As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Recommendations for Interventional Trials (SPIRIT) 2025 guidelines published in The Lancet and commend the efforts to enhance transparency and rigour in clinical trial protocols.1,2 Accurate and ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

Correspondence to Dr Thomas Bandholm, Dept of Clinical Research, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre DK-2650, Denmark; thomas.quaade.bandholm{at}regionh.dk The REPORT guide ...

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The companies behind three major COVID-19 vaccines in development released the protocols of their ...

To better recognise its potential to address the challenge of white space in clinical trials, it helps to first understand ...