2.Application of bridging study design in preventive vaccine clinical trials.
Ya Wen ZHU ; Xin XIA ; Zhuo Pei LI ; Yan Fei WU ; Feng Cai ZHU ; Jing Xin LI
Chinese Journal of Preventive Medicine 2023;57(12):2201-2211
Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.
Humans
;
Research Design
;
Biomedical Research
;
Immunization
;
Vaccines/therapeutic use*
3.Application of bridging study design in preventive vaccine clinical trials.
Ya Wen ZHU ; Xin XIA ; Zhuo Pei LI ; Yan Fei WU ; Feng Cai ZHU ; Jing Xin LI
Chinese Journal of Preventive Medicine 2023;57(12):2201-2211
Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.
Humans
;
Research Design
;
Biomedical Research
;
Immunization
;
Vaccines/therapeutic use*
4.A Comprehensive View on the Progress of Organoid Research with an Emphasis on its Relevance to Disease Characterization.
Chandra KISHORE ; Vaishali JI ; Saurav MALLIK ; Ayan MUKHERJI ; Namrata TOMAR ; Kumar Pati SOUMEN ; Ai Min LI ; Sinthia Roy BANERJEE ; Soumadip GHOSH ; Raza Ali NAQVI
Biomedical and Environmental Sciences 2023;36(10):959-971
5.Circadian rhythm and health: dialogue between traditional Chinese medicine and modern medicine.
Yu-Juan YI ; Kang SUN ; Hong TANG ; Peng-Lai PI ; Shu-Yi ZHANG ; Jia LI ; Zheng SUN
China Journal of Chinese Materia Medica 2023;48(21):5681-5689
Circadian rhythm refers to the daily rhythmic variations in an organism. The irregular lifestyles of modern humans have led to a high incidence of chronic diseases, highlighting an inseparable relationship between disrupted circadian rhythm and disease development. TCM has long discussed rhythmic variations, with records dating back to the Yellow Emperor's Inner Canon(Huang Di Nei Jing), which laid a rich theoretical foundation for the research on circadian rhythm. Modern medical research has provided a more comprehensive explanation of its molecular mechanisms. This article integrated the current understanding of circadian rhythm in both Chinese and western medicine, emphasizing the crucial relationship between rhythm regulation and disease treatment. By highlighting the interdisciplinary nature of the two fields, it offers new directions for exploring the field of chronomedicine.
Humans
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Medicine, Chinese Traditional
;
Acupuncture Therapy
;
Circadian Rhythm
;
Biomedical Research
;
Polygonatum
7.Analysis of the characteristics of retracted scientific papers in the field of global liver diseases published by Chinese scholars.
Qing Yao ZHONG ; Xin Yi ZHANG ; Hong Hui LUO ; Xin JIANG ; Xin Yi ZENG ; Jiao JIANG ; Hui Fang XIA ; Yan PENG ; Mu Han LYU ; Xiao Wei TANG
Chinese Journal of Hepatology 2023;31(1):96-100
Objective: To analyze the characteristics of scientific papers in the field of global liver diseases published by Chinese scholars that were retracted for diverse reasons from the Retraction Watch database, so as to provide a reference to publishing-related papers. Methods: The Retraction Watch database was retrieved for retracted papers in the field of global liver disease published by Chinese scholars from March 1, 2008 to January 28, 2021. The regional distribution, source journals, reasons for retraction, publication and retraction times, and others were analyzed. Results: A total of 101 retracted papers that were distributed across 21 provinces/cities were retrieved. Zhejiang area (n = 17) had the most retracted papers, followed by Shanghai (n = 14), and Beijing (n = 11). The vast majority were research papers (n = 95). The journal PLoS One had the highest number of retracted papers. In terms of time distribution, 2019 (n = 36) had the most retracted papers. 23 papers, accounting for 8.3% of all retractions, were retracted owing to journal or publisher concerns. Liver cancer (34%), liver transplantation (16%), hepatitis (14%), and others were the main areas of retracted papers. Conclusion: Chinese scholars have a large number of retracted articles in the field of global liver diseases. A journal or publisher chooses to retract a manuscript after investigating and discovering more flawed problems, which, however, require further support, revision, and supervision from the editorial and academic circles.
Humans
;
Biomedical Research
;
China
;
Liver Diseases
;
Scientific Misconduct
8.Investigation and analysis of Chinese public 's cognition for clinical research.
