
Sep 30
Released at the start of 2025, the ICH-E6(R3) guideline is an updated international standard for how clinical trials should be designed, conducted, recorded, and reported. At its core, the guideline ensures that people who participate in clinical trials are kept safe and that the data collected is reliable and meaningful. This guideline is not a set of rigid rules, but rather it introduces clear principles that allow researchers and sponsors to make thoughtful, risk-based decisions tailored to each study’s specific needs.
Read the full article by The Medicine Maker here.
At the 2025 SCOPE Summit Conference, industry leaders gathered to discuss the integration of real-world data (RWD) into clinical trials and practice. The panel, featuring Robert DiCicco from TransCelerate Biopharma, Su Chen from MITRE Corp, Jesper Kjaer from Novo Nordisk, Trevan Locke from Duke University, and Chris Decker from CDISC, explored the complexities and opportunities…
ICH-E6(R3) represents a shift in mindset when it comes to clinical trials. Rather than trying to control every part of a trial equally, the guideline wants researchers to focus most on factors that are critical to participant safety and the reliability of trial results. It introduces the idea of “proportionality,” meaning more control is applied…
Getz, the Executive Director at the Tufts Center for the Study of Drug Development (CSDD), presented findings from a study they did with TransCelerate BioPharma, which sheds light on the volume and purpose of data collected in clinical trial protocols. His talk centered on a fundamental paradox in modern clinical research: While we have an…