As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Protocol teams can invest months in expert review and still face costly amendments, frozen enrollment and delayed Phase III ...

Generative AI is streamlining the creation of clinical trial protocols, cutting drafting time from weeks to hours while improving accuracy and regulatory alignment. By automating routine sections and ...

While important, clinical trial protocols merely provide the foundation for success. It is the people who run those protocols, and their use of optimal processes and systems, that determine whether ...

A new research perspective was published in Volume 13 of Oncoscience on March 11, 2026, titled "Early success of the COCOON trial: Preventing dermatologic adverse events in first-line EGFR-mutant ...

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 ...

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 ...

Introduction Suicidal ideation is common in young people and increases the risk of suicide. Effective interventions that are relevant and accessible to young people, so-called digital natives, are ...

Valion Bio, Inc. (Nasdaq: VBIO) (formerly Tivic Health Systems, Inc.), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care ...

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 ...

LUCENT-3 trial open-label extension data show 63.5% of adults with ulcerative colitis administered mirikizumab (Omvoh) who ...