Aijing LUO ; Juan LIU ; Chang LIU ; Yuxia XIANG ; Guoping YANG ; Zhijun HUANG
Journal of Central South University(Medical Sciences) 2023;48(1):130-137
OBJECTIVES:
Clinical research plays a vital role in disease research and population health. The public is the main source of clinical research volunteers. Understanding the public's cognition of clinical research plays a decisive role in the development of clinical research. This study aims to understand the Chinese public's cognition for clinical research and the influencing factors.
METHODS:
The questionnaire based on Chinese-translated Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment (PARTAKE) was used to investigate the public's cognition for clinical research.
RESULTS:
Of the 2 513 valid respondents, 91.84% had heard of "clinical research", 91.76% of the respondents believed that clinical research was beneficial to society, 65.90% were willing to participate in clinical research, 87.50% believed that confidentiality was a very important thing, 73.70% believed that their personal information had been protected when participating in clinical research, and, 46.40% did not know whether volunteers participating in clinical research could receive adequate compensation. Educational levels, employment status, and annual income impacted in public perceptions of willingness to participate in clinical research, especially in privacy protection, informed consent, whether clinical research is intended for society, compensation for clinical research, and safety of clinical research (all P<0.01).
CONCLUSIONS
The Chinese public's cognition level for clinical research is acceptable, but there is still a lot of room for improvement in privacy protection, informed consent, and compensation. By designing a reasonable knowledge training program for clinical research and using the multimedia, improving access to the relevant knowledge, more public will know about clinical research recruitment information, which is of great significance for the development of clinical research in China.
Humans
;
China
;
East Asian People
;
Educational Status
;
Surveys and Questionnaires
;
Public Opinion
;
Knowledge
;
Biomedical Research
9.Magnetic Resonance Imaging Studies of Neurodegenerative Disease: From Methods to Translational Research.
Neuroscience Bulletin 2023;39(1):99-112
Neurodegenerative diseases (NDs) have become a significant threat to an aging human society. Numerous studies have been conducted in the past decades to clarify their pathologic mechanisms and search for reliable biomarkers. Magnetic resonance imaging (MRI) is a powerful tool for investigating structural and functional brain alterations in NDs. With the advantages of being non-invasive and non-radioactive, it has been frequently used in both animal research and large-scale clinical investigations. MRI may serve as a bridge connecting micro- and macro-level analysis and promoting bench-to-bed translational research. Nevertheless, due to the abundance and complexity of MRI techniques, exploiting their potential is not always straightforward. This review aims to briefly introduce research progress in clinical imaging studies and discuss possible strategies for applying MRI in translational ND research.
Animals
;
Humans
;
Neurodegenerative Diseases/pathology*
;
Translational Research, Biomedical
;
Magnetic Resonance Imaging/methods*
;
Brain/pathology*
;
Head/pathology*
10.Visualization analysis of research hotspots in pathogenesis of diabetic nephropathy in China.
Wei ZHANG ; Feng Jiao HU ; Chun Xiu YAO ; Bao Ping LI ; Mei ZHANG ; Xi Ming YANG
Chinese Journal of Preventive Medicine 2023;57(7):1075-1081
The aim of this study is to analyze the research hotspots and development trends in the field of pathogenesis of diabetic nephropathy in China from 2013 to 2022. Based on China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, China Science and Technology Journal Database, China Biology Medicine disc, Web of Science core collection and PubMed database, the related literatures in the field of pathogenesis of diabetic nephropathy in China from 2013 to 2022, were retrieved to establish the database, and the VOSviewer software was used for bibliometric analysis. A total of 1 664 Chinese and 2 149 English literatures are included in this study. The scientific research results from 2013 to 2022 have shown an overall increasing trend. The research hotspots in the field of pathogenesis of diabetic nephropathy in China are mainly concentrated in Podocytes, Oxidative stress, Inflammation, Renal fibrosis, Urine protein, etc. The frontier hotspots in this field include Biomarkers, Nrf2, Gut microbiota, NLRP3 inflammasome, Apoptosis, MicroRNA, etc. Through visual analysis, the research hotspots and frontier trends of the pathogenesis of diabetic nephropathy in China can be visually presented, and then provide new ideas and directions for the further in-depth research on the pathogenesis of diabetic nephropathy.
Humans
;
Apoptosis
;
Asian People
;
China/epidemiology*
;
Diabetes Mellitus
;
Diabetic Nephropathies/etiology*
;
MicroRNAs
;
Biomedical Research/trends*

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