Protocol Design Featured Articles

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial 2/24/2026

    Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).

37. Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic 2/20/2026

    Pilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.

38. The Problem With Excluding Children From GLP-1 Trials In The U.S. 2/19/2026

    In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.

39. FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now 2/13/2026

    On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.

40. My SCOPE Groundhog Day Experience 2/12/2026

    From feasibility inefficiencies to overdesigned trials and overloaded investigative sites, the conversations at SCOPE were thoughtful and candid. The problem isn’t ignorance. It’s execution. Until simplification shows up in shorter timelines, leaner protocols, and measurable relief for sites, we may continue gathering each year to discuss the same issues — with the same data.