Applied Clinical Trials

In today’s ACT Brief, we examine why APAC inspection findings mirror those in the US and Europe, how key risk indicators should be read together, and how FDA granted accelerated approval to a subcutaneous antibody therapy for recurrent head and neck cancer.

In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the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

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.

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.

In today’s ACT Brief, we examine why community research needs lasting financing and infrastructure, how electronic outcome tools can strengthen neuroscience endpoints, and how Teva is licensing two biosimilars from Samsung Bioepis.

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lack access to research as a care option, what makes AI assistants trustworthy in regulated trials, and how FDA draft guidance could let gene editing therapies cover patient-specific variants.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.