Blog
RSS FeedPosted by Michael Wonder on 19 Jul 2019
Patient registries may prove valuable in regulatory decisions, EMA study finds
18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug ...
Posted by Michael Wonder on 16 Jul 2019
Gilead and Novartis seek to expand what FDA considers as real-world data and real-world evidence
15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...
Posted by Michael Wonder on 09 Jul 2019
FDA leverages private sector technology-based tools in its embrace of real world evidence
9 July 2019 - Following decades of near total reliance on randomised clinical trial data, the U.S. FDA (with a ...
Posted by Michael Wonder on 04 Jul 2019
Attempt to replicate clinical trials with real world data generates real world criticism, too
3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...
Posted by Michael Wonder on 29 Jun 2019
NICE explores extending its use of data to inform its guidance
25 June 2019 - NICE has revised its earlier press release on the use of real world data to inform ...
Posted by Michael Wonder on 26 Jun 2019
Real world evidence: the future is here
26 June 2019 - Use of real-world evidence is becoming increasingly common to aid the clinical development process and provide ...
Posted by Michael Wonder on 25 Jun 2019
NICE explores extending its use of real world data to inform its guidance
25 June 2019 - NICE is looking to extend the use of real world data that will help inform its ...
Posted by Michael Wonder on 25 Jun 2019
Do cancer treatments have option value? Real‐world evidence from metastatic melanoma
24 June 2019 - A change in the expectations about future treatments may change the option value of a current ...
Posted by Michael Wonder on 16 Jun 2019
How to deal with the inevitable: generating real-world data and using real-world evidence for HTA purposes – from theory to action
14 June 2019 - Real-world evidence, derived from real-world data, is already used, to some extent, for health technology assessment purposes. ...
Posted by Michael Wonder on 30 May 2019
Use of real world data sources for Canadian drug pricing and reimbursement decisions: stakeholder views and lessons for other countries
29 May 2019 - Canada has a long history of the use of clinical evidence to support health care decision making. ...
Posted by Michael Wonder on 09 May 2019
FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...
Posted by Michael Wonder on 10 Apr 2019
The evolving uses of “real world” data
9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to ...
Posted by Michael Wonder on 27 Mar 2019
Effectiveness in the absence of efficacy: cautionary tales from real world evidence
21 March 2019 - Real-world data are collected outside of traditional clinical trials and may include electronic health records, patient registries, ...