Considerations on pivotal clinical trial design of innovative new drugs for hematological malignancies

VernacularTitle:血液肿瘤创新药物关键性注册研究设计要素的审评考虑
Author: Limin ZOU ¹ ; Xinxu LI ; Yueli QI ; Yu DU ; Xiaoming CHEN ; Zhimin YANG
Author Information

1. 国家药品监督管理局药品审评中心，北京　100022
Keywords: Hematological malignancies; New drug review; Pivotal clinical trial
From: Journal of Leukemia & Lymphoma 2022;31(4):246-249
CountryChina
Language:Chinese
Abstract: The rapid changes in the research and development environment of new anti-tumor drugs in China have brought various challenges to drug innovation. How to explore the clinical advantages of new drugs in the early phase, and design scientific, reasonable and efficient pivotal clinical trials for drug registration accordingly, is one of the key challenges. This article takes innovative new drugs for hematological malignancies as an example, comprehensively elaborates the considerations on the timing for entering the pivotal clinical trial and the key elements of the trial design from the perspective of clinical reviewers.