Protocol Design Featured Articles

  1. Working (Well) With Patient Advocates: The Sponsor POV 1/12/2026

    Aeovian CEO Allison Hulme reflects on Aeovian Pharmaceuticals' partnership with the TSC Alliance and how it’s informed research and development of their first-in-class selective mTORC1 inhibitor. 

  2. Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit 1/12/2026

    Opus Genetics CEO George Magrath, MD, discusses how the company introduced virtual reality-enabled assessments and relied on digital endpoints to better measure participants’ vision changes.

  3. Working (Successfully) With Pharma: A PAG's Perspective 1/12/2026

    TSC Alliance President and CEO Kari Rosbeck details the patient advocacy group's unique and fruitful relationship with Aeovian Pharmaceuticals in developing the company's first-in-class selective mTORC1 inhibitor for TSC-related refractory epilepsy.

  4. 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.

  5. 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.

  6. 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.

  7. 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.”

  8. 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.

  9. 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.

  10. 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.