Protocol Design Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.