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Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.
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By comparing the training status of clinical research methods between United States and China, this article introduces comprehensive training system in the United States in and after the university, and discusses the problems in clinical research methodology training in China. These issues include that when medical students at school do not receive the training of professional clinical research courses, and after they go to the work, they also lack professional and accurate clinical research methodology training, which make it difficult for doctors to independently conduct clinical research. Therefore, it is recommended that Chinese medical schools should systematically establish clinical research methodology courses for undergraduates and graduate students to cultivate the clinical research capabilities of medical students. Secondly, according to the clinical research levels of doctors, different training models are proposed in the study. The existing social resources should be scientifically guided. We hope our work would provide some references for the improvement of clinical research methodology in China, to promote clinicians to be independently responsible for conducting clinical research, and improve the national medical level.
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Objective:Investigator Initiated Trials (IIT) play a key role in promoting comprehensively the development and homogeneity of clinical diagnosis and treatment, thus, this article aims to explore a set of recommendations for the construction and management of clinical research institutes that support IIT.Methods:Through the combination of literature review and institutional construction practice cases, based on the experience of domestic and foreign universities and well-functioning medical institutions in building clinical research centers, as well as summarizing the construction cases of the clinical research institute of Shanghai Jiao Tong University School of Medicine, to discuss the construction and management plan of such centers.Results:Propose recommendations for the construction and management standards of clinical research centers that support IIT, covering the principles of center construction, basic settings, organizational structure, functional departments, basic platforms, staffing, document management and institutional evaluation.Conclusions:We hope this study can provide reference to universities and medical institutions for the construction of the clinical research institute.
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Objective:To assess possible risk factors and their respective levels in the whole process of investigator initiated trial(IIT)projects proposed in the proposal stage, for reference in formulation of risk management plans.Methods:Through literature analysis and research group discussions, the risk factors of IIT projects and risk level assessment criteria were preliminarily identified, and a consultation questionnaire was developed as a result. Delphi method was used to further optimize the risk factors and determine their risk levels. Data obtained from the consulfation were analysied by descriptive.Results:The recovery rates of two rounds of expert consultation were both 100%, and the degree of expert authority was 0.942. The survey finalized 38 risk factors, including extremely high risk, high risk, medium risk, low risk and very low risk factors of 17(44.7%), 15(39.5%), 3(7.9%), 2(5.3%) and 1(2.6%) respectively.Conclusions:This study determined a risk evaluation system of IIT projects in the proposal stage. This system can identify risks of IIT projects at an early stage, facilitating early intervention of problems existing in such projects, and minimize risks to the rights and safety of patients.
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Objective:To explore the application of information management platform for Investigator Initiated clinical trials (IIT).Methods:Elaborate the design and application of Clinical Information Management Platform (CIMP). Discuss the obstacles in platform development.Results:Compared with regions where clinical research is more developed, there is still a lack of standardized and efficient information management methods in China. Through the construction of the IIT information management platform, the scientific management of the IIT and the SWOT analysis of the use of the platform have been conducted. Further exploration and improvement are needed in terms of the collaboration of the information platform, data standardization, and information sharing security.Conclusions:The management efficiency can be improved by applying CIMP, which will also promote the smooth implementation of IITs.
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Objective With the fast development of Investigator-Initiated Trials (IIT),more and more resources from the national and local governments,universities and hospitals were invested.It is important to clarify the content and methodologies of quality evaluation of the IITs at the early approval stage to assure more complete and systematic quality assessment,improve resource allocation,enhance the research ability,as well as the protection of human subject.Methods This article summarized the content and related safeguarding measures of quality assessment during the early stage of project setup.Discussed relative practice and experiences of our center.Results The contents of quality evaluation include research topic,study protocol,research team and qualifications,quality assurance plan and risk management.The organizing work and attention of the research administrative department,qualified departments and experts,as well as information platform are the required safeguarding measures for effective assessment.Conclusions Quality evaluation of IITs at the early approval stage is critical segment of study quality assurance.More attention should be paid to make every effort counts.
