Modern Approaches and Considerations for Designing Real-World Studies

Why clinical development’s next AI bottleneck is not the model, but the system around it.

In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.

The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.

A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.

Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.

This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, outlines what it takes to move beyond transactional engagement and treat patient advocacy organizations as long-term partners in the science and the care.

In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.