A cross-industry scientific community advancing innovative clinical trial design for the benefit of patients worldwide.
Advancing Innovative Clinical Trial Design Worldwide
DahShu Innovative Design Scientific Working Group
Who We Are
The DahShu Innovative Design Scientific Working Group (IDSWG) is a cross-industry scientific community with approximately 200 members drawn from pharmaceutical companies, biotechnology firms, academic medical centers, contract research organizations, health authorities, and patient advocacy organizations across the United States, Europe, and Japan.
Members share a common premise: well-designed clinical trials are among the most powerful tools available for bringing safe and effective treatments to patients. Statisticians, clinicians, pharmacometricians, regulators, patient advocates, and operations professionals work across sub-teams to advance that premise through published methodology, regulatory engagement, and practical guidance.
Member Spotlight
What We Work On
Innovative trial design encompasses methodologies that move beyond the traditional fixed-design randomized trial to make drug development more efficient, flexible, and informative. The IDSWG focuses on six core areas:
Master Protocols
Platform, basket, and umbrella trials that evaluate multiple treatments or patient populations within a single framework.
Adaptive Designs
Trials with pre-specified modifications based on accumulating data, improving efficiency without compromising trial integrity.
Randomization
Modern allocation methods that improve balance and efficiency beyond standard permuted-block approaches.
Rare Diseases
External controls, Bayesian borrowing, decentralized trials, and cell and gene therapy designs for small patient populations.
AI/Integrated Scientific Learning
Machine learning applications to drug repurposing, biomarker identification, and trial simulation.
Patient Advocacy
Integrating patient perspectives into trial design, ensuring studies reflect what matters to the people they are meant to help.
Get Involved
Membership is free and open. Whether you prefer to observe, contribute, or lead, there is a place for you in the IDSWG.
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