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Objective To improve clinical research capability and quality,this study aims to explore the methodological support system of Investigator Initiated Trials (IITs).Methods By comparing the clinical research supporting system between commercial and academic organization at home and abroad,this study summarized their characteristics and make systematic analysis combined with IITs.Results Compared with international level,there is an urgent need to improve of domestic,professional support for clinical research.Academic clinical research supporting academic system could better satisfy the requirement of IITs in China.Taking Shanghai Jiao Tong University School of Medicine as an example,this paper introduces the a collaborative construction model,namely Multiple-center Academic Clinical Research Organization (MACRO),based on two levels of clinical research institutes in university and affiliated hospitals.At universities level,we focused on development of clinical research,top-level study design,clinical research methodology,clinical research professionals and standardized clinical research platform.At hospitals level,project process management can be emphasized,and which will be the main implementation content to build an applied clinical research technology center in MACRO.Conclusions With the construction of MACRO,the functional module paradigms of academic clinical research centers in university can be effectively linked to affiliated hospitals.This will be conducive for establishing collaborative support system,which is centered on academic research and complementary functions with multiple centers,improving full-time technical team and further enhancing the scientific validity and research quality of IITs.
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Objective :To compare therapeutic effect of propafenone and amiodarone on paroxysmal supraventricular tachycardia (PSVT) and their safety .Methods : A total of 90 PSVT patients ,who were treated in our hospital from Jan 2013 to May 2018 ,were selected .Patients were randomly and equally divided into propafenone group and amio—darone group ,each group received corresponding medication based on routine treatment for 24h.Blood pressure , heart rate ,cardiac function indexes :LVEDV ,LVESV and LVEF before and after treatment ,cardioversion time , successful cardioversion rate within 60 min and incidence of adverse reactions during treatment were observed and compared between two groups .Results : There was no significant difference in successful cardioversion rate (propafenone group 91.11% vs.amiodarone group 93.33%, P＝1.000) between two groups .Compared with be—fore treatment ,on 24h after treatment ,there were significant reductions in blood pressure and heart rate in two groups , P＝0. 001 all ;but there was no significant difference between two groups before and after treatment , P＞0.05 all.Cardioversion time of propafenone group was significantly shorter than that of amiodarone group [ (12. 66 ± 2.06) min vs .(22. 80 ± 2.28 ) min ] , P＝ 0. 001 .Compared with propafenone group on 24h after treatment , there was significant rise in LVEF [ (63. 24 ± 3.67)% vs.(66. 83 ± 4.01)%] ,significant reductions in LVEDV [ (96.65 ± 5.24) ml vs.(92. 09 ± 4.37) ml] and LVESV [ (38.40 ± 2.87) ml vs.(30. 13 ± 7.34) ml] in amioda—rone group , P＝ 0. 001 all.Total incidence rate of adverse reactions in amiodarone group was significantly lower than that of propafenone group (8.89% vs.24. 44%) , P＝0. 048. Conclusion : Propafenone and amiodarone possess significant therapeutic effect on PSVT .Propafenone possesses shorter cardioversion time ,while amiodarone posses— ses less adverse reactions and improve cardiac function .Therefore ,medication should be selected properly according to patient′s specific condition in clinic .
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Objective To provide a suggestion for physicians participating clinical research of how to write a clinical trial protocol correctly and standardly in the course of clinical trial design.Methods By exploring clinical trial protocols,we analyzed their common problems in the methodological details and the reporting standards with respect to typical cases.Results The common problems in the clinical trial protocols are:lack of clear outline when selecting the research subject;incorrect selection of research type;lack of comprehensiveness and accuracy of PICO elements;inappropriate application of methodologies in randomization and blinding;absence of statistical analysis plan;incorrect calculation of sample size;non-standard format of the protocol etc.Conclusions Many clinicans do not have enough understanding of the key points in designing the clinical trial and writing the protocol.However,the quality of the clinical trial protocol determines success or failure of the whole study.Therefore,carefully handling the technical details of PICO elements,methodology and statistics application,and writing the protocol in accordance with the CONSORT (Consolidated Standards of Reporring Trials) 2010 and SPIRIT (Standard Protocol Items:Recommendations for Interventional Trials)2013 Statements,are the key points that each clinical researcher should pay attention to.
