Analysis of Clinical Trials on Therapies for Prostate Cancer in Mainland China and Globally from 2010 to 2020.
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SUBMITTER: Chen K
PROVIDER: S-EPMC8167212 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundIn recent years, new drug development on lung cancer is in full swing in China. The aim of this study was to overview the changing landscape of anti-lung cancer drug clinical trials in mainland China from 2005 to 2020.MethodsWe analysed anti-lung cancer drug clinical trials registered on three websites including the China National Medical Products Administration Centre for Drug Evaluation platform, the Chinese Clinical Trial Registry and ClinicalTrials.gov.FindingsA total of 1595 anti-lung cancer drug clinical trials from Jan 1st, 2005 to Dec 31st, 2020 were extracted, which included 630 (39•5%) investigator-initiated trials (IITs), 698 (43•8%) domestic industry-sponsored trials (ISTs), and 267 (16•7%) international ISTs. During the past 16 years, the number of anti-lung cancer clinical trials including IITs and domestic ISTs had a remarkable growth, however, the number of international ISTs increased slowly. The number of principal clinical trial units also increased significantly over time. Of the 1595 trials, the largest growth was observed in phase I trials during 2013-2020, with an average annual growth rate of 38•6%. 278 trials were led by principal investigators (PI) from Guangdong, followed by Beijing (n=273) and Shanghai (n=257). Among the 965 ISTs, clinical trials involving targeted drugs (588, 60•9%) accounted for the largest proportion, followed by immunotherapeutic drugs (284, 29•4%), cytotoxic drugs (75, 7•8%), and traditional Chinese medicine (18, 1•9%). In terms of targeted drugs, EGFR-TKIs remained the most studied drugs (225/588, 38•27%). As for immunotherapy, 125 out of 284 (44•01%) trials involved PD-1 inhibitors, 60 (21•13%) trials involved PD-L1 inhibitors, and seven (2•46%) trials involved CTLA-4 inhibitors.InterpretationIn the past 16 years, the development of anti-lung cancer drug clinical trials has achieved much progress in mainland China. The most progress lied in targeted therapy and immunotherapy.FundingThis work was financially supported in part by China National Major Project for New Drug Innovation (2017ZX09304015) and Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-001).
| S-EPMC8315452 | biostudies-literature
Project description:With the improvements in relevant policies, laws, and regulations regarding drug clinical trials in China, the quantity and quality of drug clinical trials have gradually improved, and the development prospects of drug clinical trials for endocrine disorders and metabolism and nutrition disorders are promising. Based on information from the clinical trials from the online drug clinical trial registration platform of the National Medical Products Administration, we aimed to review and evaluate the development of clinical trials of drugs for endocrine disorders and metabolism and nutrition disorders in mainland China from 2010 to 2019, as well as the trends over time. A total of 861 trials were carried out on 254 types of drugs for endocrine disorders and metabolism and nutrition disorders, among which 531 (61.67%) involved endocrine disorders, and 330 (38.33%) addressed metabolism and nutrition disorders. The annual number of clinical trials has been increasing gradually, with a significant increase in 2017. Among them, the proportion of clinical trials with Chinese epidemiological characteristics was relatively large (Wu, Annual Report on Development Health Management and Health Industry in China, 2018). The largest number of trials were for diabetes drugs (55.63%), followed by trials of drugs for hyperlipidemia (19.4%) and those for hyperuricemia (7.9%). It was found that the geographical area of the leading units also showed obvious unevenness according to the analysis of the test unit data. Based on the statistics and evaluation of the data, comprehensive information is provided to support the cooperation of global pharmaceutical R&D companies and research units in China and the development of international multicenter clinical trials in China. This work additionally provides clinical trial units with a self-evaluation of scientific research competitiveness and hospital development strategies. At the same time, it provides a reference with basic data for sponsors and stakeholders in these trials to determine their development strategy goals.
| S-EPMC7931124 | biostudies-literature
Project description: Not available
| S-EPMC10686146 | biostudies-literature
Project description: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).
| S-EPMC8315394 | biostudies-literature
Project description:According to UN forecasts, global population will increase to over 8 billion by 2025, with much of this anticipated population growth expected in urban areas. In China, the scale of urbanization has, and continues to be, unprecedented in terms of magnitude and rate of change. Since the late 1970s, the percentage of Chinese living in urban areas increased from ~18% to over 50%. To quantify these patterns spatially we use time-invariant or temporally-explicit data, including census data for 1990, 2000, and 2010 in an ensemble prediction model. Resulting multi-temporal, gridded population datasets are unique in terms of granularity and extent, providing fine-scale (~100 m) patterns of population distribution for mainland China. For consistency purposes, the Tibet Autonomous Region, Taiwan, and the islands in the South China Sea were excluded. The statistical model and considerations for temporally comparable maps are described, along with the resulting datasets. Final, mainland China population maps for 1990, 2000, and 2010 are freely available as products from the WorldPop Project website and the WorldPop Dataverse Repository.
