Clinical Guest Contributors

  1. FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs 3/4/2026

    The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.

  2. Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial 3/3/2026

    Discover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.

  3. The Uncomfortable Conversation: AI And Data Use In Clinical Trials 3/2/2026

    AI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.

  4. When A Clinical Trial Surfaces In An AI Chat, What Happens Next? 3/2/2026

    AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.

  5. The Cost Of Transactional Thinking In Clinical Research 2/26/2026

    Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.

  6. Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1) 2/25/2026

    Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.

  7. Safe And Sustainable DCTs and Hybrid Trials (Part 2) 2/25/2026

    In part two of this series, learn practical cloud architectural patterns, governance structures, and operating mechanisms that allow sponsors to run hybrid and decentralized trials.

  8. Why Sponsors Should Share KPI Rationale With Sites 2/25/2026

    To build partnerships, foster transparency, and promote shared accountability, Curo Research CEO Amy Bland explains why sponsors need to communicate the utility of KPIs with sites.

  9. Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial 2/24/2026

    Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).

  10. Breaking Through Tumor Defenses With Next-Generation Cell Therapy 2/20/2026

    Ernexa Therapeutics CEO Sanjeev Luther shares how clinical research has revealed why certain cancers resist treatment and how emerging cell therapies may help break through those defenses.