Objective:To investigate the current status of vocational training for pediatric clinical research coordinators (CRC), and discuss the construction of base-based pediatric CRC training, and to promote the ability of pediatric CRCs.Methods:From July 25 to October 16, 2023, an anonymous self-designed questionnaire survey was conducted through the Wenjuanxing platform to investigate the current situation of pediatric CRC vocational training and base training needs. The data were collated using Excel. Categorical data were described as numbers and percentages.Results:A total of 328 usable questionnaires were returned. Only 7.62% (25 people) believed that existing CRC training was sufficient and could meet actual work needs; 4.88% (16 people) responded that there was no training; 46.34% (152 people) believed that the training was insufficient to support actual work needs; 87.50% (287 people) believed that continuous CRC training was needed; 46.95% (154 people) preferred experienced CRCs for teaching, who should have at least 3 years of CRC work experience; and 46.95% (154 people) preferred a duration of 3 months for CRC training. The preferred training methods were: practice under the direction of experienced CRCs (90.85%, 298 people), step-by-step teaching of practical skills (88.41%, 290 people), case analysis and discussion (87.20%, 286 people), process simulation (83.23%, 273 people), and lecture-based teaching (76.52%, 251 people). The preferred post-training assessment methods were: case analysis (76.52%, 251 people), operation simulation (74.09%, 243 people), process simulation (73.17%, 240 people), written examination (66.16%, 217 people), and interview (63.72%, 209 people).Conclusions:The current pediatric CRC training is not enough to meet actual work needs. It is urgent to develop and promote a CRC training system that can meet work needs, laying the foundation for the construction of pediatric clinical research ecology in China.

【Objective:】 To analyze and explore the key points of the ethical review of real-world research in pediatric population, and to provide reference for ethical review of real-world research in pediatric population. 【Methods:】 According to the characteristics of real-world research and pediatric clinical trials, the review points of real-world research in pediatric population were analyzed and discussed in comparison with the principles and focus of ethical review in general clinical research. 【Results:】 The ethics committee should pay particular attention to the review of informed consent, privacy protection, risk benefit assessment, cost and compensation, and should also take into account the research design, data governance, research conflicts of interest, research registration and publication, etc., and conduct scientific and reasonable ethical review of real-world research in pediatric population. 【Conclusion:】 Clinical trials in pediatric population should have stricter and scientific ethical review, which can not only protect the interests of vulnerable groups of minors, but also standardize real-world research in pediatric population and promote the healthy development of pediatric clinical research, so as to better protect children and promote their health.

By collecting 475 protocol violation reports of pediatric clinical trials accepted by the ethics committee of a grade A tertiary hospital from January 2016 to December 2022, and conducting classification statistics of the responsible body, types of violation, and natures of violation, this paper analyzed and discussed the specific reasons and response measures for protocol violation. The results showed that the most common types of protocol violation included missed medication and incorrect medication dosage for pediatric research participants, missed laboratory inspection, over-windowed follow-up, and non-compliance with inclusion/exclusion criteria. And the responsibility bodies were pediatric research participants and/or their guardians, followed by the researchers. Besides, the sponsor, clinical trial coordinator, and other factors also contributed to protocol violation. Establishing awareness of responsible body, emphasizing subject management, building sound quality control system, and strengthening ethical supervision are the main countermeasures to prevent and reduce protocol violation in pediatric clinical trials, which helps to protect the safety and rights of pediatric research participants and promote standardized research in pediatric clinical trials.

