Protocol Expansion Broadens Phase 3 HERO Trial Eligibility Criteria to Include Children Ages 7+ in the United States ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
A Swiss startup called Risklick has launched artificial intelligence software for clinical trials that the company claims can reduce development time and costs by as much as 35%, according to an April ...
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 ...
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 ...
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 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 ...
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 ...
Raja Shankar, VP of machine learning at IQVIA, discusses which AI capabilities sponsors are most likely to adopt first to ...
The real “commercial launch” happens years before launch preparation officially begins. Once Phase III begins, your evidence ...
When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...