The future of clinical research depends on people just as much as strong systems and processes. Learn what makes great ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
The U.S. is giving $1.6 million to researchers to study how the hepatitis B vaccine affects newborns in Guinea-Bissau. Local ...
In this free webinar, understand the key benefits of master protocols. Attendees will identify the key challenges of master protocols and strategies to address them. The featured speakers will discuss ...
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...
Officials at the US Department of Health and Human Services, which awarded funding for the controversial study, say it will ...
Central retinal artery occlusion can result in permanent vision loss. Effective treatment is lacking. We conducted a phase 3, double-blind, double-dummy, randomized, controlled trial involving ...
Roughly 70 to 80% of ovarian cancer cases are diagnosed at an advanced stage, 1 where treatment options are limited and eligibility criteria for clinical trial participation become more difficult to ...
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 ...
A clinical trial protocol is the foundation of clinical research, detailing objectives, study design, eligibility, safety oversight, and data analysis. Its structure ensures consistency and ...
A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. As BioXcel unveiled its phase 3 data ...
The integration of real-world data (RWD) into protocol feasibility and site selection has emerged as a clinical trial game-changer in recent years. Traditionally relying heavily on data from carefully ...
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