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Objective:Based on the analysis of case report and case series studies involving COVID-19 pregnant women in China, we aimed to discuss the updated management requirements for publication of scientific papers at hospitals in the new circumstances and context.Methods:The case report and case series studies published by domestic scholars in the early stage of COVID-19 outbreak were retrieved. Bibliometrics were used to analyze the research time, research content and research objects of the included literatures.Results:Nearly 200 cases (55%) of the 360 cases of COVID-19 pregnant women could not be clearly excluded from the possibility of repeated reporting. However, all these cases were not disclosed in the paper for possible repeated report.Conclusions:Potential repeated report problem may cause trouble for later meta-analysis, which also may have negative impact for the development of clinical guidelines. The departments of scientific research management at hospital should pay more attention to the management of patient′s data in scientific papers, so that it can better serve the accurate assessment of disease characteristics and epidemic situation, as well as the scientific formulation of clinical guidelines and control strategies.
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Objective:To collect and analyze the non-compliance/protocol violation or deviation reported to the hospital Ethics Committee from 2017 to 2019, to explore the pattern of such events, as well as the causes and related logic. Empirical data evidence, lessons learned and preliminary advice were proposed to improve the understandings, management and implementation of clinical trials regarding to the non-compliance/protocol violation or deviations.Methods:The chi-square test and non-parameter test were conducted using SPSS 22.0.A total number of 754 reports received were analyzed, compared and summarized to provide the preliminary advice.Results:From 2017 to 2019, 754 reports on non-compliance/protocol violation or deviation, which covered 219 projects from 29 clinical departments, were received. 88% of these projects were drug/medical device clinical trials, while other 12% were investigator initiated trials. The reportrd events could be divided into 7 categories. The distribution of project resources, trial types and clinical specialties are significantly different. Meanwhile, the reports submitted by investigators have a lot of space for improvement.Conclusions:There were significant differences in the type and number of reported events on non-compliance/protocol violation or deviation between different trial types, as well as clinical trial specialties. The application report of protocol violation is generally poor. Combined with the working practice, the common reasons for the protocol violation are " the low overall compliance of the subjects" and " the insufficient compliance of the researchers" . Preliminary suggestions for management reform, such as increasing the training for researchers, improving the reporting mode, and regularly issuing follow-up and review research reports are recommended.
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Objective Ethical review is an important safeguard for the development of human subject research.The post approval review during the research process is particularly vital because it is the core method in the ethical review to protect participants' safety and right.In this article,current problems about post approval review were analyzed deeply to explore how to improve the mechanism of post approval review from the combination of management and technical aspect,particularly for the plan of not-for-cause visit.Methods According to the work experiences,literature review,identifying problems,to explore the collaboration to strengthen post approval review with experts,pharmacological institutions and scientific research management department.Results There are more and more frequent ethical issues during the implementation process,besides continuing strengthen the passive continuing review,continuing review guidelines and more detailed active continuing review screening and implementation mechanism should be developed.Conclusions It will prevent the occurrence of injury through establishing more optimal post approval review mechanism and a forehand active prevention strategy,which play an important role in the ethical review of human subject research.
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Objective Discussing the approach to design and implementation of ethical review information management system in clinical research involving human subject.Methods Systematic design and implementation based on ICH GCP,Chinese GCP,Ethical review of biomedical research involving human subjects,Standard Operating Procedure compliant with Asia Pacific SIDCER certification standards,as well as the working experiences of author group.Results According to the specific working procedures in Beijing e-plugger Support Technology Co.Lyd,We implement ethical management system with real-time online interactive work model among investigators,ethical committee secretariat and ethical reviewers,which is prepared for further system optimization and upgrade.Conclusions The application of ethical review information management system make the ethical management work more reliable,efficient,and also improve the quality of ethical review,which helps a lot in safeguarding the development of medical science.
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Objective To provide valid data and useful genetic counseling in the clinical application of non‐invasive prenatal test (NIPT) ,fetal chromosomal disorder were screened by massive parallel sequencing and made a follow‐up study .Methods Preg‐nant women with Down screening in high‐risk were screened by NIPT ;NIPT verified high‐risk individuals were suggested for kary‐otyping ;and we follow up on whoever showed low risk by NIPT before and after their deliveries .Results (1)Totally 1 676 cases of pregnant women were tested by NIPT ,25 cases prompted to be abnormal ,with an abnormal rate of 1 .49% ,karyotype analysis re‐sults in 12 cases of abnormalit ,the accuracies of NIPT for T21 ,T18 ,XO ,XXY ,and XYY were 99 .93% ,100 .00% ,99 .66% , 100 .00% ,100 .00% respectively ;the accuracy of NIPT for women with advanced paternal age and twins were both 100 .00% ;kary‐otyping positive individuals underwent abortion ,which gives a prenatal intervention rate of 100 .00% .(2)Out of 1 651 cases of NIPT low risk testers ,1 468 cases were successfully followed up ,with a 88 .91% success rate .We found chromosome abnormality with one case of inversion of chromosome 9 (maternal) .(3)Ultrasound‐detection possessed 98 .17% accuracy and 7 .69% in detec‐tion rate;in high‐risk pregnant woman ,Down screening had an accuracy of 0 .88% and false positive rate of 99 .12% ;98 .71%women were avoided prenatal diagnosis via NIPT .Conclusion Compare to ultrasound and maternal plasma screening ,NIPT is a far more accurate prenatal screening approach .To build effective follow‐up and service systems of NIPT is necessary to reduce birth de‐fects in medical institutions .
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<p><b>OBJECTIVE</b>To explore the molecular mechanism for a boy suspected with 3-methylcrotonyl-CoA carboxylase deficiency by neonatal screening.</p><p><b>METHODS</b>PCR and Sanger sequencing were used to identify potential mutations of MCCC1 and MCCC2 genes. SIFT and Polyphen-2 software was used to predict the effect of variant on the protein function and conservation of the variant across various species. Human Splicing Finder and Swiss-PdbViewer4.1.0 were applied to analyze the possible mechanism of the variant.</p><p><b>RESULTS</b>For the proband, a compound heterozygous mutation was discovered in the MCCC1 gene, namely c.539G>T (p.G180V) and c.704_711del (p.A235Vfs*4), which were inherited from his father and mother, respectively. The two mutations have disrupted the protein conformation, which in turn may impact the function of MCC protein.</p><p><b>CONCLUSION</b>The compound heterozygous mutations of the MCCC1 gene may contribute to the 3-methylcrotonyl-CoA carboxylase deficiency manifested by the patient.</p>