As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

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 ...

Impact of the integration of remote clinical oncology pharmacists into routine precision medicine workflows on biomarker testing rates within The US Oncology Network community-based practices. This is ...

Please provide your email address to receive an email when new articles are posted on . Approximately 19% of clinical trials evaluated had primary endpoint changes detected. More than 70% did not ...

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 ...

Mild traumatic brain injury (mTBI) remains a significant health concern for the US Military Health System and a threat to warfighter readiness. Although most service members (SMs) recover following an ...

The evolution of clinical research has been dependent on the conversion of Healthcare Organizations (HCOs) to clinical research sites, along with the conversion of Healthcare Providers (HCPs) to ...

A large-scale clinical trial has determined that a specific brain stimulation device, previously cleared by regulators for ...