Sep 25
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 to high-risk areas. It also acknowledges that technology plays a major role in today’s research, and outlines expectations for using digital systems responsibly.
Read the full article by The Medicine Maker here.
Related Blog Posts
Why Protocol Complexity Keeps Increasing – and How to Fix It
We’ve been discussing simplifying protocol designs for decades. And yet, a phase III protocol today collects nearly 6 million data points on average; a figure that’s been climbing by roughly 11% annually. Read the full article from MedCity News here.
Making AI work where it matters, with Rob DiCicco
In a new pharmaphorum podcast, web editor Nicole Raleigh was joined by Rob DiCicco, vice president of portfolio management at Transcelerate Biopharma Inc, for a conversation on the barriers and the breakthroughs in making AI work in drug development and clinical trials. Read the full article featuring Rob DiCicco from Pharmaphorum here.
From Vision to Value: A Blueprint for Implementing Industry Consortia Innovations
Our healthcare landscape is rapidly evolving and presenting us with complex challenges: modernizing clinical trials, ethically integrating artificial intelligence, and delivering patient-centric care. No single organization can tackle these issues alone. Read the full article from DIA Global Forum here.