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AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.
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Objective: Systematically summarize the research progress of clinical trials of gastric cancer oncology drugs and the overview of marketed drugs in China from 2012 to 2021, providing data and decision-making evidence for relevant departments. Methods: Based on the registration database of the drug clinical trial registration and information disclosure platform of Food and Drug Administration of China and the data query system of domestic and imported drugs, the information on gastric cancer drug clinical trials, investigational drugs and marketed drugs from January 1, 2012 to December 31, 2021 was analyzed, and the differences between Chinese and foreign enterprises in terms of trial scope, trial phase, treatment lines and drug type, effect and mechanism studies were compared. Results: A total of 114 drug clinical trials related to gastric tumor were registered in China from 2012 to 2021, accounting for 3.7% (114/3 041) of all anticancer drug clinical trials in the same period, the registration number showed a significant growth rate after 2016 and reached its peak with 32 trials in 2020. Among them, 85 (74.6%, 85/114) trials were initiated by Chinese pharmaceutical enterprise. Compared with foreign pharmaceutical enterprise, Chinese pharmaceutical enterprise had higher rates of phase I trials (35.3% vs 6.9%, P=0.001), but the rate of international multicenter trials (11.9% vs 67.9%, P<0.001) was relatively low. There were 76 different drugs involved in relevant clinical trials, of which 65 (85.5%) were targeted drugs. For targeted drugs, HER2 is the most common one (14 types), followed by PD-1 and multi-target VEGER. In the past ten years, 3 of 4 marketed drugs for gastric cancer treatment were domestic and included in the national medical insurance directory. Conclusions: From 2012 to 2021, China has made some progress in drug research and development for gastric carcinoma. However, compared with the serious disease burden, it is still insufficient. Targeted strengthening of research and development of investment in many aspects of gastric cancer drugs, such as new target discovery, matured target excavating, combination drug development and early line therapy promotion, is the key work in the future, especially for domestic companies.
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Humanos , China , Fármacos Gastrointestinales/uso terapéutico , Neoplasias Gastrointestinales , Preparaciones Farmacéuticas , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Objective@#To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019.@*Methods@#The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted.@*Results@#There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%, P<0.001), and the proportion of phase I clinical trials and bioequivalence trials is higher (51.9% vs. 23.4%, 19.4% vs. 1.3%, P<0.001). An accumulative of 27 cancer types were involved for all the cancer drug trials, and lung cancer, solid tumor, and breast cancer were the most common cancer types, with 103, 95 and 49 trials, respectively. For the three cancer types unique to Chinese population, gastric, liver and esophageal cancer, the total number of initiated trials was 47. For all those trials, there were 335 cancer drug varieties, with 86.0% developed by domestic pharmaceutical enterprises, including 300 therapeutic drugs, 30 adjunctive drugs and 5 preventive drugs. In terms of mechanism, targeted drugs and immune drugs were the most popular, accounting for 74.6% and 20.3%, respectively. In addition, 17 anticancer drugs targeting on 11 cancer types were approved in China in 2019.@*Conclusions@#Clinical trials on cancer drugs in China have ushered a booming era, with large number of innovative agents represented by targeted drugs and immune drugs under clinical development or putting into clinical practice. Those local enterprises are playing more and more critical roles. Strengthening clinical research and development on Chinese unique cancer types is the key direction of future work.
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Objective To understand the forming cause of the Oncomelania hupensis snail-existent non-endemic areas of schistosomiasis(SENEAS),and to verify the conclusion of previous studies,so as to provide the evidence for schistosomiasis monitoring in such areas in Nantong City,Jiangsu Province. Methods The controlled field tests were carried out to observe the O. hupensis snails artificially infected by schistosome miracidia in SENEAS. The influence of the soil from SENEAS and the en-demic areas on O. hupensis snails artificially infected by miracidia were observed. Results All the experimental snails could be infected by schistosome miracidia except the smooth-shell snails from Tangyuan Village in the controlled field test environment of SENEAS or the endemic areas. The infection rates of the smooth-shell snails were lower than those of the ribbed-shell snails , but there were no statistically significant differences. The mortality rates of the smooth-shell snails were higher than those of the ribbed-shell snails,which were statistically significant (χ2Xindian = 135.118,χ2Shuangdian = 122.836,χ2Baipu =154.436,χ2Dingyan =138.288,χ2Control=151.923,all P<0.01). There were no significant differences in the infection rates of snails between each test group of the soil from SENEAS and the endemic areas(χ2Rugao=0.071,χ2Rudong=0.216,both P>0.05). Also there was no signifi-cant difference between each test group and the control group without soil(χ2=7.148,P>0.05). Conclusion It is likely to form the spread of schistosomiasis in SENEAS in Nantong City with sufficient amount of infection source of schistosomiasis im-ported. It is still necessary to implement the surveillance of schistosomiasis and O. hupensis snails in Nantong City.
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Objective To study the influence on the tumor after percutaneous intra-tumor injection of ~(32)P-GMS in liver cancer as well as its suitable dose.Methods 24 New Zealand rabbits were used to establish the animal model of VX-2 liver cancer,and divided into A,B,C and D groups with individually 37,74,111 and 148 MBq of ~(32)P-GMS being injected,respectively;and then pathological changes of tumor were observed by light and electron microscope respectively.Result The dose of ~(32)P-GMS was obviously correlated with the radioactivity damage of tumor cells.In the A and B groups,the tumor cells were not observed to disappear completely after injection of ~(32)P-GMS,but in C group,tumor cells were almost completely disappeared and surrounded by a lot of connective tissue.Although the tumor cells were found to disappear completely in D group,normal liver tissues were also involved.Conclusion Percutaneous intra-tumor injection of ~(32)P-GMS with suitable dose that may induce the tumor tissue to be maximally damaged and may also provide some significances to prevent the tumor metastasis.
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Objective To investigate insulin resistance and the effect of physical training on it in the pa- tients with chronic heart failure (CHF). Methods One hundred and twenty NYHAⅡ-ⅢCHF patients were ran- domly divided into a training group( n = 65 ) and a routine therapy group (n = 55 ). Another 35 healthy subjects were recruited as control group. All the patients were treated with routine anti-CHF drugs, and the training group patients had received physical training twice a day in addition. The HOMA-IR, insulin sensitivity index (ISI) , left ventricu- lar ejection fraction (LEVF), left ventricular fractional shortening( LVFS), 6-minute walking distance, heart rate and mean blood pressure were compared between the training and routine therapy groups before and after physical ex- ercise in both groups, and a comparison was made between the patients and the controls before the intervention with regard to HOMA-IR and ISI. Results Comparing with control group, ISI was reduced while the HOMA-IR in- creased (P
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The clinical therapeutic effects of Zhenerkang for 99 cases of children with hypoferric anemia and physique dysplasia were studied in present paper. For the anemia children two mouths of treatment made the Hb content raise by an average of 21.60g/L and the blood concentrations of metallic elements such as Fe,Ca,Zn,Cu,Se,Ge,etc elevate obviously. The drug was more effective for children with hypoferric anemia as compared with the control (Pearl powder).