Application of Adaptive Designs Used in Clinical Trials of Anti-Cancer Drugs
10.3971/j.issn.1000-8578.2025.25.0555
- VernacularTitle:抗肿瘤药物临床试验适应性设计的应用
- Author:
Zhaocong WANG
1
;
Zhu DAI
1
;
Xinjun LIANG
2
Author Information
1. Drug Clinical Trial Institution, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430079, China.
2. Phase I Clinical Research Center, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430079, China.
- Publication Type:REVIEWS
- Keywords:
Anti-cancer drugs;
Clinical trials;
New drug development;
Adaptive design
- From:
Cancer Research on Prevention and Treatment
2025;52(12):1029-1034
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trials of anti-cancer drugs are characterized by long cycles, high risks, large investments, complex efficacy evaluations, and numerous influencing factors. Traditional experimental design is slow in progress and high in cost, which to some extent increases the uncertainty of research. With the guidance of domestic and international policies and the development of clinical trial methodologies, adaptive design has emerged. Flexible adaptive designs can shorten the clinical trial time of anti-cancer drugs, which is conducive to the discovery of truly effective anti-cancer drugs and therapies, thereby increasing the efficiency and success rate of new drug research and development. Starting from the characteristics of clinical trials of anti-cancer drugs, this article reviews the adaptive designs adopted in current clinical trials, summarizes the characteristics and differences of various adaptive design methods by introducing specific research and development cases, and discusses the problems and challenges faced. This work aims to provide methodological references for clinical trials of anti-cancer drugs.
