
Feb 5
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.
This year’s SCOPE conference in Orlando kicked off with a keynote address from Janice Chang, CEO, TransCelerate Biopharma, and Mark McClellan, MD, PhD, director, Duke-Margolis Institute for Health Policy, Former Commissioner, FDA. Titled “Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There”, the duo discussed…
One major challenge facing the clinical research ecosystem is not whether, but how to study drug safety and efficacy in pregnant and breastfeeding populations. A growing number of organizations—including the ICH E21 Expert Working Group (EWG) and TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative—are diligently seeking ethical and responsible solutions to protect these…
The scientific community intended to protect pregnant and breastfeeding populations when it strictly limited their involvement in clinical trials after the thalidomide crisis of the 1950s-1960s. Yet over the past few decades, people have increasingly recognized the real-life challenges posed by the lack of research into the safety of medications used during pregnancy and breastfeeding.…