Applied Clinical Trials

In today’s ACT Brief, we examine what changes when AI is embedded across clinical operations, why faster trial data isn’t yet producing faster decisions, and how FDA granted accelerated approval to a therapy for a rare airway disease.

In today’s ACT Brief, we examine what policy changes would help community and rural institutions join research, how Walmart is expanding clinical trial centers into three more states, and how FDA approved Ilumya for adults with active psoriatic arthritis.

In today’s ACT Brief, we examine why community and rural patients lack access to research as a care option, what makes AI assistants trustworthy in regulated trials, and how FDA draft guidance could let gene editing therapies cover patient-specific variants.

In today’s ACT Brief, we examine why anti-kickback guidance and EHR-integrated trial matching must work together in community settings, why real-time trials depend on mature risk-based quality management, and how pharma is applying digital clones to predict outcomes.

In today’s ACT Brief, we examine how legacy workflows pull community clinics away from patient care, why medical writing capacity depends on training rather than technology, and how an antiviral aims to prevent COVID-19 after exposure.

In today’s ACT Brief, we examine how cost barriers and site infrastructure limit participation in community trials, why endpoints should reflect what patients actually experience, and how the FDA expanded a prostate cancer combination to an earlier treatment setting.

In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate eSource-enabled workflows, and what a bipartisan bill proposes for reusable trial networks.

In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.

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.

Can artificial intelligence help turn what many believe is clinical development’s biggest variable — and most prevailing bottleneck — into a more predictable process? In this episode of the Applied Clinical Trials podcast, Matt Walz, CEO of Trialbee, a patient recruitment company, joins Mike Christel, group managing editor, MJH Life Sciences, to discuss how AI is enhancing medical screening, clinical workflows, and enrollment planning. The conversation explores the need for clearer regulatory expectations, human oversight, and workforce training — and why predicting enrollment costs and timelines, Walz believes, could offer one of AI’s most consequential opportunities in clinical trials.

Walz also shares how Trialbee is deploying AI on both the patient-facing and operational sides of its business and explains how conversational tools are helping teams move from the world of dashboards to more specific answers.

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 FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.

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.