Protocol Design Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It 12/9/2025

    Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.

  5. Overcoming Cell Therapy Design Challenges To Treat AML And Other Life-Threatening Diseases 12/9/2025

    CERo CEO Chris Ehrlich discusses how a focus on safety, robust manufacturing, and key early indicators is rewriting the playbook for future personalized medicine trials.

  6. Navigating The Challenges Of Cell Therapy Clinical Trials 12/5/2025

    IN8bio CEO William Ho shares how they overcame operational challenges unique to cell therapy research, including how to carefully conduct site expansion and onboard new sites without disrupting study timelines.

  7. Patient Input Is A Must — Even Under Time And Money Constraints 12/4/2025

    Stacie J. Bell, PhD, chief clinical research officer of Lupus Therapeutics, discusses the positive impacts patient advocacy groups can have on patient recruitment, patient retention, protocol design, and more.

  8. Digital Biomarkers Are Reshaping Alzheimer's Patient Experience And Data 11/26/2025

    Cognito CEO Christian Howell shares how EEG and digital biomarkers are reshaping recruitment, patient experience, and the quality of study data in Alzheimer’s research.

  9. Non-Invasive Brain-Computer Interface Trial Balances Regulatory Requirements With Patient Needs 11/13/2025

    Cognixion CTO Chris Ullrich introduces the Axon-R Nucleus bio-sensing hub and discusses its feasibility trial, highlighting the importance of patient input, caregiver quality of life, and regulatory support. 

  10. Sponsors Collect Too Much "Non-Essential" Data, Say Tufts And TransCelerate 11/6/2025

    A collaboration between Tufts CSDD, Tufts School of Medicine, and TransCelereate BioPharma revealed just how much extra data sponsors are collecting — and why that's a problem.