A Utility-based Bayesian Optimal Interval (U-BOIN) Phase I/II Design to Identify the Optimal Biological Dose for Targeted and Immune Therapies

. Author manuscript; available in PMC: 2021 Mar 3.

Published in final edited form as: Stat Med. 2019 Oct 17;38(28):5299–5316. doi: 10.1002/sim.8361

A3	Repeat step A2 until the number of patients treated on one of the doses reaches s₁, and then move to stage II. We recommend s₁ = 12 as the default value, while s₁ = 9 to 15 generally yields good operating characteristics.