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<p>This review examines the evolving landscape of clinical trial design in hidradenitis suppurativa (HS), focusing on the challenges posed by high placebo responses and increasingly stringent endpoints. The goal is to identify barriers and propose strategies to improve validity and inclusivity to real-world HS populations. We highlight demographic gaps, underrepresentation of minority and pediatric populations, and the exclusion of patients with comorbidities. High placebo responses, driven by disease variability and subjective endpoints, continue to confound results. Adaptive trial designs, Bayesian-augmented analyses, and more inclusive eligibility criteria are emerging as promising solutions. Longer-term studies reveal that meaningful clinical improvements may require extended treatment durations. Addressing placebo effects, demographic disparities, and endpoint selection is critical for HS research. Strategic trial design, standardized flare management, and innovative statistical methods can enhance reliability and generalizability. These approaches will be essential for future trials to improve outcomes for diverse HS patient populations.</p>

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Strategic Trial Designs To Avoid Pitfalls, Interpreting and Reducing High Placebo Rates, Era of More Stringent Trial Endpoints (e.g.: HiSCR 50 → HiSCR75/90/100, NRS 0/1)

  • 期刊论文

  • 发表日期：

    2025年11月21日

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  • Maneli Doroudian Tehrani,
  • Hoang Truong,
  • Martina L. Porter

摘要

This review examines the evolving landscape of clinical trial design in hidradenitis suppurativa (HS), focusing on the challenges posed by high placebo responses and increasingly stringent endpoints. The goal is to identify barriers and propose strategies to improve validity and inclusivity to real-world HS populations. We highlight demographic gaps, underrepresentation of minority and pediatric populations, and the exclusion of patients with comorbidities. High placebo responses, driven by disease variability and subjective endpoints, continue to confound results. Adaptive trial designs, Bayesian-augmented analyses, and more inclusive eligibility criteria are emerging as promising solutions. Longer-term studies reveal that meaningful clinical improvements may require extended treatment durations. Addressing placebo effects, demographic disparities, and endpoint selection is critical for HS research. Strategic trial design, standardized flare management, and innovative statistical methods can enhance reliability and generalizability. These approaches will be essential for future trials to improve outcomes for diverse HS patient populations.