Objective The BOIN12 design was improved based on conditional weighted likelihood method to solve the optimal dose exploration in the case of delayed toxicity and efficacy of drugs.Methods The conditional weighted likelihood method was used to estimate the toxicity rate and conditional efficacy rate.The improved BOIN12 design was compared with other phase Ⅰ-Ⅱ design through simulation to evaluate its performance.Results Simulation results show that the improved design still has excellent statistical performance in different scenarios and the trial duration is greatly shortened.Conclusion The improved design can addresses both toxicity and efficacy delays in phase Ⅰ-Ⅱ trials.
维普
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