Early Phase Clinical Trial Designs - State of Play and Adapting for the Future

被引：18
作者：
Harrington, J. A. [2 ]
Hernandez-Guerrero, T. C. [2 ]
Basu, B. [1 ,2 ]
机构：
[1] Univ Cambridge, Dept Oncol, Cambridge, England
[2] Cambridge Univ Hosp NHS Fdn Trust, Addenbrookes Hosp, Cambridge, England
来源：
CLINICAL ONCOLOGY | 2017年 / 29卷 / 12期
关键词：
Adaptive design; biomarker; dose escalation methods; early phase clinical trials; phase I trials; CONTINUAL REASSESSMENT METHOD; MOLECULARLY TARGETED AGENTS; DOSE-FINDING DESIGN; I TRIALS; DRUG-COMBINATIONS; CANCER-RESEARCH; TOXICITY DATA; EFFICACY; ESCALATION; HETEROGENEITY;
D O I：
10.1016/j.clon.2017.10.005
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
The process of anti-cancer drug development is complex, with high attrition rates. Factors that may optimise this process include well-constructed and relevant pre-clinical testing and use of biomarkers for patient selection. However, the design of early phase clinical trials will probably play a vital role in both the robust clinical investigation of new targeted therapies and in streamlining drug development. In this overview, we assess current concepts in phase I clinical trials, highlighting issues and opportunities to improve their meaningfulness. The particular challenge of how to design combination trials is addressed, with focus on the potential of new adaptive and model-based designs. Crown Copyright (c) 2017 Published by Elsevier Ltd on behalf of The Royal College of Radiologists. All rights reserved.
引用
收藏
页码：770 / 777
页数：8
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