Jun 4
Clinical research has never been more capable of reaching new frontiers. The science is here. The technology is here. But the approach to trial design and execution hasn’t kept pace. The clinical research ecosystem proceeds cautiously for good reasons—patient safety chief among them. But too often, we’re held back by fixed mindsets and outdated processes. The result? A growing disconnect between what’s possible in theory and what’s delivered in practice.
Read the full article by Allison Cuff Shimooka from Applied Clinical Trials 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…