Blog
RSS FeedPosted by Michael Wonder on 16 Oct 2019
RWE to supplement RCTs: FDA projects continue
15 October 2019 - The US FDA has been working with several different data and research companies to further its ...
Posted by Michael Wonder on 30 Sep 2019
Harnessing the patient voice in real world evidence: the essential role of patient-reported outcomes
30 September 2019 - Real-world evidence is increasingly valued by regulators and payers. ...
Posted by Michael Wonder on 29 Sep 2019
FDA announces a new Sentinel System contract, affirming its commitment to harnessing real-world data to improve the safety and effectiveness of drugs
27 September 2019 - Today, the U.S. FDA is announcing an award granting a new five-year contract for the Sentinel ...
Posted by Michael Wonder on 22 Sep 2019
Accelerating the shift toward person-generated real world evidence
19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...
Posted by Michael Wonder on 09 Sep 2019
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 ...
Posted by Michael Wonder on 04 Sep 2019
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. ...
Posted by Michael Wonder on 26 Aug 2019
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, ...
Posted by Michael Wonder on 21 Aug 2019
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 ...
Posted by Michael Wonder on 14 Aug 2019
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 ...
Posted by Michael Wonder on 11 Aug 2019
The evolution of real world studies
9 August 2019 - The use of real-world evidence is evolving quickly. ...
Posted by Michael Wonder on 27 Jul 2019
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 ...
Posted 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 ...