Nicole (BSc Molecular Medicine, Honours Medical Biochemistry) has many years of pharmaceutical experience, having worked for top CROs and biopharma companies for more than a decade.
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 clinical trial oversight is intensifying globally as the agency raises expectations for GCP, foreign site inspections, data integrity, and patient protection.
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.