Protocol Design Featured Articles

  1. Is It Time To Replace RECIST — Or Just Add AI? 4/16/2026

    Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.

  2. What Really Moves The Needle In Primary Immunodeficiency Research And Treatment 4/14/2026

    Kedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.

  3. First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success 4/13/2026

    eGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.

  4. Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2) 4/10/2026

    In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.

  5. Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1) 4/10/2026

    Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.

  6. Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic 4/9/2026

    MimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection. 

  7. Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze At 4/8/2026

    Inimmune CEO David Burkhart explains how a GSK layoff led to the formation of a new company focused on treating allergic rhinitis. Here, he shares success from the company's approach to site selection, trial design, and timing.

  8. Redefining Patient Outcomes Measurement Using RWE Data 4/7/2026

    Discover an outcome-channeling framework that organizes patient outcomes into multidimensional domains, emphasizing longitudinal trajectories rather than single time endpoints.

  9. With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout 4/3/2026

    Crystallis President and CEO James Mackay shares insights from the company’s clinical decision-making for dotinurad, including the inclusion of an open label extension. 

  10. RWD Helps Researchers Include More Patients In Lymphoma Research 4/2/2026

    Andrew Evens, DO, MBA, explores how outcomes research and collaboration across academic networks, registries, and industry partners are advancing more inclusive, data-informed approaches to lymphoma research.