
Metrics & Benchmarks
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What "Patient Voice" Actually Requires: Beyond the Buzzword

Lessons from Hundreds of Clinical Trials: AI’s Successes, Gaps, and Opportunities

ACT Brief: Expedited IND Pilot Launch, Operating Model Importance, and Readiness Prediction

FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines

Benchmarking Study Finds Clinical Trial Performance Is Shaped by Operating Model Design, Not Sourcing Strategy

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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.

As the life sciences industry continues to evolve, the ability to effectively manage and leverage preclinical CRO partnerships is set to become a defining characteristic of successful biopharma companies.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, shares what she has learned firsthand from families living with Dravet syndrome and CDKL5 deficiency disorder about what makes trial participation possible—and what makes it not.

In today's ACT Brief, we examine how shifting patient engagement to endpoint selection improves trial data quality, why execution infrastructure must precede AI deployment, and addressing missing baseline data in real-world oncology research.

Clinical trials have spent decades perfecting data capture, but the execution layer underneath it, including decision workflows, data collection design, and lab connectivity, remains fragmented in ways that limit what AI can realistically deliver and that quietly compromise the scientific validity of the data itself.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, describes how shifting patient engagement from protocol review to endpoint selection transforms both the quality of trial data and the experience of participation.

In today's ACT Brief, we examine why seizure reduction misses what families want from epilepsy trials, how lab coordination requires connecting data to intent, and why healthcare needs orchestration rather than more tools.

True lab orchestration isn't about coordinating instruments, it's about connecting scientific intent, data, and decisions across the entire research lifecycle.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, explains why the full burden of developmental and epileptic encephalopathies extends far beyond clinical symptoms—and why endpoints must reflect what families are actually hoping for.

In today's ACT Brief, we examine genuine patient partnership in trial design, how AI enables informed recruitment while preserving clinician relationships, and moving patient engagement beyond performative gestures.

In this Q&A, John Worden, chief commercial officer at Javara, discusses why clinical trial recruitment has remained stubbornly one-size-fits-all, how AI can identify patients at scale without displacing the clinician relationships that drive trust, and what care-integrated research engagement needs to look like for health systems, sponsors, and sites.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, explains why genuine patient partnership begins before the protocol is written—and what it looks like when patients and caregivers tell you a trial was designed with them in mind.






