Objective:To understand the current situation and problems of pediatric drug clinical trials in China, and provide reference for the healthy development of pediatric drug clinical trials.Methods:Such keywords as " pediatrics" " children" " annual reports" " children′s drug research and development" " policies" were used, to search for information on China′s pediatric drug research and development policies and regulations, pediatric drug clinical trial institutions and pediatric drug clinical trial professional registration status, as well as pediatric drug clinical trial project registration status as of October 2023 on the drug clinical trial institution registration management information platforms and relevant government department websites. Then descriptive analysis was made on the collected information.Results:China has released 9 policies and regulations on pediatric drug research and development, supporting the development of new varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children, and giving priority review and approval to pediatric drugs. 477 drug technology guiding principles have been released, but only 14 of them were specifically designed for pediatric populations. As of March 20, 2023, there were a total of 272 registered pediatric drug clinical trial institutions, accounting for 20.72% of the total number of registered institutions. The top 5 provinces for their number of registered institutions were Guangdong province (34), Henan province (21), Zhejiang province (20), Beijing (20), and Jiangsu province (18); A total of 26 clinical trial specialties for pediatric drugs have been registered, with the largest number of registrations being pediatric respiratory (143), pediatric hematology (72), pediatrics other (71), pediatric endocrinology (68), and pediatric neurology (64). From 2020 to 2022, the proportion of pediatric drug clinical trial registration projects in newly registered drug clinical trials was 8.8% (129/1 473), 8.3% (168/2 033), and 8.3% (164/1 974), respectively, while clinical trials conducted only in the pediatric population accounted for 2.2% (33/1 473), 3.0% (61/2 033), and 3.2% (64/1 974), respectively.Conclusions:The policies and regulations on pediatric drug research and development in China still need further improvement. The number of registered pediatric drug clinical trial institutions and pediatric specialties is lower than that of adults and distributed unevenly. Clinical trial registration projects for pediatric drugs, especially those conducted in the pediatric population, account for a relatively small proportion. It is recommended to further improve the policy system for drug research and development in the pediatric population, optimize the layout of pediatric drug clinical trial institutions and specialties in the country.

Objective:To evaluate the current status of the registered pediatric drug or vaccine clinical trials in China for the purpose of providing a reference for the development of pediatric clinical trials in China.Methods:We collected the data about registered pediatric clinical trials that were conducted from September 6, 2013(Mandatory registration start date) to September 6, 2019 (Cut-off date) at Chinadrugtrials.org.cn platform. The survey items included trial name and number, drug classification, sponsor′s information, current trial status, completion status, etc. The clinical trials were categorized by drug group (includes chemical medicine, traditional Chinese medicine and natural medicine, biological products) and by vaccine group.Results:During the six years 349 pediatric clinical trials were registered on the platform, including 162 pediatric drug trials and 187 vaccine trials. The numbers of chemical drugs and biological products registered in 2018 were 23 and 11, respectively, the highest in the history. The number of pediatric clinical trials of traditional Chinese medicine and natural medicine was 11 in 2014, but from 2015 to 2018 only 2 to 4 trials were registered each year. The overall completion rates of the registered drug and vaccine clinical trials were 22.8% (37/162) and 41.7%(78/187), respectively. Only 42 international multicenter pediatric clinical trial projects were registered on the platform. The numbers of drug and vaccine phase Ⅰ clinical trials were 4 and 46, respectively. Thirty-six pediatric endocrine system agent clinical trials were carried out, with the largest number of all the drug categories registered on the platform.Conclusions:In recent years the number of registered pediatric drug and vaccine clinical trials increased in China. However, the number is still very limited. It is urgent to further promote the development of pediatric clinical trials.

Objective: To investigate the knowledge regarding clinical research among children at 8-18 years of age. The survey results will form the basis for developing public education program for this population. Methods: The survey was conducted among children at 8-18 years of age using WeChat and spot investigation between January 2016 and January 2017. According to different developmental stages, the survey population was divided into four groups: age 8-10, 11-13, 14-15 and 16-18 years. The level of knowledge regarding clinical research was analyzed. Results: Totally 1 329 questionnaires were issued and 1 233 effective questionnaires were returned with a recovery rate of 92.8%. The overall awareness rate regarding clinical research was 32.8% (405/1 233) . It revealed that 282 (22.9%) individuals thought that clinical research was to treat people like experimental rats. When asked "who have the final decision on research participation", the percentages of those who chose oneself, parents or guardian and doctor were 44.6% (550/1 233), 74.2% (915/1 233) and 36.8% (454/1 233) respectively. When asked "If you want to participate a study, but your parents or guardian do not agree, what would you do?", 33.9% (418/1 233) of individuals will "give up". As to "If you do not want to participate a study, but your parents or guardian think you should, what would you do?", 51.3% (632/1 233) chose "listen to parents" and 28.8% (355/1 233) chose "refuse the suggestions of parents or guardian". As to "what are your greatest concerns of participating an investigation?" , 68.1% (840/1 233) chose "worry about added pain or discomfort". but 58.0% (715/1 233) thought if "doctors and nurses take good care of me" their "concerns will reduce" or "feel better to participate in the research?". 55.6% (686/1 233) and 49.3% (608/1 233) individuals responded that they will "participate in an research?" when they "know that other people also participate the research" and when they "know the details regarding what will happen after the enrollment". Conclusions The knowledge level of clinical research among children aged 8-18 years were not high. It is very necessary to promote the public education of clinical research for this population and also very necessary to address their concern regarding the research.

