Application of seamless phase Ⅱ/Ⅲ design in vaccine clinical trials
10.3760/cma.j.cn112338-20230731-00050
- VernacularTitle:Ⅱ/Ⅲ期无缝设计在疫苗临床试验中的应用
- Author:
Qian LIU
1
;
Lairun JIN
;
Pengfei JIN
;
Fengcai ZHU
;
Jingxin LI
Author Information
1. 东南大学公共卫生学院，南京 210009
- Keywords:
Vaccines;
Clinical trials;
Seamless phase Ⅱ/Ⅲ design
- From:
Chinese Journal of Epidemiology
2024;45(4):602-607
- CountryChina
- Language:Chinese
-
Abstract:
The seamless phase Ⅱ/Ⅲ design integrates independent phase Ⅱ and phase Ⅲ clinical trials into a continuous, phased adaptive clinical trial design. Compared with traditional independent phase Ⅱ and phase Ⅲ clinical trials, the seamless design offers significant advantages in accelerating drug or vaccine development and improving clinical trial efficiency. Currently, the application of this design in anti-tumor drug research is becoming increasingly mature, and it is gradually expanding to clinical trials of vaccines, including the 9-valent human papillomavirus vaccine, sabin strain inactivated polio vaccine, and others. This paper aims to clarify the seamless phase Ⅱ/Ⅲ design concept and offer valuable insights into its implementation. It accomplishes this by presenting a clinical trial example featuring a phase Ⅱ/Ⅲ seamless design for a 9-valent human papillomavirus vaccine. The article delves into the specific considerations and potential challenges related to implementing the seamless design, aiming to provide valuable insights for optimizing vaccine clinical trials within our country.
