FDA Oncology Trial Guidance Targets Eligibility Barriers
FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.
What Sponsors Need to Know About UK Combined Review 2026
UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.
FDA Clinical Trial Oversight Tightens Globally
FDA clinical trial oversight is intensifying globally as the agency raises expectations for GCP, foreign site inspections, data integrity, and patient protection.
MHRA Updates GCP Inspection Guidance for ICH E6(R3)
The MHRA GCP inspection guidance now reflects ICH E6(R3) and the UK’s 2026 trials reform, with a new computerised systems dossier and clear TMF access rules.
How Low Can They Go? Clinical Trial Success Rates
Clinical trial success rates have declined sharply over the past 20 years. This analysis examines what the data reveals about the drug approval rate and phase-by-phase attrition.
11 Clinical Trials Defining Pharmaceutical Strategy in 2026
We've mapped the competitive, regulatory, and commercial stakes of the top 11 clinical trials that have defined pharma strategy so far in 2026.