FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications

8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...

Read more →

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? ...

Read more →

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 ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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, ...

Read more →

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 ...

Read more →

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.  ...

Read more →

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. ...

Read more →

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 ...

Read more →