As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
Insufficient physical activity (PA) among children has become a major global public health concern. The family environment ...
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 ...
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 ...
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 ...
Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...
Survival-inferred fragility index of FDA-approved cancer drugs using surrogate endpoints. Trends in U.S and global patient enrollment from 2014 to 2022 in lung cancer clinical trials supporting ...
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 ...
The U.S. is giving $1.6 million to researchers to study how the hepatitis B vaccine affects newborns in Guinea-Bissau. Local ...
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