Mar 4
03/07/2025
Clinical trials that support the development of new and innovative therapies and healthcare delivery are fundamentally supported by separate infrastructures, processes, and objectives. This comes with unique sets of capabilities, staffing, regulations, data platform systems, and incentives. But patients could be better served by a future that breaks with the status quo and unlocks the power of data to answer regulatory questions and inform clinical practice.
Read the full article by Rob DiCicco from Clinical Leader here.
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…
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…