Protocol Design Featured Articles

  1. Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites 1/27/2026

    Incomplete protocols, lengthy sponsor decision timelines, and uncompensated work plague clinical research sites. Learn why these issues exist and how to address them alongside experts from SCRS and Tufts CSDD.

  2. The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk 1/22/2026

    When it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.

  3. Endpoints, Procedures, And Deviations Are On The Rise — Why? 1/20/2026

    SCRS Chief Site Success Officer Jimmy Bechtel, MBA, and Tufts CSDD Executive Director Ken Getz, MBA, discuss why they're on the rise explore ways to address, and even accept, them. 

  4. Confronting "Time Toxicity" In Global Oncology And Rare Disease Trials For Operational Excellence And Patient Retention 1/14/2026

    Time is the only truly finite resource in a clinical trial. Consultant Leila Cupersmith discusses how sponsors can better design trials with a lower time burden to boost enrollment, retention, and overall operational excellence.

  5. 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. 

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.