As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...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 ...

Anonymous survey with optional confidential interviews will document how practitioners facilitate MDMA-assisted couples ...

Beyond the design, if enrollment slows due to seasonal effects or difficulty finding a niche patient group, a robust design activates a contingency plan that dynamically adjusts site selection based ...

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 ...

The real “commercial launch” happens years before launch preparation officially begins. Once Phase III begins, your evidence ...

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 ...

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 ...

PhaseV, a leader in AI/ML for clinical development, today announced the launch of its new Enrollment Lab solution at the 17th ...

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 ...