When Phase 3 Fails Because of Trial Design, Someone Missed a Signal Months Earlier
AstraZeneca's HICKORY trial missed its primary endpoint not because efzimfotase alfa didn't work, but because the trial design did,...
Phage Therapy Trials Are Launching Without a Regulatory Playbook. That’s a Problem.
Phage therapy trials for drug-resistant UTIs are advancing with no FDA guidance document, here's why comparator selection and resistance...
Sponsors Should Match Outsourcing Model to Development Strategy, Not Vice Versa
Sponsors must align outsourcing model to development strategy, not vice versa, as new regulatory pathways require faster adaptation.
AI Adoption in Clinical Trials Hindered by Validation, Governance Gaps
AI adoption in clinical trials faces validation and governance gaps, not technical doubts. Organizations need process infrastructure and proper...
Tegoprazan Meets Primary Endpoint in Phase 3 NERD Trial
Tegoprazan Phase 3 NERD trial met primary endpoint, showing 74% relative increase in heartburn-free days over placebo at 100...
How 3 Converging Waves (Not Just AI) are Transforming Clinical Data.
The clinical data world has been promised transformation before. With advancements like eSource, risk-based monitoring, and paperless trials, each...
Replication Is Dead. Corroboration Is the Standard Clinical Trials Must Meet Now.
The NEJM just reframed reproducibility in biomedical science, and every clinical trial sponsor still designing for repetition is building...
Advarra funds PRIM&R AI ethics curriculum for research oversight
Advarra funds PRIM&R AI ethics curriculum for research oversight. IRBs gain guidance on algorithm governance and AI tool evaluation...
Neurology Trial Sites Take 167 Days to Activate, Delaying Enrollment
Neurology trial sites take 167 days to activate on average, causing enrollment delays and pushing Phase III programs millions...
Joint Commission Awards UPMC for Genomic Surveillance Program
Joint Commission awards UPMC's Genomic Surveillance Program for detecting hospital bacterial transmission events missed by conventional infection surveillance m