Protocol Design Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic 3/13/2026

    Tr1X Bio Co-founder and CEO David de Vries explains how moving Type 1 regulatory T Cell (Tr1) therapies into new indications reshapes every facet of first-in-human trial design.

  7. PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients 3/13/2026

    Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.

  8. How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment 3/12/2026

    The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.

  9. The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development 3/9/2026

    Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

  10. Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial 3/3/2026

    Discover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.