Protocol Design Featured Articles

  1. Making Medical Innovation Matter To Patients With Simplified Trial Design 1/9/2026

    To be a leader in today’s environment, Lexicon Pharmaceuticals CMO Craig Granowitz, MD, Ph.D., says companies must embrace simplified clinical trial designs, which can reduce regulatory risks, lower R&D costs, and shorten clinical timelines.

  2. How Should Scientific Focus Change In 2026? Researchers Weigh In 1/8/2026

    To kick off 2026, clinical researchers share how they think research should change in the new year.

  3. Researchers Want A Design Shake-Up In 2026 1/7/2026

    When asked what clinical research professionals should leave behind in 2025, quite a few lamented the stale, even problematic, approach to clinical trial design. Here's what they want done differently in 2026.

  4. No Surprise Here: Experts Value Clinical Relevance Over Statistical Relevance 12/31/2025

    Experts weighed in: “Agree or disagree? Statistical significance is preferable to clinical relevance.”

  5. FDA Further Expands And Clarifies Expanded Access FAQs 12/29/2025

    Healthcare attorney Dianne J. Bourque breaks down the FDA's October 2025 update to its Expanded Access FAQs.

  6. What Is Win Ratio, And How Can It Be Used In Rare Disease Research? 12/17/2025

    Amber Salzman, CEO of Epicrispr Biotechnologies, explains how applying the win ratio in facioscapulohumeral muscular dystrophy (FSHD) could transform the way researchers evaluate therapeutic impact, enhance statistical efficiency, and improve trial design.

  7. Adaptive Trial Design Is Changing Oncology And Hematology Clinical Trials 12/16/2025

    Pfizer Global Development Lead, Clinical Development Oncology & Hematology, Shreya Badhrinarayanan, MD, explains how adaptive trials, enriched by AI and better data integration, are transforming oncology and hematology clinical research.

  8. Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It 12/9/2025

    Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.

  9. Overcoming Cell Therapy Design Challenges To Treat AML And Other Life-Threatening Diseases 12/9/2025

    CERo CEO Chris Ehrlich discusses how a focus on safety, robust manufacturing, and key early indicators is rewriting the playbook for future personalized medicine trials.

  10. Navigating The Challenges Of Cell Therapy Clinical Trials 12/5/2025

    IN8bio CEO William Ho shares how they overcame operational challenges unique to cell therapy research, including how to carefully conduct site expansion and onboard new sites without disrupting study timelines.