| S-EPMC4755125 | biostudies-literature
Project description:BackgroundTo assess the temporal changes in the characteristics of ischemic stroke drug clinical trials conducted in mainland China in 2005-2021.MethodsA statistical analysis of registered clinical trials on ischemic stroke was performed using the platform of the Center for Drug Evaluation of China National Medical Products Administration, the Chinese Clinical Trial Registry, and ClinicalTrials.gov websites.ResultsFrom January 1, 2005 to August 1, 2021, a total of 384 registered drug clinical trials on ischemic stroke were identified in mainland China. Over time, the number of trials gradually increased each year, with a significant growth in 2014, from 16 in 2013 to 42 in 2014. Phase IV trials (31.8%) accounted for the majority, followed by phase II (16.4%), phase I (10.9%), and phase III (8.6%). In terms of sponsorship, the proportion of investigator-initiated trials (IITs) (60.7%) was higher than industry-sponsored trials (ISTs) (39.3%). Additionally, trials involving traditional Chinese medicines (TCMs) (36.2%) accounted for the largest proportion, followed by trials involving antithrombotic therapy (19.5%) and cerebral protection agents (16.7%). Furthermore, over the past 17 years, the number of leading drug clinical trial units for ischemic stroke in mainland China has continuously increased. The leading principal units from Beijing, Shanghai, Guangdong, Jiangsu, and Liaoning accounted for the majority of the trials (67.4%).ConclusionIn the past 17 years, great progress has been made in the research and development (R&D) of drugs and clinical trials for ischemic stroke in mainland China. The most extensive progress was observed in TCMs, antithrombotic therapy, and cerebral protection agents. More clinical trials are needed to confirm whether the newly developed drugs can improve the clinical efficacy of ischemic stroke. Simultaneously, more pharmaceutical R&D efforts of innovative drugs are warranted.
| S-EPMC9253749 | biostudies-literature
Project description:ObjectivesChina has experienced a sharply increasing rate of human brucellosis in recent years. Effective spatial monitoring of human brucellosis incidence is very important for successful implementation of control and prevention programmes. The purpose of this paper is to apply exploratory spatial data analysis (ESDA) methods and the empirical Bayes (EB) smoothing technique to monitor county-level incidence rates for human brucellosis in mainland China from 2004 to 2010 by examining spatial patterns.MethodsESDA methods were used to characterise spatial patterns of EB smoothed incidence rates for human brucellosis based on county-level data obtained from the China Information System for Disease Control and Prevention (CISDCP) in mainland China from 2004 to 2010.ResultsEB smoothed incidence rates for human brucellosis were spatially dependent during 2004-2010. The local Moran test identified significantly high-risk clusters of human brucellosis (all p values <0.01), which persisted during the 7-year study period. High-risk counties were centred in the Inner Mongolia Autonomous Region and other Northern provinces (ie, Hebei, Shanxi, Jilin and Heilongjiang provinces) around the border with the Inner Mongolia Autonomous Region where animal husbandry was highly developed. The number of high-risk counties increased from 25 in 2004 to 54 in 2010.ConclusionsESDA methods and the EB smoothing technique can assist public health officials in identifying high-risk areas. Allocating more resources to high-risk areas is an effective way to reduce human brucellosis incidence.
