Designing Studies that Work in Complex Settings

About this episode

The episode discusses the importance of integrating operational feasibility into study design for rare disease programs to ensure successful execution and meaningful data generation.

Rare disease programs force teams to confront operational realities much earlier in development, particularly when advanced modalities, limited patient populations, and complex site requirements intersect. In this episode of The Emerging Biotech Leader , hosts Kim Kushner and Ramin Farhood are joined by Brendan Slagle, Senior Director, Medical at SSI Strategy to discuss why operational feasibility needs to be built into study design from the beginning rather than addressed later during execution. Site readiness, patient burden, follow-up care, delivery logistics, and cross-functional alignment all become critical much earlier in development, especially in studies where there is little room for operational inefficiency. Breaking down silos across clinical operations, medical affairs, regulatory, investigators, and patient communities becomes critical in these settings. Waiting too long to involve these perspectives can create studies that are scientifically sound but difficult to execute in practice. Designing studies that patients and caregivers can realistically participate in becomes critical for generating meaningful data and sustaining enrollment over time. Generating…

People in this episode

Hosts: Kim Kushner, Ramin Farhood

Guest: Brendan Slagle

Topics covered

• rare disease
• study design
• operational feasibility
• clinical development
• patient engagement
• cross-functional alignment

Keywords

• rare disease
• study design
• operational feasibility
• patient burden
• clinical operations
• medical affairs
• regulatory
• investigators
• patient communities

Mentioned in this episode

Organizations: SSI Strategy

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