The number of investigator-initiated trials(IIT)projects in medical institutions has increased rapidly,yet there are certain issues such as uneven quality and insufficient consideration of research design.The scientific review and ethical review of IIT complement each other.To improve the research quality and review efficiency of IIT and reduce review repeatability,this paper described the current situation of scientific review and ethical review of IIT in a tertiary A hospital.Combined with literature analysis,the common issues in scientific review and ethical review were summarized into four types:standardization,reliability,safety,and lag.Corresponding to these common issues,the reasons for their occurrence were analyzed as the lack of unified review points,the ambiguity of each review focus,the lack of review communication and exchange,and the lack of ability and awareness of relevant personnel.The explored solutions included establishing a collaborative review mechanism,by unifying the key points of collaborative review,clarifying the review responsibilities of each committee,building a review communication mechanism with the help of information technology,strengthening training and publicity,and other means.These solutions aimed to promote the organic combination of scientific review and ethical review,fully leverage the synergistic effect,improve the efficiency of review,and promote the high-quality and healthy development of IIT.

ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials， promote clinical trial progress， and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials， analyzing the advantages and challenges of decentralized drug clinical trials， and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review， and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility， applicability， and rationality， the adequacy of informed consent， the protection of rights and interests and privacy of subjects， as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties， pay attention to the rights and interests of subjects， and gradually promote the implementation of decentralized drug clinical trials.

Objective:This study aims to improve the management level and quality of horizontal scientific research contracts in hospitals, reduce the risk of contract management, and explore an efficient mode of information management of horizontal scientific research contract management.Methods:Taking a Tertiary Grade A hospital as an example, this study described and summarized the management status of horizontal scientific research contracts from 2018 to 2022, sorted out the potential risks and prevention and control nodes of the review, signing, performance, and archiving of horizontal scientific research contracts in the whole cycle management process, and designed an information management model according to the relevant elements of risk prevention and control and the standardized requirements of contract management, thereby developing information platform related functions.Results:The horizontal research contract management function of the clinical research platform based on the integration concept was available to meet the requirements of risk prevention and control of horizontal research contracts, and the contract review and signing cycle of the information management mode was shortened by 33.33% and 31.95% respectively compared with the traditional management mode. The platform realized a standardized whole process management of contract submission, review, repair and revision, signing, performance, and filing.Conclusions:Information management can effectively reduce the risk of horizontal scientific research contract management. It is necessary to strengthen the docking and interaction function with other information platforms and further explore the information auxiliary function to improve the refined management effect of horizontal scientific research contracts.

Objective:To explore the management strategies of conflicts of interest(COI) by analyzing the definition, manifestations, and implications of COI related to clinical research.Methods:This study summarized the definitions and types, manifestations, and implications of different groups of COI in clinical research. It explored the management response of medical institutions to the COI related to clinical research.Results:Conflicts of Interest could be divided into economic and non-economic conflicts of interest, showing different manifestations in different groups. COI occurs in a variety of links involved in clinical research, and the overall disclosure ratio of COI is low, which might have adverse effects on institutions, investigators, clinical research quality, and subjects.Conclusions:COI management should be implemented by strengthening the construction of the COI management system, strictly following the principle of public disclosure, and strengthening education and training, to improve the quality and credibility of clinical research.

The number of investigator-initiated trials(IIT)projects in medical institutions has increased rapidly,yet there are certain issues such as uneven quality and insufficient consideration of research design.The scientific review and ethical review of IIT complement each other.To improve the research quality and review efficiency of IIT and reduce review repeatability,this paper described the current situation of scientific review and ethical review of IIT in a tertiary A hospital.Combined with literature analysis,the common issues in scientific review and ethical review were summarized into four types:standardization,reliability,safety,and lag.Corresponding to these common issues,the reasons for their occurrence were analyzed as the lack of unified review points,the ambiguity of each review focus,the lack of review communication and exchange,and the lack of ability and awareness of relevant personnel.The explored solutions included establishing a collaborative review mechanism,by unifying the key points of collaborative review,clarifying the review responsibilities of each committee,building a review communication mechanism with the help of information technology,strengthening training and publicity,and other means.These solutions aimed to promote the organic combination of scientific review and ethical review,fully leverage the synergistic effect,improve the efficiency of review,and promote the high-quality and healthy development of IIT.