To investigate the knowledge regarding clinical research among children at 8-18 years of age. The survey results will form the basis for developing public education program for this population. Methods The survey was conducted among children at 8-18 years of age using WeChat and spot investigation between January 2016 and January 2017. According to different developmental stages, the survey population was divided into four groups: age 8-10, 11-13, 14-15 and 16-18 years. The level of knowledge regarding clinical research was analyzed. Results Totally 1 329 questionnaires were issued and 1 233 effective questionnaires were returned with a recovery rate of 92.8%. The overall awareness rate regarding clinical research was 32.8% (405/1 233). It revealed that 282 (22.9%) individuals thought that clinical research was to treat people like experimental rats. When asked"who have the final decision on research participation", the percentages of those who chose oneself, parents or guardian and doctor were 44.6% (550/1 233), 74.2% (915/1 233) and 36.8% (454/1 233) respectively. When asked "If you want to participate a study, but your parents or guardian do not agree, what would you do?", 33.9% (418/1 233) of individuals will "give up". As to "If you do not want to participate a study, but your parents or guardian think you should, what would you do? ", 51.3% (632/1 233) chose"listen to parents" and 28.8% (355/1 233) chose"refuse the suggestions of parents or guardian". As to "what are your greatest concerns of participating an investigation?", 68.1% (840/1 233) chose"worry about added pain or discomfort". But 58.0%(715/1 233) thought if"doctors and nurses take good care of me"their "concerns will reduce" or "feel better to participate in the research? ". 55.6% (686/1 233) and 49.3% (608/1 233) individuals responded that they will"participate in an research? "when they"know that other people also participate the research" and when they"know the details regarding what will happen after the enrollment". Conclusions The knowledge level of clinical research among children aged 8-18 years were not high. It is very necessary to promote the public education of clinical research for this population and also very necessary to address their concern regarding the research.

Objective: To analyze the auxiliary diagnostic value of prostate cancer-associated non-coding RNA transcript1(PCAT-1) in serum of colorectal cancer(CRC) patients. Methods: The serum samples were collected from 73 patients with CRC who underwent surgical treatment and were diagnosed by pathology, 54 patients with colorectal polyps and 62 healthy controls at the Affiliated Hospital of Nantong University from October 2015 to January 2017. The serum level of PCAT-1 in CRC patients, colorectal polyps and healthy controls were measured by quantitative real-time polymerase chain reaction, respectively. The relationship between the level of PCAT-1 and the clinical pathologic feature was analyzed. Receiver operating characteristic curve(ROC) was used to evaluate the diagnosis value of PCAT-1, carcinoembryonic antigen(CEA), carbohydrate antigen 199 (CA199) alone and the combination of one of them in CRC. Results: The relative expression of PCAT-1 was 2.190 0(0.852 5, 6.715 0), 0.586 5(0.331 8, 1.697 0), 0.530 0(0.127 5, 0.957 5) respectively in CRC patients, colorectal polyps and healthy controls. The expression level of serum PCAT-1 in CRC patients was not related to the age (U=593, P=0.753 3), sex (U=536, P=0.390 8), tumor size (U=549, P=0.557 2) and location (U=584, P=0.426 7), but there was related to the degree of tumor differentiation (U=30, P=0.038 4) and tumor staging (U=399, P=0.005 0). ROC curve was used to analyze the expression of serum PCAT-1, CEA and CA199 for the diagnostic efficiency of CRC. The area under the curve(AUC) of ROC were 0.836, 0.756, 0.493 respectively in comparing CRC patients with healthy controls. The sensitivity of three joint tests was 93.2%(68/73), which was higher than that of single index. The area under the curve of ROC were 0.739, 0.673, and 0.515 respectively in comparing CRC patients with colorectal polyps. The sensitivity of three joint tests was 95.9%(70/73), which was higher than that of single index. Conclusions PCAT-1 maybe has auxiliary diagnosis of CRC. The combination of PCAT-1, CEA and CA199 remarkably improved the diagnostic efficacy of CRC.(Chin J Lab Med, 2018, 41: 514-518)

