Progress in Clinical Trials of Tumor Immunodrugs in the United States
Li Wan （ The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui, China ）
Ye Zhang （ The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui, China ）
https://doi.org/10.37155/2717-5278-0101-4Abstract
Malignant tumors are a key factor that threatens human health. With the continuous development of molecular biology, immunology and oncology, tumor immunodrugs have gradually become an effective means to suppress malignant tumors after surgery, radiotherapy and chemotherapy. The United States, as a leading country in the development of tumor immunodrugs, has rich clinical trial practice experience and comprehensive clinical trial considerations. Therefore, this article intends to explore the progress of clinical trials of tumor immunodrugs in the United States in terms of the alternative endpoints of clinical trials, clinical trials of adolescent tumor patients, and the design of a single clinical trial main plan for multiple drugs and/or multiple tumor subgroups, thereby providing a reference for optimizing the design of clinical trials in China, expanding the application scope of tumor immunodrugs, and speeding up the process of marketing new drugs.
Keywords
Tumor immunity; clinical trials; alternative endpoint; adolescent patients with cancer; clinical trial designFull Text
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[15]FDA. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics guidance for industry. [2018-09-28]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM621817.pdf.
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[22]Yuce Biology. How to consider oncology guided by biomarker? [2017-05-25]. https://www.sohu.com/a/143466299_730586.
[23]Wang MX, Lou DH. Consideration of General Design for Clinical Trials of Innovative Antitumor Biotechnology Drugs. Chinese Journal of Rational Drug Use 2015,12(10):51-56.
[24]Dingxiangyuan. Survey of Cancer Status in Adolescents and Youth. [2016-04-14]. http://pediatr.dxy.cn/article/488001?trace=drugs.
[25]CAEFI, Clinical evaluation and Research Committee of Chinese Pharmaceutical Association, Center for regulatory science excellence of APEC, Peking University Clinical Research Institute, China Pharmaceutical Enterprises Association, China Pharmaceutical Industry Association, China Chamber of Commerce for Import&Export of Medicines & Health Products. Current difficulties and challenges during the design and conduct stages of clinical trials in China. Chin J New Drugs 2018,27(11):1225-232.
Copyright © 2019 Li Wan, Ye Zhang
Publishing time:2019-12-31
This work is licensed under a Creative Commons Attribution 4.0 International License
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