Residential College | false |
Status | 已發表Published |
Characteristics of clinical trials of new oncology drugs approved in China | |
Yang, Jing1; Yang, Ji2; Hu, Yuan Jia1,3,4 | |
2024-03-01 | |
Source Publication | Cancer |
ISSN | 0008-543X |
Volume | 130Issue:5Pages:671-682 |
Abstract | Background: Since reforms were introduced to incentivize drug innovation in 2015, the Chinese pharmaceutical market has experienced unprecedented prosperity, with more new drugs than ever before, especially anticancer treatments. In 2021, Chinese regulatory agencies issued the new guideline for clinical research and development of antitumor drugs, triggering a series of responses on the drug market. Limited research has outlined the nature of the original new drugs in China to understand the dynamic response of the market. Methods: The objective of this article was to map the clinical development of approved new oncology drugs in China from 2015 to 2021 and differed from previous studies by focusing on original new drugs, using the United States as a benchmark, and elaborating the endogenous features of clinical trials. Results: Clinical trials conducted in China have risen to a level similar to that of the United States in many aspects of trial design, but there is still distance between the implementation and operational details of clinical trials. In the meantime, China has made significant breakthroughs in drug approval. Greater than 60% of novel anticancer drugs in China received accelerated approved for their first listing. Approximately 90% of the pivotal clinical trials supporting initial drug approval used surrogate measures as end points, and one half were nonrandomized or did not have a control group. However, duplicate development without evidence of a clinical advantage compared with current therapies was widely observed. Conclusions: By presenting a multidimensional landscape of clinical trials and approvals in the real world, this review allows interested researchers, developers, and even regulators to understand what has been done and what should be done next in anticancer drug development in China. |
Keyword | Clinical Evidence Drug Lag Novel Anticancer Drugs Pivotal Clinical Trials Programmed Death-1 (Pd-1) Inhibitors Programmed Death-ligand 1 (Pd-l1) Inhibitors |
DOI | 10.1002/cncr.35106 |
URL | View the original |
Indexed By | SCIE |
Language | 英語English |
WOS Research Area | Oncology |
WOS Subject | Oncology |
WOS ID | WOS:001104474400001 |
Publisher | WILEY111 RIVER ST, HOBOKEN 07030-5774, NJ |
Scopus ID | 2-s2.0-85177176470 |
Fulltext Access | |
Citation statistics | |
Document Type | Journal article |
Collection | DEPARTMENT OF PHARMACEUTICAL SCIENCES Institute of Chinese Medical Sciences THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU) |
Corresponding Author | Hu, Yuan Jia |
Affiliation | 1.State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao 2.School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, China 3.DPM, Faculty of Health Sciences, University of Macau, Macao 4.Centre for Pharmaceutical Regulatory Sciences, University of Macau, Macao |
First Author Affilication | Institute of Chinese Medical Sciences |
Corresponding Author Affilication | Institute of Chinese Medical Sciences; Faculty of Health Sciences; University of Macau |
Recommended Citation GB/T 7714 | Yang, Jing,Yang, Ji,Hu, Yuan Jia. Characteristics of clinical trials of new oncology drugs approved in China[J]. Cancer, 2024, 130(5), 671-682. |
APA | Yang, Jing., Yang, Ji., & Hu, Yuan Jia (2024). Characteristics of clinical trials of new oncology drugs approved in China. Cancer, 130(5), 671-682. |
MLA | Yang, Jing,et al."Characteristics of clinical trials of new oncology drugs approved in China".Cancer 130.5(2024):671-682. |
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