Industry Insights

  1. Age Diversity In Clinical Trials: Considerations For Improving Older Adult Representation 9/30/2025

    Without prioritizing age diversity in recruitment and enrollment, research findings aren’t fully generalizable to this key demographic, limiting the applicability of trials. Let's look at what drug sponsors can do.

  2. Pediatric Clinical Trials Must Approach Research With Today's And Tomorrow's Kids In Mind 9/30/2025

    Phoenix Children’s SVP of Research Stewart Goldman, MD, describes their patient-centric approach, offering insights into patient selection and education, as well as trial design.

  3. GCP Oversight Simplified: A Quick Guide 9/29/2025

    Discover practical, real-world strategies for sponsors to operationalize GCP oversight in a way that is collaborative, measurable, and scalable.

  4. Powering Standards With Code: The Role Of Open Source In CDISC 360i 9/26/2025

    Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

  5. Site-Level Change Model And Successful Strategies For Medicare Compliance In Clinical Trials 9/26/2025

    Discover best practices for achieving and maintaining Medicare billing compliance for clinical trials.

  6. Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM) 9/25/2025

    The Bayesian Logistic Regression Model (BLRM) is redefining Phase I clinical trial design by bringing flexibility, precision, and patient-centered safety into early drug development.

  7. 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.

  8. 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.

  9. 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.

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 FDA Draft Guidance On Overall Survival in Oncology Trials 9/25/2025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