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Objective Through investigating the clinicians’ scientific research level and weakness,we can carry out targeted clinical research training systematically,and then strengthen their utilization of clinical resources and data,and finally promote the transformation of scientific research resuits.Methods Filling and submitting the online questionnaires through WeChat,a popular chatting tool in China,physicians from 13 affiliated hospitals of a university in Shanghai have joined this research.Results 507 valid questionnaires have been received online:In terms of clinical research capacity,there seemed to be more barriers in the following issues:comprehension of the types and applications to design a clinical trial,formulation of the details including PICO elements(Patient-Intervention-Comparison-Outcome),methodological application including the category and principle of randomization,the category and principle of blind method and how to control the confounding elements and probable bias,and statistical problems in scientific research including discrimination of the different definition between FAS(Full Analysis Set) based on the principle of ITT(Intention-To-Treat) and PPS(Per-Protocol Set),how to write a standardized SAP(Statistical Analysis Plan) and how to calculate the sample size of a trial),and various management of clinical trials including data management,follow-up management,adverse event management and so on,and writing a protocol and a CRF (Case Report Form) in a standard and professional way.As for the needs for training,the top three topics were how to design a clinical research in a standardized style,how to practice the methodology and how to utilize the statistical skills into clinical trials.Conclusions Standardized design and writing of clinical trial protocols according to the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items:Recommendations for Interventional Trials),and the application of epidemiological and statistical methods are still short boards that most clinicians need to improve urgently,also are what they most concerned about at the same time.So it is necessary for physicians to receive systematic clinical research training to enhance their scientific research capacity.
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Objective:This study aimed to investigate the associations between single-nucleotide polymorphism (SNP) of IGF-1 and IGFBP-3 gene and risk of non-smoking female lung cancer in Chinese population. Methods:Genotyping was performed using the TaqMan method in 287 histologically confirmed non-smoking female lung cancer cases and 281 healthy controls. Results:The geno-type distributions of IGF-1 polymorphisms were significantly different between cases and controls (P3 cm. Conclusion:The IGF-1 polymorphism was associated with the risk of lung cancer and prognosis among non-smoking female. More rigorous laboratory studies of large sample population and functional studies are warrant-ed to confirm our findings.
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Objective To conduct a descriptive epidemiological study on thyroid cancer incidence in the urbanarea of Tianjin during 2002 - 2006 and to analyze the secular trend of incidences based on previous data of 26 years and those from Shanghai and the United States. Methods Annual percent change (APC%) of thyroid cancer incidence and the rank of all-site cancer profiles were estimated. The secular trend of different histological incidences and the proportion changes were analyzed. Results The incidence of female thyroid cancer was 6. 55/100000 in 2006, ranking the eighth in the female cancer profile. The incidence of thyroid cancer showed an increased secular trend in recent 26 years, especially a 5.7-fold increase in the papillary thyroid cancer (PTC). The incidence for female increased by 267% in 2006 compared to that in 1981, APC% was 3. 1%. The variation ranked second among all the female tumors. The incidences of thyroid cancer in Shanghai and the United States also elevated with time.Conclusions Thyroid cancer has been one of female common tumors from a once less common tumor,especially the proportion of PTC is expanding. It suggests that further study on the risk factors and preventive efforts should be made.
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Objective: To analyze the association of thrombocytosis with the prognosis of patients with gastric cancer.Methods: The clinical materials of 782 patients with gastric cancer who underwent initial surgery in our hospital between January 1995 and December 1999 were retrospectively analyzed.Kaplan- Meier and Log-Rank test were used to analyze the data.Prognostic factors were analyzed by multivariate Cox proportional hazards model.Results: Thrombocytosis oc-curred in 11.4% (87/782) patients.The platelet level was not significantly different among patients of different gender, tumor stage, and histological differentiation (P>0.05).However, a significant difference was observed in the platelet level among patients with different age and surgical approach (P<0.05).The 1-, 3-, and 5-year survival rates were 75.0%, 40.1% and 28.9% in patients without thrombocytosis and 52.8%, 16.9%, and 13.5% in patients with thrombocytosis (P=0.002).Univari-ate analysis showed that histological differentiation, pathological stage, surgical approach and thrombocytosis significantly affected the survival of patients.While age and gender had no significant impact on patient survival.Multivariate analysis showed that pathological stage, surgical approach, and thrombocytosis were independent prognostic factors for gastric can-cer.The relative risk of death of patients with thrombocytosis was elevated by 1.454 times (RR=1.454, 95% CI: 1.135～1.861, P=0.005).Conclusion: Thrombocytosis is an independent prognostic indicator for the survival of initially treated pa-tients with gastric cancer.