FEATURED ARTICLES
5 Critical Risks With The FDA's Real-Time Trial Monitoring
Life science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.
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ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity
Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.
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Clinical Failures Persist Because They're Structural, Not Random
Clinical failures are no longer contained within a single program but happen across portfolios, companies, and therapeutic areas. Advisor Mikail Evteev suggests the reason is a failure to learn from past mistakes.
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Breaking Barriers In Rare Disease Clinical Trials
Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.