Despite being a cornerstone of cancer treatment advancement, clinical trials remain inaccessible for many patients because of structural, socioeconomic, and systemic barriers. In this ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Veristat has announced its intended acquisition of Certara's Regulatory and Medical Writing business, a move that will add ...

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 ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

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 ...

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 ...

This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from ...