Ontology highlight
ABSTRACT:
SUBMITTER: Wang Z
PROVIDER: S-EPMC10187767 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
Wang Zheyu Z Wang Fujun F Wang Chenguang C Zhang Jianliang J Wang Hao H Shi Li L Tang Zhuojun Z Rosner Gary L GL
Statistics in biopharmaceutical research 20210209 4
The success of drug development of targeted therapy often hinges on an appropriate selection of the sensitive patient population, mostly based on patients' biomarker levels. At the planning stage of a phase II study, although a potential biomarker may have been identified, a threshold value for defining sensitive patient population is often unavailable for adopting many existing biomarker-guided designs. To address this issue, we propose a two-stage design that allows for simultaneous biomarker ...[more]