A weekly doctor-insider briefing on the five signals that matter in clinical trials: one global standards shift, one FDA update, one EMA update, one safety signal, and one event or industry move.
Clinical Trials Brief is an educational commentary archive, not a real-time news service. Confirmed facts are based on publicly cited sources where possible. Analytical comments, comparisons, and forward-looking views are personal interpretation unless otherwise stated. Demo entries are for layout testing only and should not be treated as verified reporting.
This week: FDA's parallel overhaul of both trial monitoring and internal review infrastructure through AI, a rare cancer drug reconsideration that tests where the evidence bar is moving, new detail on the practical fallout of OpenEvidence's EU exit, a joint FDA-industry rethink of how safety data is collected in trials, and a UK-led colorectal cancer trial reporting zero relapses at nearly three years with immunotherapy before surgery.
This week: FDA launches real-time clinical trial monitoring with AstraZeneca and Amgen, proposes withdrawing Tavneos after discovering pivotal trial data manipulation, a $12 billion clinical AI platform exits Europe over the EU AI Act, a Nature-published trial shows how to cut checkpoint combination toxicity by 60%, and Intellia reports the first positive Phase 3 for in vivo CRISPR gene editing.
Read issueThis week: a wave of billion-dollar pharma-AI enterprise deals, an FDA filing acceptance that could bring the first anti-CD20 therapy for lupus, a strong CHMP month with five new medicines recommended including a first-in-class BTK inhibitor for progressive MS, a GLP-1 side-effect story generating its own clinical trials, and a cluster of positive Phase 3 late-breakers from AAN 2026.
Read issueThis week: FDA's transparency crackdown on unreported trial results, new draft guidance on genome editing safety assessment, a PRAC safety action on the epilepsy drug Ontozry, post-marketing safety requirements for Lilly's obesity pill Foundayo, and two independent pancreatic cancer trials reporting doubled survival.
Read issueThis week: a major proposed cut to NIH funding, FDA's broader shift toward flexible evidence standards, EMA's tailored biosimilar evidence model, a more practical read on how real-world data is actually being used in trials, and a reported Lilly-Insilico deal that keeps AI drug discovery firmly on the strategic agenda.
Read issueThis week: EU guidance for emergency trial activation, FDA and EMA both streamlining biosimilar evidence requirements, a broadened Ixchiq safety profile, and a Tempus-Daiichi Sankyo AI collaboration focused on biomarker discovery.
Read issueThis week: safety-data standards move further into implementation, FDA sharpens the path for non-animal testing methods, EMA links CTIS upgrades to competitiveness, PRAC updates the Ixchiq risk picture, and Tempus-Merck shows where biomarker AI is heading next.
Read issueLinkedIn is used for discovery. Commentary is grounded in official, primary, or directly attributable sources whenever possible.