https://scholars.lib.ntu.edu.tw/handle/123456789/638448
標題: | Novel trial designs for early phase clinical trials | 作者: | CHIA-CHI LIN | 關鍵字: | Accelerated titration design Continual reassessment method | Dose limiting toxicity | Maximum tolerated dose | Optimal biologic dose | Pharmacodynamics | Pharmacokinetics | Seamless design | 公開日期: | 16-九月-2020 | 來源出版物: | Phase I Oncology Drug Development | 摘要: | Oncology phase I trials consist of the dose escalation part and the dose expansion part. The former traditionally uses the "3+3" design, which takes lots of patients, takes a long time, and may expose a substantial proportion of patients to low (and ineffective) doses. Therefore the novel designs such as the accelerated titration design, the continual reassessment method, the escalation with overdose control were implemented in some phase I trials. The latter nowadays serves multiple purposes to confirm the safety profile, to characterize the pharmodynamics/ pharmacokinetics, and to define the objective response rates in certain tumor/molecular types (seamless design). |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/638448 | ISBN: | 9783030476823 | DOI: | 10.1007/978-3-030-47682-3_5 |
顯示於: | 臨床醫學研究所 |
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