| S-EPMC3987733 | biostudies-literature
Project description:BackgroundThe contribution of hepatitis B virus (HBV) and hepatitis C virus (HCV) to primary liver cancer (PLC) and their association with cancer aggressiveness remains uncertain in China, a country with half of global PLC. We aimed to characterize this using data from four representative medical centers.MethodsIn total, 15,801 PLC patients were enrolled from the centers distributed in Easter5n, Southern, Northern, and Western China from 2003 to 2020. Of those, 7585 with curative surgery were involved in survival analysis. A nomogram was constructed using preoperative parameters to predict postoperative survival.ResultsHepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, and combined hepatocellular cholangiocarcinoma accounted for 93.0%, 4.3%, and 1.6% in PLC, respectively. The seropositivities of HBV and HCV were 84.4% and 3.2% in HCC, respectively. The seropositivity of anti-HCV antibody was significantly higher in HBV-negative than in HBV-positive HCC patients (13.2% vs. 1.1%). Compared to HCV-positive HCC (HCV-HCC), HBV-positive HCC (HBV-HCC) was associated with 12-year earlier onset, higher proportions of males, high α-fetoprotein, large tumor size, advanced Barcelona Clinic Liver Cancer (BCLC) stage, and vascular tumor thrombus. The proportions of HCC and HBV seropositivity increased, whereas that of anti-HCV decreased, from 2003 to 2020. Postoperative five-year survival rate was 73.5%, 64.1%, 34.9%, and 19.7% in HCC at BCLC stage 0, A, B, and C, respectively. The multivariate Cox regression analysis showed that HBV seropositivity, incomplete tumor capsule, vascular tumor thrombus, tumor diameter (≥3 cm), advanced BCLC stage (B+C), α-fetoprotein (≥20ng/ml), and direct bilirubin (>8µmol/L) contributed independently to shorter overall survival (OS); whereas post-operative radiofrequency ablation and second resection independently improved OS in HCC. HCV-HCC had a more favorable prognosis than did HBV-HCC (Log-rank test, P<0.001). A nomogram composed of age, gender, and the preoperative independent risk factors was accurate in predicting postoperative survival in HCC (C-index: 0.735; 95% confidence interval: 0.727-0.743).ConclusionHBV contributes to 84.4% of HCC in China, and actively promotes hepatocarcinogenesis and HCC progression. A favorable postoperative survival obtained in patients at the early BCLC stage highlights the importance of screening for early HCC in high-risk populations. Our preoperative prognosis prediction model is important in clinical decision-making.
| S-EPMC9253580 | biostudies-literature
Project description:Lots of international multi-center clinical trials have been conducted in China over the past 10 years. We also have more and more clinical trials designed and launched by qualified Chinese investigators in recent years, especially after the establishment of the Chinese Thoracic Oncology Group (CTONG) in 2007. These trials are mainly about targeted drugs. The finished ones provided more evidence for the use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in the first-line/maintenance/second-line settings in Chinese patients. The ongoing ones will diversify the use of EGFR-TKIs in 1(st)/2(nd)/3(rd) line settings and help to answer the questions whether patients will benefit from (neo)adjuvant EGFR-TKIs and chemotherapy intercalating and maintenance use of EGFR-TKIs. Here, we introduce far-reaching clinical trials conducted, ongoing and will be launched soon in China.
| S-EPMC4367775 | biostudies-literature
Project description:IntroductionLung cancer is the leading cause of cancer-related morbidity and mortality in the People's Republic of China. Targeted therapies for patients with lung cancer, which depend on accurate identification of actionable genomic alteration, have improved survival compared with previously available treatments. However, data on the types of molecular testing often used in the People's Republic of China, and how they have changed over time, are scarce. We explored the overall landscape of molecular testing of lung cancer in mainland People's Republic of China in the past decade.MethodsWe distributed a stratified random sampling survey of molecular testing to 49 hospitals from members of the Molecular Pathology Collaboration Group of Chinese Anti-Cancer Association which was weighted by the numbers of lung cancer cases in seven different geographic regions in mainland People's Republic of China from 2010 to 2019. The questionnaire contained four parts for all respondents. The questionnaire ascertained the use of approved in vitro diagnostic (IVD) devices published by the Center for Medical Device Evaluation, National Medical Products Administration of the People's Republic of China.ResultsA total of 226,227 NSCLC specimens were tested from 2010 to 2019 in the selected hospitals. The annual number of initiated molecular tests increased over time (p < 0.0001), with an average annual growth rate of 31.8%. A notable increase in the number of molecular tests occurred during 2014 and 2016, which coincided with the approval of the National Medical Products Administration to IVD devices. For the diagnosis of molecular subtypes, EGFR mutation testing was first conducted in year 2007, followed by ALK translocation testing in 2010 and ROS1 in 2011. For other rare genetic variations in NSCLC, BRAF mutation testing was first launched in 2012, MET exon 14 skipping mutation in 2014, HER2 exon 20 mutations in 2017, and RET translocation in 2015. A markedly uneven distribution was also observed in the geography of leading units with the largest number of leading units located in east People's Republic of China (34.7%, 17 of 49) and the smallest number located in northwest People's Republic of China (6.1%, 3 of 49). The growth trends we observed illustrate the progress and increasing capability of molecular testing of lung cancer achieved in mainland People's Republic of China in the decade from 2010.ConclusionsIn the decade 2010 to 2019, progress and increased capability of molecular testing of lung cancer were achieved in mainland People's Republic of China. Further efforts should address the clinical application of next-generation sequencing technology, rare genomic aberrations, and the balance between novel genomic testing techniques and the approval of IVD products.
| S-EPMC8474368 | biostudies-literature