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One Pivotal Trial for FDA Approval? Success Depends on Trial Design
One pivotal trial for FDA approval could accelerate drug development, reshape clinical trial strategy, and change the pharmaceutical regulatory landscape.
FAST-EU Pilot: Can Europe Finally Accelerate Multinational Clinical Trials?
The FAST-EU Pilot aims to accelerate multinational clinical trials through faster coordinated assessments, supporting Europe’s 2030 clinical research ambitions.
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.
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.
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