Blog
RSS FeedPosted 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FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...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, ...
Posted by Michael Wonder on 05 Mar 2019
Determining the comparative value of pharmaceutical risk-sharing policies in non–small cell lung cancer using real-world data
2 March 2019 - Risk-sharing arrangements can be used to mitigate uncertainty about the value of a drug by sharing the ...
Posted by Michael Wonder on 13 Feb 2019
Industry lauds FDA RWE framework, calls for tweaks
12 February 2019 - The US FDA regulatory framework for the use of real-world evidence drew positive reactions from biopharma ...
Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use ...
Posted by Michael Wonder on 07 Nov 2018
FDA releases real-world data collection app
7 November 2018 - FDA released on Tuesday an open source code app that can be used to collect real-world ...
Posted by Michael Wonder on 28 Sep 2018
Harnessing the potential of real world data through a ‘learning health care system'
28 September 2018 - Real world data hold the promise to substantially increase the effectiveness and efficiency of all processes ...
Posted by Michael Wonder on 22 Sep 2018
The FDA announces Patient Engagement Advisory Committee meeting on utilising real world data from patient-driven platforms that connect and empower patients
21 September 2018 - On 15 November 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting ...