Insights on Clinical Trials

  1. Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) 9/25/2025

    The benefits are clear: CRM accelerates dose finding, reduces patient exposure to unsafe doses, and improves trial efficiency.

  2. Effect Of Etrasimod On Immune Cell Subsets In Colonic Tissue 9/25/2025

    Etrasimod selectively modulates S1P receptors to reduce inflammation and immune cell trafficking to the gut, showing promise in treating moderate to severe ulcerative colitis.

  3. Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM, And Modern Adaptive Strategies 9/25/2025

    As precision medicine evolves, trial designs must increasingly accommodate personalized therapies, adaptive strategies, and AI-driven modeling.

  4. Conducting Autologous Cell Therapy Research With Zero Sample Loss 9/25/2025

    Autologous cell therapy trials require precision at every stage—and this biomarker-specific solid tumor study exemplified the challenge.

  5. FDA Draft Guidance On Overall Survival in Oncology Trials 9/25/2025

    Historically regarded as the gold standard efficacy endpoint, Overall Survival (OS) in oncology trials is now positioned not only as a measure of therapeutic benefit but also as a critical safety endpoint.

  6. Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success 9/24/2025

    The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.

  7. Decentralized And Community-Based Solutions Driving Women's Healthcare 9/24/2025

    Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.

  8. Redefining Accessibility For Pediatric Patients 9/24/2025

    Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.

  9. Community-Focused Site Networks Increase Access And Trial Reach 9/23/2025

    Community-based site networks enhance clinical trial equity by engaging diverse populations, improving enrollment, retention, and developing therapies effective across varied patient groups.

  10. 5 Proven Ways To Expand Clinical Trial Site Capacity 9/18/2025

    How can you turn capacity limits into enrollment momentum and ensure timelines stay on track while also expanding access to diverse patient populations?