Protocol design does not struggle in the protocol. It struggles in the transition to trial, when assumptions embedded in the ...
In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
New guidelines have been developed to help researchers ensure that their clinical trial protocols and reports are complete, high-quality and transparent. Increased consistency across these documents ...
ASCO 2026 marked an important transition in oncology. Rather than showcasing isolated advances, the meeting demonstrated how ...
Dyne Therapeutics has announced a revised protocol for its ACHIEVE trial, elevating video hand opening time (vHOT) to the primary endpoint for U.S. Accelerated Approval of DYNE-101, a treatment for ...
In the second of a two-part article, Gabrielle Faure-André and Stéphanie Garçon at Santarelli unpick EPO, UPC and French case law to assess the importance of clinical development timelines in ...
The Hearty Soul on MSN
One specific diet reduces gum disease in 6-month trial
A 2026 King's College London trial found a fasting-mimicking diet reduced inflammatory markers in gum disease patients. The ...
In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...
AURORA targets a high-unmet-need population: metastatic non-squamous NSCLC with progression on pembrolizumab and platinum ...
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