Abstract
BackgroundTo depict a comprehensive changing landscape of anti-lymphoma drug clinical trials in mainland China from 2005 to 2020. MethodsA systematic review was conducted on the China National Medical Products Administration Center for Drug Evaluation platform, the Chinese Clinical Trial Registry and ClinicalTrials.gov websites. FindingsA total of 797 anti-lymphoma drug clinical trials registered from Jan 1st, 2005 to Aug 1st, 2020 were identified. The number of trials increased gradually over time, and a notable increase was observed in 2016, with the number growing from 29 in 2015 to 72 in 2016. Trials in phase I (26•1%) and phase II (26•6%) represented the majority, followed by phase III (12•5%) and phase IV (7•4%). Regarding sponsorship, industry-sponsored trials (53•2%) accounted for a slightly larger proportion than investigator-initiated trials (IITs) (46•8%). A dramatic growth for IITs was seen during 2017–2020, with the number increasing from 36 in 2017 to 96 in 2020. Additionally, the proportion of trials involving targeted agents (50•2%) accounted for the largest, followed by trials involving immunotherapy agents (41•0%), and cytotoxic agents (8•0%). Besides, a sustainable growth was observed in the number of leading anti-lymphoma drug clinical trial units in mainland China over the past 15 years. The majority of leading principal units (60•8%) were from Beijing, Shanghai, Guangdong and Jiangsu. InterpretationIn the past 15 years, the research and development of drugs and clinical trials for lymphoma in mainland China has achieved much progression. Future efforts are needed for improving innovation and sustainability of pharmaceutical research and development. FundingChina National Major Project for New Drug Innovation (2017ZX09304015); Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-001).
Highlights
Cancer has become a major public health problem worldwide and is the leading cause of death in China, causing much disease burden [1]
A systematic review of registered clinical trials for lymphoma in mainland China was conducted on the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) website, the Chinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov
Lymphoma is a heterogeneous disease that is usually approached with different treatment modalities, among which medication therapy is the most important therapeutic strategy for most lymphoma subtypes
Summary
Cancer has become a major public health problem worldwide and is the leading cause of death in China, causing much disease burden [1]. Research showed that the mortality of lymphoma and myeloma increased in China from 2004 to 2017, with an estimated 52,000 deaths associated with lymphoma and myeloma occurring in 2017 [3]. Encouraging the research and development (R&D) of anti-lymphoma drugs is important for increasing the availability of new drugs and improving the survival outcomes for lymphoma patients. There were some previous studies focusing on whole landscape of anti-cancer drug clinical trials and the development of specific treatment in China [8,9,10,11,12], to our knowledge, the analysis and review of antilymphoma drug clinical trials is lacking. To depict a comprehensive changing landscape of anti-lymphoma drug clinical trials in mainland China from 2005 to 2020
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