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Targeted Indication Selection Using Simon 2-Stage Design

Oncology

Learn how Veristat’s biostatistics and strategic consulting teams were able to work with a biotechnology sponsor to prioritize oncology indications through efficient trial design. The results of our collaborative efforts? Early identification of promising indications and reduced trial complexity using a multi-cohort Simon 2-stage approach.

A biotechnology company exploring the potential of a novel oncology therapy engaged us to design and manage a Phase 2 study evaluating multiple tumor-specific cohorts. The sponsor aimed to identify which indications showed the most promising early signs of efficacy rather than launching multiple independent studies requiring more patients and higher investment.

In this case study, learn how our team was able to work with the sponsor to solve challenges across numerous areas including:

  • Multi-cohort protocol design

  • Cohort prioritization strategy

  • Real-time data monitoring

  • Statistical decision thresholds

  • Interim analysis coordination

  • Regulatory strategy communications

Download our complete case study "Targeted Indication Selection Using Simon 2-Stage Design"

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