tag real-world-evidence 
Rethinking Clinical Trials
JUNE 29, 2022
Associate Director for Real-World Evidence Analytics. Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. Real-world data (RWD) is a term with specific regulatory implications referring to health care data routinely collected from a variety of sources.
Rethinking Clinical Trials
JUNE 14, 2023
The second aim is to test the transparent and reproducible process with the FDA to evaluate Real World Evidence (RWE) studies. It’s useful to lay out the parameters, or all of the questions to define the estimate for the target trial, whether hypothetical or real.
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The Pharma Data
FEBRUARY 22, 2022
As part of its on-going work to track variants, WHO’s Technical Advisory Group on SARS-CoV-2 Virus Evolution ( TAG-VE ) met yesterday to discuss the latest evidence on the Omicron variant of concern, including its sublineages BA.1 Reinfection with BA.2 2 following infection with BA.1 WHO will continue to closely monitor the BA.2
Rethinking Clinical Trials
MARCH 28, 2023
It has grown to be a major force for supporting pragmatic research, both real-world evidence research and supporting observational research and pragmatic clinical trials. It is an independent, nonprofit, research institute and leading funder of patient-centered comparative clinical effectiveness research (CER).
XTalks
FEBRUARY 27, 2024
Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.
pharmaphorum
JUNE 8, 2021
In a statement on the approval, ICER said the view of many experts was that current evidence is simply not enough to support the use of aducanumab in Alzheimer’s patients, and the FDA had “moved the goalposts” by not holding Biogen’s drug to the standards of other therapies.
The Pharma Data
MAY 4, 2021
In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. RE47,739 for Ibrance by more than four years until March 2027.
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