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RSS FeedPosted 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FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...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 ...
Posted by Michael Wonder on 23 Aug 2018
Case-control studies: using “real world” evidence to assess association
23 August 2018 - Associations between patient characteristics or treatments received and clinical outcomes are often first described using observational data, ...
Posted by Michael Wonder on 14 Aug 2018
Five predictions for AI and real world data in oncology
14 August 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work ...
Posted by Michael Wonder on 13 Aug 2018
Real world evidence and real world data for evaluating drug safety and effectiveness
13 August 2018 - For hundreds of years, the development of new medical treatments relied on “real-world” experience. ...
Posted by Michael Wonder on 13 Jul 2018
PhRMA statement on efforts to support real world evidence
12 July 2018 - PhRMA spokesperson Andrew Powaleny issued the following statement on comments made by U.S. FDA Commissioner Scott Gottlieb. ...
Posted by Michael Wonder on 10 Jul 2018
FDA budget matters: a cross-cutting data enterprise for real world evidence
10 July 2018 - Over time, as our experience with new medical products expands, our knowledge about how best to maximise ...