[Application of seamless phase â
¡/â
¢ design in vaccine clinical trials].
Zhonghua Liu Xing Bing Xue Za Zhi
; 45(4): 602-607, 2024 Apr 10.
Article
em Zh
| MEDLINE
| ID: mdl-38678360
ABSTRACT
The seamless phase â
¡/â
¢ design integrates independent phase â
¡ and phase â
¢ clinical trials into a continuous, phased adaptive clinical trial design. Compared with traditional independent phase â
¡ and phase â
¢ 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 â
¡/â
¢ design concept and offer valuable insights into its implementation. It accomplishes this by presenting a clinical trial example featuring a phase â
¡/â
¢ 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Ensaios Clínicos Fase III como Assunto
/
Ensaios Clínicos Fase II como Assunto
Limite:
Humans
Idioma:
Zh
Revista:
Zhonghua Liu Xing Bing Xue Za Zhi
Ano de publicação:
2024
Tipo de documento:
Article