH, on behalf of the Real World Evidence Steering Committee, launched a public consultation to ...
Posted by Michael Wonder on 07 Nov 2022
Can we use existing guidance to support the development of robust real world evidence for health technology assessment/payer decision-making?
2 November 2022 - Advances in the digitisation of health systems and expedited regulatory approvals of innovative treatments have led to ...
Posted by Michael Wonder on 25 Oct 2022
A perspective on life cycle health technology assessment and real world evidence for precision oncology in Canada
25 October 2022 - Health technology assessment can be used to make healthcare systems more equitable and efficient. Advances in precision ...
Posted by Michael Wonder on 19 Oct 2022
Advancing real world evidence program
19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...
Posted by Michael Wonder on 13 Oct 2022
HARmonized protocol template to enhance reproducibility of hypothesis evaluating real world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR Task Force
12 October 2022 - Ambiguity in communication of key study parameters limits the utility of real-world evidence studies in health care ...
Posted by Michael Wonder on 10 Oct 2022
High quality data to empower data-driven medicines regulation in the European Union
10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...
Posted by Michael Wonder on 27 Sep 2022
NICE recommends NHS collects real world evidence on devices that monitor people with Parkinson’s disease
27 September 2022 - Five promising technologies that could help improve symptoms and quality of life for people with Parkinson’s disease ...
Posted 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 ...