BERD Bites: Case Study – 2-in-1 design in oncology and considerations

The adaptive 2-in-1 design allows us to expand an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. It has generated a lot of interest since its publication in 2018. Comparing to other seamless Phase 2/3 design, 2-in-1 design provides two opportunities to go to Phase 3. In addition, the use of an intermediate endpoint for adaptive decision is a unique feature of the design. A case study in oncology will be presented to provide some insights on selection of interim analysis timing, interim analysis endpoints and GNG decision bar.

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Photograph of Fang Liu. Senior Director Merck and Co. Inc
Fang Liu, PhD
Senior Director, Merck & Co. Inc.