Protocol Design Featured Articles

  1. 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. 

  2. 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.

  3. RWE Is Ready — Decision Making For Pharmaceuticals Isn't 4/1/2026

    Gorana Capkun of Merck, KGaA, Darmstadt, Germany discusses the growing role of real-world evidence in clinical trials, highlighting a gap between regulatory momentum and pharma adoption— and the challenge of turning data into better decisions.

  4. Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design 3/31/2026

    Opus Genetics CEO George Magrath, MD, shares the team’s experience with an adaptive Phase 1/2 trial design for an ocular gene therapy.

  5. Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment Response 3/30/2026

    Learn how Bayesian digital twins are trained, validated, and trusted in clinical settings and explore the potential for integrating these models into interventional trials.

  6. Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing 3/27/2026

    Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.

  7. From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs 3/25/2026

    Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

  8. Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem 3/23/2026

    When a patient feels no effect or a worsening effect because a known treatment effect was or wasn't experience, that's the "nocebo" effect. Strategic Advisor Jama Pittman discusses how this effect could impact regulatory reviews.

  9. The Art Of Finding And Keeping The Right KOL 3/18/2026

    Learn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.

  10. Wanted: More Women For Clinical Trials 3/13/2026

    A new national survey from UPMC’s Center for Connected Medicine examines why women remain underrepresented in clinical trials. The research highlights key barriers such as fear of side effects, time and travel burdens, and limited awareness about how trials work. In a conversation with UPMC’s Nicole Ansani, we explore what sites and sponsors can do to make trials more accessible and appealing to women.