FDA developing guidance on real world data quality issues, officials say

9 September 2019 - As the US FDA grapples with how to use real-world data for regulatory decisions, two FDA ...

Read more →

Releasing the potential of real world evidence

4 September 2019 - Janssen believes RWE could realise an efficient, personalised and truly patient-centric health care system. ...

Read more →

Developing real-world data and evidence to support regulatory decision-making

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...

Read more →

Former FDA Commissioners seek to expand use of RWE in regulatory, payment decisions

21 August 2019 - A new report from the Bipartisan Policy Center makes recommendations to expand the use of real-world ...

Read more →

Syapse announces research collaboration with the FDA focused on the regulatory use of real-world evidence

14 August 2019 - Collaboration will advance the derivation of real-world oncology endpoints and provide insights into the use of real-world ...

Read more →

The evolution of real world studies

9 August 2019 - The use of real-world evidence is evolving quickly. ...

Read more →

Australian study evaluates real world evidence of Botox to prevent migraine

26 July 2019 - OnabotulinumtoxinA has been approved by Australia’s reimbursement mechanism for medicines, the PBS, for preventive treatment of ...

Read more →

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 ...

Read more →

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15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →