As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...

Together, Risklick and Citeline deliver an integrated, intelligent protocol development experience that combines smart ...

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 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 ...

Vielight Neuro RX Gamma device and irradiation configuration used in the randomized, double-blind, sham-controlled trial. The ...

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 ...

Industry experts have provided insight into how oncology clinical trials can be designed for success from the outset and rendered as patient-centric as possible. At the Clinical Trials in Oncology ...

Clinical trials continue to be a driving force in ophthalmology, propelling the development of innovative treatments and ...