scholarly journals The changing landscape of anti-lymphoma drug clinical trials in mainland China in the past 15 years (2005–2020): A systematic review

2021 ◽  
Vol 8 ◽  
pp. 100097
Author(s):  
Haizhu Chen ◽  
Yu Zhou ◽  
Xiaohong Han ◽  
Yuankai Shi
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Mainland China ◽  
The Past

Changes in clinical trials of cancer drugs in mainland China over the decade 2009–18: a systematic review

2019 ◽  
Vol 20 (11) ◽  
pp. e619-e626 ◽  
Author(s):  
Ning Li ◽  
Hui-Yao Huang ◽  
Da-Wei Wu ◽  
Zhi-Min Yang ◽  
Jun Wang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Mainland China ◽  
Cancer Drugs

scholarly journals Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020)

2021 ◽  
Vol 8 ◽  
Author(s):  
Wen-Wen Wu ◽  
Xing Ji ◽  
Hao Wang ◽  
Feng Chen ◽  
Qian Ding ◽  
...  
Keyword(s):  
Resource Allocation ◽  
Clinical Trials ◽  
Drug Development ◽  
Mainland China ◽  
Developed Countries ◽  
Chinese Government ◽  
Pediatric Drug ◽  
Development Environment ◽  
Pediatric Drug Development ◽  
The Past

In mainland China, there remains a shortage of pediatric drugs. The Chinese government has recently launched policies and incentives to encourage pediatric drug development and clinical trials. However, data on the characteristics or development trends of these trials are limited. In this review, we extracted source data from the Chinese Clinical Trials Registry and Information Transparency Platform and systematically reviewed the pediatric clinical trials conducted in mainland China from 2009 to 2020, a comprehensive process evaluation of the pediatric drug clinical trials development in the past decade, providing data support to policy makers and industry stakeholders. We included 487 pediatric clinical trials. Over the past decade, the number of pediatric trials has increased, especially since 2016. The most common therapeutic areas were infectious diseases (n = 108, 22.2%), agents for preventive purpose (n = 99, 20.3%), and neurological and psychiatric diseases (n = 71, 14.6%). The number of clinical trials involving epilepsy (39, 10.1%), asthma (33, 8.5%), and influenza (24, 6.2%) were the highest. The distribution of leading institutions is unbalanced in mainland China, with most units in East China (34.0%) and few in Southwest China (6.9%). China has made progress in improving the research and development environment of pediatric drugs and increasing pediatric trials. However, a wide gap in pediatric drug development and clinical trials quality exists between China and the developed countries. The pharmaceutical industry in China has faced grim setbacks, including study duplication, lack of innovation, poor research design, and unbalanced resource allocation. Thus, we suggest that the Chinese government should adjust their policies to improve innovation and clinical design capacity, and optimize resource allocation between regions.

scholarly journals Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China

2019 ◽  
Author(s):  
Huiyao Huang ◽  
Dawei Wu ◽  
Qi Fan ◽  
Jun Wang ◽  
Shuhang Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trend Analysis ◽  
Time Trend ◽  
Insurance Coverage ◽  
Mainland China ◽  
Cancer Drug ◽  
Drug Trials ◽  
The Past ◽  
Insurance Rate

Abstract Background: To analyze the time trend and regional difference of insurance coverage of cancer drug trials in mainland China for the past decade, thus to provide data support for the improvement and implementation of related policies, such as clinical trial insurance and ethical review in China. Methods: Based on the national authoritative database, “Drug Clinical Trial Registration and Information Disclosure Platform”, the time trend analysis of insurance coverage of cancer drug trials was conducted, from both the perspectives of trials and participants. Meanwhile, the group comparisons between seven regions, as well as different drug types and study phases, were also performed. Data processing and analysis were carried out using SAS 9.4. Mann-Kendall test was used for trend analysis, and chi-square test was used to conduct group comparisons. Results: A total of 1433 clinical trials were finally included, with 1153 (80.5%) trials being international. In average, the insurance rate of trials was 75.9%, and it was steadily increased by 7.8% annually. While the insurance coverage of Chinese participants was 58.8%, and it showed a wavy upward trend. Compared with international trials (90.0%), insurance rate of domestic trials (72.4%)) was significantly lower ( P < 0.001), but the rate gap decreased gradually. The comparisons by region showed that, the insurance rate for clinical trials in Northeast China (83.3%) was the highest, followed by South area (80.7%), North area (78.1%), and that for Northwest China (37.5%) was lowest. Compared with chemicals (74.8%) and biological products (79.9%), trials on traditional Chinese medicine had significantly lower rate of insurance (30.4%). For different study phase, insurance coverage in BE studies was the lowest (57.1%), followed by phase II trials, while it achieved the highest in phase III trials (85.1%). Conclusions: The insurance coverage of cancer drug trials in mainland China has been increasing steadily over the past decade. However, the regional differences are significant. To promote insurance coverage emphatically in underdeveloped areas could be our work emphasis in the near future. Although this study specially included cancer drug trials, the results could also provide reference for trials in all other fields.

