Protocol Design Featured Articles

  1. These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials 2/11/2026

    Minovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.

  2. Informed Consent Isn't Broken — But It's Barely Working 2/9/2026

    Former FDA Commissioner Dr. Robert Califf has been blunt about what’s wrong with informed consent in clinical trials. In this article, we offer a high-level look at his three-part Substack series, exploring how consent became more about legal protection than patient understanding — and what needs to change.

  3. Becoming A Backbone Therapy: Lessons Learned With Actuate Therapeutics 2/5/2026

    CEO Dan Schmitt discusses the pursuit of a backbone therapy and how Actuate's current and planned trials are structured to confirm that potential.

  4. Why Dr. Robert Califf Isn't Pulling His Punches Anymore 1/30/2026

    In this exclusive video interview, former FDA commissioner Robert Califf, MD reflects on quality, risk aversion, misinformation, and why clinical trials need sharper focus — not more data. 

  5. Choosing Clinical Research … On Purpose 1/28/2026

    Most clinical research careers begin by accident. Rutgers University is trying to change that with formal training programs designed for today’s academic and industry trial environments. Barbara Tafuto, Ph.D., interim program director of the Master’s in Clinical Research Management program at Rutgers University, explains the program’s genesis and potential impact on the industry. 

  6. Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites 1/27/2026

    Incomplete protocols, lengthy sponsor decision timelines, and uncompensated work plague clinical research sites. Learn why these issues exist and how to address them alongside experts from SCRS and Tufts CSDD.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.