When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show ...
Pharma and biotech companies have access to an unprecedented variety of health data, from electronic health records and medical or pharmacy claims to genomic, behavioral and sensor data. Yet it can be ...
In this episode we are joined by Eric Fontana, VP of Client Solutions at Optum Life Sciences; Bethany Kalich, U.S. Medical Director, Cardiovascular at Amgen; and Christen Buseman, Director, IDN ...
Angela Jia, MD, PhD, is a radiation oncologist specializing in stereotactic body radiation therapy (SBRT), adaptive radiotherapy, and clinical trials focused on prostate, bladder, and kidney cancers.
Real-world evidence helps pharmaceutical companies and payers communicate more effectively. In this Q&A, Cate Lockhart, PharmD, PhD, chief science officer of the Academy of Managed Care Pharmacy (AMCP ...
The traditional process for evaluating new therapeutics may not generate the evidence that patients, clinicians, and payers need to make real-world decisions. The volume and complexity of information ...
The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
Healthcare systems worldwide are facing unprecedented pressure, from the rise in chronic diseases and aging populations to fragmented healthcare and over-stretched resources. The result? Delayed, ...
Key market opportunities in the global real-world evidence (RWE) solutions market include growing regulatory acceptance and guidance from global agencies, increased R&D spending, and rising ...
Randomized, controlled clinical trials (RCTs) have traditionally served as the gold standard for evidence generation in support of medical product development and approval. However, it is increasingly ...
The U.S. Food and Drug Administration announced a major shift in its approach to real‑world evidence (RWE). In new guidance for certain medical device submissions, FDA will accept RWE without always ...
This story has been updated with additional comments from Datavant. Health tech company Datavant is making moves to be a bigger player in the real-world data space. The company announced Thursday that ...
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