When can real-world data generate real-world evidence?
Key Points In accordance with the 21st Century Cures Act of 2016 (Cures Act),1 the Food and Drug Administration (FDA or the Agency) launched a program for evaluating the use of...
Category: Industry News
European Data-Sharing Rules Could Make a Reality of RWD and RWE
Legislative efforts seek a common framework in accessing and applying real-world data and evidence in clinical studies. Discussions on current European legislative initiatives edge forward in drug approval and the...
Agencies Explore Policy Barriers, Synthetic Data to Maintain Health Care Privacy
Policy changes and synthetic data could play a key role in eliminating risks while improving data access and security. Nikki Henderson Fri, 09/22/2023 – 17:00 Federal leaders from NIH, VA,...
FDA’s Califf: Expect to see more RWE-based regulatory decisions
WASHINGTON – Use of electronic health records (EHR) to collect real-world evidence (RWE) that can then be used to expand a product’s indication is going to become more common, according...
Cancer Moonshot Initiative Receives $240 Million Boost
On September 13, during a meeting of the Cancer Cabinet, President Joe Biden and First Lady Dr. Jill Biden announced a $240 million investment to accelerate advances in cancer-related projects,...
Ensembling Synthetic Data and Digital Twin Technologies for Predictive Modeling in Life Sciences
Techniques to counter bias and elevate privacy for clinical trials Recent history, like the COVID-19 pandemic, has shown that the speed and accuracy of executing clinical trials in support of new...
Patient Privacy in Healthcare Analytics: The Role of Augmentation PETs
September 06, 2023 – Healthcare big data analytics efforts must strike a balance between making patient data accessible to researchers and guaranteeing that it is private and protected from unauthorized individuals. To...
FDA issues guidance on using real-world data for drug development
The FDA has released final draft recommendations for using real-world data and evidence in drug development. By Akosua Mireku The US Food and Drug Administration (FDA) has released a final draft...
AI-Generated Data Could Be a Boon for Healthcare—If Only It Seemed More Real
AI enables researchers to weave ‘synthetic data’ from sets of patient data. But CIOs question whether the generated data sufficiently captures the medical variables useful in research By Isabelle Bousquette Johnson...
Recognizing RWE as clinical data to speed up developing medical devices
The Ministry of Food and Drug Safety has decided to recognize real-world evidence (RWE) as clinical data in the approval process for digital technology-based medical devices. The ministry said Thursday that...