Objective:In the context of the S&T system reforming and research paradigm transforming, the overall thought and the key tasks were proposed.Methods:Combining the theorical & policy analysis, the overall thought and the key points in sectoral S&T management were proposed by the method of comparative and inductive analysis.Results/Conclusions:The overall thought is to expend the narrow sense of "research management" to the broad sense of "S&T management", to promote the macro technology policy to be implemented, and advance the technology breakthroughs by facing the people’s life and health and coordinating the technology resources and forces, so as to enhance the supporting role of S&T innovation for health. The key task points are as follows, i. e., organizing R&D tasks by focusing on the health demand (1 st), standardizing the management by improving policy system (2 nd), coordinating the resources by integrating the diverse platforms (3 rd), constructing the talents staff by the research practicing (4 th), optimizing the innovation ecology by strengthening supervision (5 th).

Objective:To analysis the laws and regulations related to human genetic resources, this study analyzed the current management status and trends at home and abroad, explored the related issues of human genetic resources data management, and provided reference for further promoting and standardizing the management of human genetic resources data in my country.Methods:This article analyzed the current management status of human genetic resources data from three levels: relevant policies, management frameworks, data platforms and sample databases through literature review and expert consultation and policy research.Results:Countries paid more and more attention to human genetic resources, and the construction of my country′s human genetic resources management system is constantly advancing and improving. In the data era, the management of human genetic resources was facing new problems and challenges, requiring further strengthening the research and management of relevant data.Conclusions:At present, the management of human genetic resource data in my country needs to be strengthened. On the one hand, it is necessary to promote the implementation and coordinated management of specific systems on human genetic resources data. On the other hand, it is necessary to strengthen the effective protection and sharing of human genetic resource data.

Objective:To analyze the problems in human genetic resource management in the field of stomatology and explore corresponding strategies.Methods:By organizing and analyzing stomatological projects related to the disclosure of information on human genetic resources by the Ministry of Science and Technology, combined with literature analysis and interviews with research management leaders, the problems in human genetic resource management in stomatological institutions were summarized and management strategies were proposed.Results:61 projects were approved for the utilization of human genetic resources in the field of stomatology, showing an increasing trend year by year. Among them, 43 projects were approved by stomatological institutions as the team leader unit; There are problems in the management of human genetic resources in stomatological institutions, such as insufficient resource development and utilization, urgent development of biological sample banks, and incomplete resource sharing mechanisms. The interview results show that the management of human genetic resources needs to be improved, and the management departments and professional management personnel, system construction, and training need to be strengthened.Conclusions:Stomatological colleges and institutions should comprehensively coordinate the management of human genetic resources, establish a sound management system, strengthen the construction of biological sample banks, expand shared resources through multiple channels, fully utilize human genetic resources for research, and promote the high-quality development of stomatology.

Objective:According to the international cooperation project of Peking University Cancer Hospital on human genetic resource management practices, combined with the development direction of human genetic resource management laws and regulations, and propose reference suggestions for medical institutions to strengthen human genetic resource management.Methods:Sort out the projects that Peking University Cancer Hospital obtained international cooperation approval on the government platform of the Ministry of Science and Technology from July 2019 to June 2023, analyze the current situation of human genetic resource management in the hospital, summarize the challenges brought by the implementation of new regulations on human genetic resource management in medical institutions, and propose corresponding suggestions.Results:A total of 1276 international cooperation projects on human genetic resources have been approved, including 345 initial declarations and 931 change declarations. Involving 453 studies, including 286 clinical trials of drugs or devices on the market, accounting for 63.13%, and 100 clinical trials of Phase I drugs, accounting for 34.97% of the market studies. On average, there are 3.14 changes per project for listed research, and 1.56 changes per project for non listed research.Conclusions:Regulations on the Management of Human Genetic Resources ( short for Rules) limit the management scope of international cooperation projects involving human genetic resources and delegate management authority to medical institutions. Adjusting the scope of application for international cooperative clinical trial filing may result in some administrative approval projects being transferred to filing. The approval process for international cooperative scientific research projects on human genetic resources has been adjusted. Suggest medical institutions to strengthen the management of samples and intellectual property outside the scope of application of Rules.Strengthen the entire process management of international cooperation in scientific research. Pay attention to and timely communicate the dynamics of human genetic resource management.

Objective:To construct a scientific and technological evaluation system based on the needs of the pilot program for building a national high-quality hospital and establishing a national medical center.Methods:Xiangya Hospital of Central South University gradually improved its academic evaluation system by following the guidelines outlined in national authorities′ documents regarding "abolishing the five only" and "setting new standards", adhering to the guiding principles of "quality, contribution, efficiency, and impact" and employing the principles of "high-standard evaluation, quantitative evaluation, representative work evaluation, and third-party evaluation" .Results:The hospital established a comprehensive, scientific, and quantifiable indicator pool. These indicators were applied to various aspects of medical innovation evaluation, including awarding incentives, discipline assessment, professional promotion, personnel assessment, mentor selection for graduates, and excellence evaluation. Simultaneously, the hospital developed an intelligent platform for medical innovation evaluation and assessment in university-affiliated hospitals based on performance management theory.Conclusions:Through the construction and practice of the Xiangya technology evaluation system, the hospital further improved and optimized its academic evaluation work, guiding researchers to high-quality innovation and efficient translational research, ultimately promoting the high-quality development of the hospital.

