计划和进行剂量优化试验时的统计和实践考虑。
关键词: Optimal dose Project Optimus adaptive design benefit–risk trade-off
Mesh : Humans Research Design Maximum Tolerated Dose Dose-Response Relationship, Drug Software Clinical Trials, Phase I as Topic / methods Clinical Trials, Phase II as Topic / methods United States United States Food and Drug Administration Clinical Trials, Phase III as Topic / methods
来 源:
DOI:10.1177/17407745231207085
PDF(Pubmed)