Objective:This study aims to improve the management level and quality of horizontal scientific research contracts in hospitals, reduce the risk of contract management, and explore an efficient mode of information management of horizontal scientific research contract management.Methods:Taking a Tertiary Grade A hospital as an example, this study described and summarized the management status of horizontal scientific research contracts from 2018 to 2022, sorted out the potential risks and prevention and control nodes of the review, signing, performance, and archiving of horizontal scientific research contracts in the whole cycle management process, and designed an information management model according to the relevant elements of risk prevention and control and the standardized requirements of contract management, thereby developing information platform related functions.Results:The horizontal research contract management function of the clinical research platform based on the integration concept was available to meet the requirements of risk prevention and control of horizontal research contracts, and the contract review and signing cycle of the information management mode was shortened by 33.33% and 31.95% respectively compared with the traditional management mode. The platform realized a standardized whole process management of contract submission, review, repair and revision, signing, performance, and filing.Conclusions:Information management can effectively reduce the risk of horizontal scientific research contract management. It is necessary to strengthen the docking and interaction function with other information platforms and further explore the information auxiliary function to improve the refined management effect of horizontal scientific research contracts.

Objective:To explore the management strategies of conflicts of interest(COI) by analyzing the definition, manifestations, and implications of COI related to clinical research.Methods:This study summarized the definitions and types, manifestations, and implications of different groups of COI in clinical research. It explored the management response of medical institutions to the COI related to clinical research.Results:Conflicts of Interest could be divided into economic and non-economic conflicts of interest, showing different manifestations in different groups. COI occurs in a variety of links involved in clinical research, and the overall disclosure ratio of COI is low, which might have adverse effects on institutions, investigators, clinical research quality, and subjects.Conclusions:COI management should be implemented by strengthening the construction of the COI management system, strictly following the principle of public disclosure, and strengthening education and training, to improve the quality and credibility of clinical research.

Faced with the increasing demand for technological innovation, how to effectively carry out and regulate the export of medical-related scientific research data has become an urgent issue. The author reviewed the current requirements and status of data export in China and abroad, as well as the relevant requirements for medical data management in China, and introduced the practical experience of the first data compliance export case of medical field in China. In view of the main difficulties in the management of medical-related scientific research data export, such as the lack of multi-professional background members of the project team, the difficulty in writing professional documents, the relatively single template, the lack of personalized templates suitable for different professional field, and the need for homogenization of regulatory standards and requirements, it is proposed to rely on a qualified third-party platform in the form of entrusted business, adopt the optional mode under the general declaration template, establish unified regulatory standards, pay attention to the important data and national core data involved in the data export, pay attention to the ethical issues, and replace the original data with derivative data, and keep to " necessity principle" and " minimization principle", so as to provide reference for medical institutions and management departments to strengthen the standardized management and security guarantee of medical-related scientific research data export.

Objective:To explore potential predictors of refractory Mycoplasma pneumoniae pneumonia (RMPP) in early stage. Methods:The prospective multicenter study was conducted in Zhejiang, China from May 1 st, 2019 to January 31 st, 2020. A total of 1 428 patients with fever >48 hours to <120 hours were studied. Their clinical data and oral pharyngeal swab samples were collected; Mycoplasma pneumoniae DNA in pharyngeal swab specimens was detected. Patients with positive Mycoplasma pneumoniae DNA results underwent a series of tests, including chest X-ray, complete blood count, C-reactive protein, lactate dehydrogenase (LDH), and procalcitonin. According to the occurrence of RMPP, the patients were divided into two groups, RMPP group and general Mycoplasma pneumoniae pneumonia (GMPP) group. Measurement data between the 2 groups were compared using Mann-Whitney U test. Logistic regression analyses were used to examine the associations between clinical data and RMPP. Receiver operating characteristic (ROC) curves were used to analyse the power of the markers for predicting RMPP. Results:A total of 1 428 patients finished the study, with 801 boys and 627 girls, aged 4.3 (2.7, 6.3) years. Mycoplasma pneumoniae DNA was positive in 534 cases (37.4%), of whom 446 cases (83.5%) were diagnosed with Mycoplasma pneumoniae pneumonia, including 251 boys and 195 girls, aged 5.2 (3.3, 6.9) years. Macrolides-resistant variation was positive in 410 cases (91.9%). Fifty-five cases were with RMPP, 391 cases with GMPP. The peak body temperature before the first visit and LDH levels in RMPP patients were higher than that in GMPP patients (39.6 (39.1, 40.0) vs. 39.2 (38.9, 39.7) ℃, 333 (279, 392) vs. 311 (259, 359) U/L, both P<0.05). Logistic regression showed the prediction probability π=exp (-29.7+0.667×Peak body temperature (℃)+0.004×LDH (U/L))/(1+exp (-29.7+0.667×Peak body temperature (℃)+0.004 × LDH (U/L))), the cut-off value to predict RMPP was 0.12, with a consensus of probability forecast of 0.89, sensitivity of 0.89, and specificity of 0.67; and the area under ROC curve was 0.682 (95% CI 0.593-0.771, P<0.01). Conclusion:In MPP patients with fever over 48 to <120 hours, a prediction probability π of RMPP can be calculated based on the peak body temperature and LDH level before the first visit, which can facilitate early identification of RMPP.

Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.