Editorial Podcasts

In today’s ACT Brief, we examine how AI is moving into continuous clinical operating models, how trust is built into oncology real-world evidence, and how the FDA approved a self-administered option for thyroid eye disease.

In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.

In Episode 3 of The Human Side of Clinical Trials, hosts Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., speak with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about why a well-written protocol doesn’t always translate into consistent execution, and how designing for the way people actually think and learn can reduce site burden and the need for costly unlearning.

In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.

In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.

Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.

In today's ACT Brief, we examine proportionate analysis frequency in RBQM, how to build trust into real-world evidence foundations for cancer trials, and how rare disease developers monetize regulatory success.

In today's ACT Brief, we examine how AI surfaces design flaws before enrollment, why site training readiness depends on learning science, and the priorities defining next-generation weight-loss therapies.

In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.

In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.

In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.

In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.

In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.

In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.

In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.

In today's ACT Brief, we examine what patient-site relationships need beyond easier technology, how to build defensible rare disease evidence from scratch, and how real-world data and AI improve enrollment screening accuracy.

In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.

In today's ACT Brief, we examine understanding the patient journey from end to end, whether decentralization reduces site burden or just shifts it, and why nine European drugmakers are sounding urgent alarms.

In today's ACT Brief, we examine technology's real role in patient-site collaboration, why AI pilot failures stem from organization not innovation, and Novo's weight-loss drug results in competitive comparison.

In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a gene therapy for a rare childhood syndrome.

In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.

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.

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 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.

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.

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.

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.