scholarly journals Risk factors for post-ERCP pancreatitis: a systematic review of clinical trials with a large sample size in the past 10 years

2014 ◽  
Vol 19 (1) ◽  
pp. 26 ◽  
Author(s):  
Jian-Jun Chen ◽  
Xi-Mo Wang ◽  
Xing-Qiang Liu ◽  
Wen Li ◽  
Mo Dong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Clinical Trials ◽  
Sample Size ◽  
Large Sample Size ◽  
Large Sample ◽  
The Past

scholarly journals 1612. Listeriosis in Mainland China: A Systematic Review

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S588-S588
Author(s):  
fan zhangling ◽  
Xie Jing ◽  
Wang Huanling
Keyword(s):  
Systematic Review ◽  
Mortality Rate ◽  
Monitoring System ◽  
Clinical Characteristics ◽  
Meat Product ◽  
Mainland China ◽  
The Past ◽  
Sporadic Cases ◽  
Healthcare Associated ◽  
Chinese And English

Abstract Background The aim of present study is to conduct a systematic review to better understand the epidemiological and clinical characteristics of listeriosis cases in mainland China. Methods The six most widely used Chinese and English databases were searched. Records on cases of listeriosis in mainland China reported from 2011 to 2017 were extracted. Clinical data of patients and information on clinical isolates of Listeria were collected and analyzed. Results A total of 136 records and 562 listeriosis cases were reported. The number of cases was much higher than that reported in the past decade. The 227 included non-perinatal listeriosis cases had a mortality rate of 23.78%. Of the 231 perinatal listeriosis cases, 32.68% resulted in abortion and/or newborn death. All listeriosis cases were reported as sporadic cases. Only 3 cases were traced to a meat product, while 33.12% were healthcare-associated cases. Conclusion The number of listeriosis cases in China may have previously been underestimated. Perinatal cases in mainland China took a much higher proportion compared with what is usually described. Considering the high number of listeriosis patients in China, a comprehensive monitoring system for listeria is urgently needed in China. Disclosures All authors: No reported disclosures.

scholarly journals Trends of Phase I Clinical Trials of New Drugs in Mainland China Over the Past 10 Years (2011–2020)

2021 ◽  
Vol 8 ◽  
Author(s):  
Chen Chen ◽  
Ning Lou ◽  
Xin Zheng ◽  
Shasha Wang ◽  
Haizhu Chen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Phase Ii ◽  
Innovation Policy ◽  
Mainland China ◽  
Annual Growth Rate ◽  
Therapeutic Area ◽  
Phase I Clinical Trials ◽  
The Past ◽  
Innovative Drugs

Background: In recent years, the number of clinical trials initiated in China has increased rapidly. The aim of this study was to overview the changing landscape of phase I clinical trials in mainland China from 2011 to 2020.Methods: We analyzed phase I clinical trials registered on 3 websites including the Chinese Clinical Trial Registry, ClinicalTrials.gov, and the China National Medical Products Administration Center for Drug Evaluation platform.Findings: A total of 2,842 phase I clinical trials were posted from January 1, 2011, to December 31, 2020. The overall number of clinical trials for innovative drugs was 1,497, accounting for half of all the phase I clinical trials (53%). Among these 1,486 innovative drug clinical trials, 924 were newly tested drugs with an average annual growth rate of 59%. Biological drug research increased significantly from 22.6% during 2011–2015 to 33.3% during 2016–2020. These principal investigators (PIs) of these clinical trials were mainly from Beijing (n = 871), followed by Shanghai (n = 496) and Jiangsu (n = 281). As for the therapeutic area of phase I clinical trials, cancer took up the most percentage of all the clinical trials (35%), followed by infectious disease (9%), nervous system disease (9%), etc. Most phase I clinical trials are conducted on healthy volunteers (n = 1,642, 57.8%), some cancer drugs are conducted in patients with cancer (n = 846, 29.8%), and only a few clinical trials were conducted in the elderly (n = 7). Among these clinical trials of the newly tested innovative drugs, the first in human (FIH) clinical trials accounted for 82% (744), and the First in Chinese (FIC) clinical trials only took up 18% (167). Only a small number of drugs could be made the transition to phase II (n = 207, 22%). In addition, despite the number of newly tested drugs during 2011–2015 (n = 163) was much less than that in 2016–2020 (n = 761), the percentage of drugs that could enter into phase II clinical trials in 2011–2015 (34%) was higher than that in 2016–2020 (20%).Conclusion: In the past 10 years, the development of phase I clinical trials has achieved great progress in mainland China due to the novel design and drug innovation policy. Nevertheless, future efforts are needed to make for improving the phase transition success rate of innovative drugs.

Abstract #273: Benefits of Extended Release Metformin: Systematic Review of the Ongoing Clinical Trials

2016 ◽  
Vol 22 ◽  
pp. 69
Author(s):  
Hemant Thacker ◽  
Rajeev Chawla ◽  
Navneet Agrawal ◽  
Rohit Kapoor ◽  
Noel Somasundaram ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Extended Release

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

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