The Changing Landscape of Anti-Lymphoma Drug Clinical Trials in Mainland China in the Past 15 Years (2005-2020): A Systematic Review

Abstract

Background: To depict a comprehensive changing landscape of anti-lymphoma drug clinical trials in mainland China from 2005 to 2020. Method: A 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. Findings: A total of 797 anti-lymphoma drug clinical trials registered from 2005 to 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 (5 3.2%) 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%). The majority of leading principle unit (60.8%) were from Beijing, Shanghai, Guangdong and Jiangsu, reflecting a severe uneven geographical distribution. Besides, a sustainable growth was observed in the number of leading clinical trial units for lymphoma in China over the last decade. Interpretation: In the past 15 years, the research and development of drugs and clinical trials for lymphoma has achieved much progression. Future efforts are needed for improving innovation and sustainability of pharmaceutical research and development. Funding Statement: China National Major Project for New Drug Innovation (2017ZX09304015) ; Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-001). Declaration of Interests: All authors declare no competing interests.