Objective: To investigate the risk factors and survival status of hypopharyngeal carcinoma with synchronous second primary carcinoma of the esophagus. Methods: One hundred and sixty patients with newly diagnosed hypopharyngeal carcinoma from January 2009 to December 2012 were retrospectively reviewed. The clinical data, tumor-related information and follow-up results were collected and analyzed. Results: Forty-three synchronous esophageal carcinomas (27%) were detected in 160 patients with hypopharyngeal carcinoma, and most patients (72%) were at an early stage. On univariate analysis, the median age of less than 55 years old (χ²=4.525, P=0.033), excessive alcohol consumption (χ²=6.942, P=0.008) and invasion site more than 3 anatomical regions (χ²=21.503, P=0.000) had a significant correlation with the occurrence of synchronous esophageal carcinomas. Multivariate analysis showed that excessive alcohol consumption (OR=4.787, P=0.029) and invasion site more than 3 anatomical regions (OR=14.391, P=0.000) were independent risk factors. The median survival time was 26 months in 43 patients with synchronous esophageal carcinomas, which was significantly lower than that (58 months) in patients without secondary primary esophageal carcinomas (χ²=11.981, P=0.001). Conclusions There is a high incidence of synchronous esophageal carcinoma in hypopharyngeal carcinoma patients, affecting the prognosis of hypopharyngeal carcinoma. Surveillance for esophageal carcinomas in patients with hypopharyngeal carcinoma, especially in excessive alcohol drinkers, is warranted.

Objective To explore the role of miR-202 in multiple myeloma (MM) cells,and study the regulation of miR-202 on drug sensitivity of MM cells.Methods miR-202 and BAFF mRNA levels were detected by real-time PCR.U266 cells were transfected with miR-202-mimics,miR-202-inhibitor,siBAFF and their negative controls.After above treatments,protein levels of Bcl-2 family and MAPK signaling pathway were detected by Western blot analysis,and the proliferation and apoptosis ability of MM cells were examined by WST-1,Annexin Ⅴ-FLUOS assay,respectively.Results The results showed that the expression ofmiR-202 in CD138+ MM cells (0.304±0.354) and U266 cells (0.052± 0.009) were lower than in normal controls (3.550± 1.126) (P＜0.001,P=0.009),whereas BAFF mRNA levels (5.700±0.734,9.576±2.887) were higher than in normal controls (1.819±0.853) (P＜0.001,P=0.006).The proliferation ability of U266 cells transfected with miR-202 mimics was significantly inhibited than in control group [(56.04±0.021)％ vs (18.89±0.32)％,P=0.002].The result of Western blot showed that the expression of Bcl-2 decreased by about 24％,and the expression of Bax increased by about 124％ in cells transfected with miR-202 mimics.The apoptosis rate in cells transfected with miR-202 mimics was significantly more than in control group [(49.60±4.89)％ vs (26.20±1.28)％,P=0.029].The apoptosis rate in miR-202 mimics combined with Bort group (51.23±5.41)％ was higher as compared with Bort treatment alone (31.70±4.40) ％ or miR-202 mimics control combined with Bort group (27.94±4.04) ％,(P=0.047,P=0.028),whereas the apoptosis rate in miR-202 mimics combined with Thal or Dex had no significant difference compared with miR-202 mimics control [(11.66±1.91)％ vs (10.63±1.74)％,P=0.700;(16.35± 1.32)％ vs (17.43 ± 1.95)％,P=0.400].The inhibitory rate of cell growth in miR-202 mimics combined with Bort group was higher as compared with Bort treatment alone [(36.93±5.98)％ vs (18.18±4.10)％,P=0.029].The expressions of p-JNK protein decreased in U266 cells transfected with miR-202 mimics and treated with Bort.Conclusion miR-202 mimics combined with Bort could inhibit proliferation and induce apoptosis of U266 cells through negative regulating target gene BAFF,which further inhibited the JNK/ SAPK signaling pathway.