Objective:To introduce the cultivation model of the scientific research talent echelon in the university-affiliated specialized hospital, and talent cultivation system of Research-Life-Cycle based on this model, summarize its role in promoting discipline development, and propose future measures, providing references for the talent team building and discipline development of specialized hospitals and departments of general hospitals.Methods:This study examined and assessed the effectiveness of the cultivation and the contribution of talents to the advancement of academic disciplines by quantitatively analyzing and comparing the scientific research output and discipline development of personnel trained through the talent echelon policy before and after its implementation for over a decade, and integrating theories related to talent development.Results:Since the implementation of the cultivation model, 116 research talents had completed the cultivation process, accounting for 18% of the hospital′s overall research personnel, and the academic papers echelon talents published as main authors also accounted 60%, which indicated the majority of echelon talents have become the key talents to discipline development and national strategies. The growth rate of the hospital′s papers had significantly increased before and after the policy implementation, with the data rising from 0.16% to the current 1.01% globally.Conclusions:The scientific research talent echelon system has effectively strengthened the cultivation of medical science and technology innovation talents, promoted the formation of the group effect in the hospital, and provided strong support for the development of disciplines. According to the limitations we analyze to the scientific research talent echelon cultivation model, suggestions, for achieving better results in the cultivation of talent echelons, are proposed that we should continuously follow up on national policies to optimize systems, firmly serve for the central task of discipline development, promote the implementation of the comprehensive evaluation to scientific talents, systematically provide young talents with ″real combat″ opportunities, and continuously pursuit the transition from extensive management to refined and personalized management.

Objective:The arrival of the big data era has accelerated the development of information technology in the healthcare sector. Internationally, developed countries such as the United States, the United Kingdom, and the European Union have taken pioneering initiatives in data openness. Since 2015, China has rapidly promoted the application of big data through policy layout. This study aims to help the open and shared development of healthcare big data in our country by investigating the status quo of open and shared healthcare big data at home and abroad.Methods:Through literature research and information integration, this study summarized the development history and current situation of open and sharing health and medical big data at home and overseas, analyzed related problems and challenges, and proposed countermeasures and development suggestions.Results:The open sharing of health and medical big data in developed countries and regions abroad had made outstanding achievements in legislation, standard formulation, platform construction, etc. The domestic policy layout was relatively perfect, and the relevant construction was being actively promoted. Problems and challenges still existed in five aspects, including privacy security, data format standards, data quality, laws and regulations, and property rights and interests.Conclusions:Combined with the problems found in the current research process, the following countermeasures and development suggestions are proposed for domestic health and medical big data open sharing: establish a privacy protection mechanism to ensure data security, unify data standards to improve data interoperability, build a data quality control system to ensure data accuracy, improve laws and regulations to standardize data sharing behavior, clarify the ownership of interests and protect intellectual property rights.

Objective:This study aims to establish a real world study (RWS) quality evaluation model based on Analytic Hierarchy Process -Fuzzy Comprehensive Evaluation Methods (AHP-FCE), and provide a reference basis for researchers and quality control personnel in medical and health institutions.Methods:The evaluation index framework of RWS quality was obtained by analyzing national RWS regulations. Two rounds of Delphi expert consultation were conducted, while the results were statistically analyzed and weighted using the AHP method by Yaahp software. The comprehensive evaluation model of RWS was established by combining AHP and FCE methods.Results:The RWS quality evaluation model based on AHP-FCE methods was constructed, including 6 primary indicators, 31 secondary indicators, and specific indicator evaluation methods, and validated through RWS case analysis.Conclusions:The RWS quality evaluation model constructed in this study is reasonable and practical, which can provide a reference for institutional researchers and quality managers.

Objective:This study aims to acquire the current status of abnormal patent applications in tertiary hospitals, the causes, and the management measures taken.Methods:An electronic questionnaire was used to investigate the administrative department of patents in tertiary hospitals. The main contents of the investigation included the status of abnormal patent applications, the management measures to patent, the causes of abnormal patent applications, and the coping measures.Results:A total of 102 questionnaires were collected. Among the surveyed tertiary hospitals, 64.7% had received notices of abnormal patent applications issued by the National Intellectual Property Administration. The most common reason was " achieving simple functions with complex structures, or combining or stacking with regular or simple features". The most common causes of abnormal patent applications were factors of the patent agency and insufficient patent knowledge of the inventors.Conclusions:The high proportion of tertiary hospitals where abnormal patent applications occurred involved multi-factors. Hospitals need to take multiple measures to improve the quality of patents, such as optimizing management systems, establishing the whole process of patent management mechanisms, strengthening the management of agencies, and conducting intellectual property training.

Objective:This study aims to explore the establishment of strategies for the transformation of scientific and technological innovation achievements in specialized hospitals, and to promote the high-quality development of public hospitals.Methods:By establishing a full chain intellectual property and achievement transformation management system, this study formulated a hierarchical management of scientific and technological achievements through an " open" internal and external linkage model, reserving high-value patents, promoting cross disciplinary cooperation, increasing the service level of professional institutions, strengthening the training of high-level transformation service talents, deepening project full process management, expanding transformation service functions, establishing long-term communication mechanisms, accelerating industrial empowerment to enhance the operational transformation service level and work effectiveness of hospitals, and relying on the Shanghai municipal hospital enterprise collaborative research and innovation platform to promote the strengthening of medical enterprise collaborative innovation.Results:By integrating multiple resources, this study filled in the deficiencies of specialized hospitals, exploring new models for professional and efficient intra hospital achievement transformation, establishing a full chain innovation achievement transfer and transformation system.Conclusions:The innovative transformation strategy helps to enhance the research and innovation capabilities of full-time medical personnel and the quality of innovation achievements, promoting the high-quality development of public specialized hospitals.

