The Pragmatic Trial Has Been Hijacked. Here Is What It Was Actually Supposed to Do.
JAMA's 2026 editorial exposes how "pragmatic trial" has been stretched beyond recognition, threatening regulatory credibility and real-world evidence quality.
Lancet Psychiatry’s CYP2D6 Venlafaxine Cohort Data Signals a Pre-Emptive Genotyping Inflection Point for CNS Trial Design
A dual-cohort Lancet Psychiatry study links CYP2D6 poor metabolizer status to venlafaxine treatment failure, pressing sponsors to rethink IND...
The VIRAGE Trial Cracked the Pancreatic Cancer Wall. Now the Hard Question Is Whether the Field Can Read the Blueprint.
VCN-01 plus gemcitabine/nab-paclitaxel improved OS in metastatic pancreatic cancer. The VIRAGE Phase 2b design shows what rigorous endpoint selection...
Platform Trials Are Rewriting the Rules of Evidence. Regulators Haven’t Caught Up.
Adaptive platform trials like REMAP-CAP enrolled 4,869 critically ill COVID patients across 300+ sites, but FDA's master protocol guidance...
Platform Trials Are Rewriting the Rules of Evidence Generation. Regulators Haven’t Caught Up.
Adaptive platform trials like RECOVERY and REMAP-CAP are transforming infectious disease research, but FDA and EMA guidance still lags...
FDA’s 2026 Single-Trial Default Standard Reframes the Dual-Pivotal Debate for Sponsors Still Designing Phase 3
FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3...
The Liquid Biopsy That Found Pancreatic Cancer Early Has a Bigger Regulatory Problem Than Its Science
PANXEON detects stage 1-2 pancreatic cancer with 87% sensitivity, but FDA's companion diagnostic pathway may be the bigger obstacle...
Benchmark Scores Don’t Save Patients: Why Clinical AI Needs RCT-Grade Evidence Before It Touches a Workflow
Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...
What FDA’s July 2026 Psychedelic Drug Guidance Actually Says About Trial Design
FDA's finalized psychedelic guidance rewrites the rules on blinding, informed consent, and session monitoring, and the NEJM's September 2026...
DYNAMIKA™: The Operating System for Imaging Clinical Trials
Sponsored by Image Analysis Group. Why the imaging platform decision is the single most consequential infrastructure choice a sponsor...