Protocol Design Featured Articles

  1. i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned 7/2/2026

    Discover how well AI fared in document generation, patient engagement, data integration, and more in an end-to-end proof-of-concept study run by i-Cubed.

  2. How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa 6/30/2026

    Elisa Maggioli, Ph.D., explains that improving outcomes in HS may depend on moving beyond broad, symptom-based approaches toward more targeted, biologically informed strategies.

  3. Unicycive Therapeutics' Framework For Speedier Clinical Trials 6/29/2026

    Unicycive Therapeutics Vice President of R&D Guru Reddy, Ph.D., shares how his small team moved swiftly through a recent early phase trial.

  4. Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder 6/26/2026

    Helus Pharma CMO Amir Inamdar discusses the strategic rationale behind its Phase 3 trial for major depressive disorder, including its adjunctive-treatment approach, patient population selection, and endpoint strategy.

  5. RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short 6/25/2026

    Chiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.

  6. AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them 6/25/2026

    AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?

  7. Where Are We With Clinical Trial Tokenization? 6/19/2026

    In January 2024, I interviewed Tom Dougherty about a topic many clinical research professionals had heard mentioned but few could confidently explain: tokenization. I wanted to get caught up on any progress that has been made, so I completed this Q&A with Dougherty, who is Real-World Data Strategy Director, CMR - Clinical Data Science & Evidence at Novo Nordisk.

  8. To Prevent Parkinson's Disease, We Need New Biomarkers 6/16/2026

    Parkinson's disease research has shifted toward prevention and prodromal intervention but success with disease-modifying and preventive therapies depends on validated PD-specific biomarkers. AC Immune Cofounder and CEO Andrea Pfeifer explains.

  9. Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension 6/10/2026

    Cereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.

  10. New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA 6/9/2026

    NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.