Protocol Design Featured Articles

1. 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.

2. 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. 

3. 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.

4. 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.

5. 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.

6. 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. 

7. 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.

8. 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.

9. 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.

10. 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.”