Protocol design does not struggle in the protocol. It struggles in the transition to trial, when assumptions embedded in the ...
Older patients represent the fastest growing patient group in clinical care. They are a heterogeneous group, for whom evidence for making treatment decisions is often scarce. Important domains for ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...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 ...
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 ...
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 today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol ...
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 ...
Timing of Adjuvant Chemotherapy After Gastrectomy in Patients With Stage II to III Gastric Cancer: A Target Trial Emulation Study Master protocols represent transformations, enabling multiple ...
Introduction In 2021, globally, cardiometabolic diseases (CMDs) accounted for 35% of the 1.73 billion disability-adjusted life years (DALYs) attributed to non-communicable diseases. The Healthy Life ...
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according to a recent paper ...
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