ASH 2025 immunotherapy data highlight the importance of treatment sequencing, real-world outcomes in high-risk populations, ...
Certain low-risk or mature devices may see reduced trial requirements, but the broader trend is toward augmenting—not ...
Real-world evidence (RWE) empowers payers and providers to make more informed, cost-effective treatment. Read more here: ...
Clinical Trials Arena on MSN
From real to regulatory: why RWD needs trial-grade standards
Jen Lamppa, VP of Commercial Strategy at Inovalon, says that RWD will be held to the same scrutiny as trial data if used in regulatory submissions.
In chronic hepatitis B virus (HBV) infection, the central debate remains whom and when to treat. The 2025 European Association for the Study of the Liver (EASL) Clinical Practice Guidelines (CPGs)1 ...
Panelists discuss how RWE informs treatment and safety decisions for special populations such as patients with ECOG PS 2 with metastatic colorectal cancer. Panelists note that patients with ECOG ...
On December 17, the U.S. Food and Drug Administration (FDA) finalized its long-awaited guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” ...
In the largest real-world study of its kind with 428,707 patients, the Zio LTCM service outperformed other studied monitoring approaches in cardiac arrhythmia diagnostic yield, time to diagnosis, ...
Findings accepted for publication in the official journal of the American College of Allergy, Asthma and Immunology About 9 out of every 10 patients experiencing anaphylaxis were effectively treated ...
In today's healthcare environment, securing regulatory approval is only the beginning. The real challenge lies in ensuring ...
Next Health selected as a leading wellness and longevity partner given its innovative approach to personalized aesthetics and health optimization ...
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