Protocol Design Featured Articles

  1. New FDA Program Adds Flexibility For Ultra-Rare Disease Submissions 9/23/2025

    Life science legal experts Mark A. Tobolowsky and Frank J. Sasinowski discuss the FDA's new Rare Disease Evidence Principles (RDEP) initiative.

  2. 3 Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial 9/23/2025

    Discover how non-profit partnerships, adaptive trial design, and real-world evidence can all play a part in helping biotech's successfully launch their first-in-human trial.

  3. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

    Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

  4. 4 Steps To Make A Business Case For Digital Endpoints 9/12/2025

    Anita Burrell explains how to build a business case for including digital endpoints and the elements to consider.

  5. Are Pragmatic Trials The Patient Recruitment Solution We've Been Looking For? 9/9/2025

    TransCelerate's Rob DiCicco reintroduces the "pragmatic trial" design concept, discusses its potential benefits, and provides resources for its integration.

  6. Redesigning Oncology Trials Around Tumor Vulnerability: The Rise of WEE1 And DDR Strategies 9/8/2025

    As clinical progress with DNA damage response (DDR) continues to evolve, research must respond with adaptive models, smarter combinations, and biomarker-informed patient selection.

  7. Alzheimer's Trial Targeting Amyloid Beta Oligomers Sees Cost Savings, Patient Satisfaction With New Screening 8/29/2025

    Acumen Pharmaceuticals' Eric Siemers, MD, discusses their novel Alzheimer's disease screening method and trial design for investigational drug sabirnetug that keeps both the clinical site and patient experience in mind. 

  8. 3 Quick Takes From A PI With 100+ Trials To His Name 8/29/2025

    Principal investigator Norman B. Gaylis, MD, shares his perspective on patient recruitment, protocol design, and vendor selection.

  9. Why More Biotechs Are Starting Trials In Australia 8/27/2025

    Why are so many U.S. biotechs heading to Australia for their first-in-human trials? Speed, cost, and simplicity. In our latest piece, Megan Robertson and Tina Soulis break down how sponsors can move from protocol to first patient in just a few months—while saving money and generating data regulators will accept worldwide.

  10. J&J Taps Tau-Based Diagnostics To Improve Alzheimer's Disease Trial Design And Enrollment 7/31/2025

    Johnson & Johnson's Fiona Elwood, Ph.D., discusses the potential of tau-based diagnostics to help design better trials and improve patient enrollment in Alzheimer's disease studies.