Applied Clinical Trials Digital Edition - August 2012

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how FDA inspection findings at APAC sites compare with those in the US and Europe, and why the common issues, such as informed consent versioning, are not unique to the region.

In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the FDA on a pivotal gene therapy trial design.

Risk-based quality management depends on knowing what to monitor and on interpreting what the signals mean.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how regulatory reform and inspection data contradict the view that APAC sites are slower or lower quality, and why sponsors need to update their assumptions.

In this Q&A, Kent Thoelke, CEO of Paradigm Health, discusses why participation gaps in community and rural settings come down to both patient cost barriers and site infrastructure, how legacy workflows weigh on community clinics, and what policy and technology changes it would take to make clinical research a real care option for more patients.

In today’s ACT Brief, we examine how capturing friction in real time can reveal site burden, how OpenAI and Mistral compare on clinical trial matching, and how Boehringer Ingelheim is licensing early-stage oncology programs from SBP Group.

Mistral and OpenAI produced identical overall eligibility labels across 200 synthetic patient-study assessments, with criterion-level disagreements concentrated in inclusion criteria where models switch between “Uncertain” and “Not included” when records lack sufficient evidence, so model choice should be driven by deployment architecture, control, and cost rather than assumed interchangeability.

In Episode 4 of The Human Side of Clinical Trials, host Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., speaks with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about how capturing friction closer to the moment it happens can reveal unclear instructions, technology friction, and workarounds that retrospective surveys and debriefs tend to miss.