Objective:To systematically review the application of Artificial Intelligence (AI) in drug clinical trial management under the Good Clinical Practice (GCP) framework, identify current gaps and shortcomings, and to propose an optimization strategy.Methods:Main academic databases were searched for literature published in Chinese and English between September 2019 and September 2024. Relevant studies were included. Key findings were extracted and summarized.Results:AI applications had been extensively explored and reported in areas such as informed consenting and protection of human subject rights, trial design and implementation, subject screening and recruitment, data processing and management, and reporting. Current literature was predominantly international. Despite a foundation of applied research, issues existed such as lack of standardization, fragmented tools, and insufficient interconnectivity and interoperability.Conclusions:China has marked potential to adopt and integrate AI technologies in drug clinical trial management under the GCP framework. Future efforts should focus on establishing standards, covering end-to-end processes, promoting multi-tool collaboration and data interconnectivity, and building robust data security and ethical protection mechanisms in an AI environment. Seizing the opportunities can enhance drug clinical trial management.

Objective:The study investigated the full-time Clinical Research Coordinators (CRCs) working in hospitals on their current working situation and explored affecting factors to provide suggestions for a professional and systemic clinical research workforce establishment in municipal medical institutions.Methods:A questionnaire survey was designed for CRCs in municipal hospitals in Shanghai, descriptive and one-way cross-tabulation analysis were conducted, using t-test for continuous numerical variables, rank-sum test for count variables and chi-square test for categorical variables.Results:Totaling 177 CRCs in 9 municipal hospitals in Shanghai answered the questionnaire. The average age of the respondents was 28.56±7.299 years old. Their professional background was mainly nursing and pharmacy (139/177, 87.53%), and bachelor degree (114/177, 64.41%). Averagely worked 2.50±1.632 years, the average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. The CRCs employed by hospitals mainly undertook Investigator-Initiated clinical Trial/Research projects (IITs) (26/36, 72.22%), while the CRCs employed by SMO companies mainly undertook Industry-Sponsored Clinical Trial (IST) projects (96/141, 68.09%). 85.88% (152/117) of CRCs held GCP certificates valid within three years, and the proportion of CRCs employed by hospitals held GCP certificates was lower than that of SMO companies ( P<0.05). Among the CRCs employed by hospitals, 23 (63.89%) said they had no position or were not clear about their position; The CRCs in SMO companies were mainly primary and intermediate (χ 2=84.119, P<0.05). The average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. Conclusions:With the development of clinical research, the full-time specialized CRCs in medical institutions mainly have 2 sources: from SMO/CRO companies or self-employment by medical institutions. In general, there are still problems in the CRC talent team as unclear entry standards, insufficient, lack career positioning planning, large mobility, imperfect training system, and imperfect promotion mechanism. It is suggested to unify occupational access standards and set specialty in colleges or universities. Strengthen post-service education and training system, establish multi-party collaborative training mechanism, standardize the assessment and evaluation, improve the job title promotion system, to promote the rapid development of CRC team.

Objective:This study aims to explore the current status and existing issues in the standardized training of medical researchers in China and to propose countermeasures, providing strong support for the enhancement of medical research in China.Methods:Systematic review was employed to analyze the current status of standardized training for medical researchers in China by searching literature from databases including Pubmed, EBSCO, Web of Science, OVID, ACM digital library, ProQuest Dissertations and Theses Global, CNKI, Wanfang, VIP, and China social science library.Results:There were only two publications on the standardized training of medical researchers in China, lacking systematic research and an overall framework. This situation leaded to limitations in the development of medical researchers′ professional skills, research capabilities, and practical experience, hindering the overall improvement of China′s medical research level.Conclusions:This study proposes several countermeasures, including establishing and improving institutional frameworks, strengthening organizational management, optimizing training programs, and enhancing the training support system to elevate the overall level of medical research in China.

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:This study starts from the main problems existing in the current stage of the development of pediatric clinical research in China and focuses on the construction of a clinical research management system. By innovating the platform management model and enhancing personnel skills, we can provide support and assurance for improving the clinical research platform and its sustainable development in the future.Methods:This study established an integrated management platform for Industry-Sponsored Initiated Clinical Research Trial (IST) and Investigator Initiated Clinical Research (IIT) and implement integrated management of IST and IIT projects. At the same time, in response to the weak links in quality management, synchronous training of management and research talents should be implemented to achieve dual improvement in project management quality and platform service efficiency throughout the process.Results:We had optimized the clinical research organization structure, improved the management system, and strengthened the quality supervision of IIT projects by establishing rules and systems to improve the quality and efficiency of project management.Conclusions:Based on analyzing the current situation in China and referring to international experience, we have built a clinical research management platform in line with the development of the hospital, and implemented centralized management of the entire process of IST and IIT projects, strengthened project process quality control, which is expected to provide a reference for peers.