Mar 17
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 in leveraging RWD for healthcare advancements.
Read the full article from Clinical Trial Vanguard here.
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…
Clinical trials are a key tool for producing the safety and efficacy data that guide new therapies to market. Progress in clinical research relies on those who volunteer to participate, and yet, access to trials is not the same for everyone in the United States. Read the full article featuring Allison Cuff Shimooka from TechTarget…
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…