Objective:As China′s new drug review and approval system continues to evolve, clinical trial management procedures are being continuously promoted and refined. This article aims to identify key review points for clinical trial establishment reviews and offer recommendations for optimizing the review process.Methods:By combining the regulatory requirements for clinical trial establishment management and the unique situation of our institution, the status of establishment approval applications upon initial submission and challenges encountered during establishment approval reviews were analyzed. The factors that may affect the likelihood of initial approval for establishment applications, and the elements and standards involved in clinical trial establishment approval reviews were studied.Results:From 2020 to 2022, the hospital received a total of 514 clinical trial establishment applications for registration purposes, with a first-time approval rate of 30.2%.Whether an application served as a team leader unit or a single-center clinical trial significantly impacted its likelihood of initial approval ( P<0.05). In clinical trial establishment reviews, drug clinical trials were most commonly associated with issues regarding sponsor qualifications, drug labeling, CRA qualifications, and drug testing reports. For medical device clinical trials, the most common issues were related to PI GCP certificate expiration dates, CRA qualifications, sponsor qualifications, and inspection reports. Conclusions:To enhance the quality and efficiency of clinical trial establishment reviews, it is recommended that trade organizations publish guidance documents on key points for clinical trial establishment reviews. Additionally, it is essential to enhance communication and collaboration among institutions, sponsors, and CROs and provide more training for relevant personnel, to jointly promote a more streamlined and effective clinical trial establishment review process.

Objective:Analyze the operation mode of the valuation investment of scientific and technological achievements in hospitals, and provide a certain reference for other hospitals to carry out valuation investment in scientific and technological achievements.Methods:This paper analyzed the origin and current situation of the valuation investment of scientific and technological achievements. Taking Peking University Cancer Hospital as an example, it made an in-depth analysis of the valuation investment model of scientific and technological achievements.Results:The study found that the valuation investment of scientific and technological achievements in hospitals includes several key links such as signing the Valuation Investment Agreement, signing the Shareholder Agreement and the Articles of Association, the registration and identification of technical contracts, the issuance of invoices, and deferred taxation. And several suggestions on how to apply this model for the transformation of scientific and technological achievements were put forward.Conclusions:Although the implementation process of scientific and technological achievements is cumbersome, the operation mode is diverse, and the ownership of equity is difficult to distinguish, the advantages are extremely obvious. It can closely combine technological capital and industrial capital, form a strong and effective technological alliance and a community of multiple interests, better use the market-oriented motivation of scientific and technological innovation, and carry out cutting-edge research in line with market prospects.

Objective:The Capital′s Funds for Health Improvement and Research (referred to as ″CFH″), established to address clinical medical issues, have been operating for over a decade. This study aims to comprehensively evaluate the achievements of this fund and provide empirical support and recommendations for optimizing the operational model of the clinical research fund.Methods:An online questionnaire was used to investigate the following aspects of CFH: subject area, the person in charge, derived projects, theses, patents, transformation of results, and popularization and promotion.Results:A total of 745 projects were collected through the online survey, and after rechecking for outliers, 720 completed projects were ultimately included. The top three disciplinary domains, in terms of the number of completed projects, were oncology, cardiovascular diseases, and neurological disorders. The age distribution of project leaders exhibited a left-skewed pattern, with a median age of 45 years. 319 (44%) received support from other related projects subsequently. 95% of the projects resulted in paper publication. 211 (29%) projects applied for patents and copyrights, with 141 projects being granted patent authorization. 78 (11%) projects successfully achieved technology transfer, with transfer and licensing being the most common modes. 156 (22%) projects disseminated their outputs, often targeting secondary hospitals and community health institutions.Conclusions:CFH aligns with local needs, and the outputs are substantial. In the future, consideration can be given to establishing an evaluation mechanism, increasing efforts to promote high-quality outputs, strengthening the organizational model set by the project guidelines, and further improving the rolling support mechanism.

Objective:Taking the experience of patent and achievement transformation management at the Shanghai Children's Medical Center affiliated with Shanghai Jiao Tong University School of Medicine as a reference, to explore the innovative strategies for hospital intellectual property and achievement transformation management.Methods:An in-depth statistical analysis was conducted on the patent authorization, maintenance, and transformation data of the institute since its inception, to gain a comprehensive understanding of the current state of patent management and achievement transformation, identify prevalent issues, and propose potential solutions.Results:The maintenance rates of invention patents and utility model patents within 5 years were 92.31% and 88.24% respectively, while the conversion rates were 3.92% and 0.56% respectively, with an average duration of maintenance of 3.06 years and 2.99 years. All expired invention patents were terminated due to unpaid annual fees. By 2033, the cost of maintaining all patents at the institute is expected to rise from 20 000 yuan in 2023 to 35 400 yuan.Conclusions:The key challenges in managing scientific and technological achievements at the institute include low patent maintenance rates, limited achievement transformation, and the absence of registered technology licenses. In the future, it is suggested to enhance the support for patent application and maintenance, promote scientific and technological achievement transformation, ensure effective technology license registration and filing, gradually cultivate a positive atmosphere for intellectual property and achievement transformation, cultivate high-value patents, and prioritize effective achievement transformation.

Objective:To identify the strengths and weaknesses of hospital development through the application of individual scientific research performance assessment, thereby providing a basis for the formulation of science and technology policies.Methods:We established a research performance assessment system and conducted research performance assessments across the hospital for three consecutive years. The assessment results were analyzed in-depth, utilizing the Kruskal-Wallis test to determine if there were differences in the overall level of assessment scores between years and series; the Mann-Whitney test to analyze differences between the promoted and non-promoted groups; the χ2 test to analyze whether age, degree, gender, and maternity situations affected assessment grades. Results:From 2020 to 2022, the individual scientific research performance assessment scores showed an overall upward trend, with the average per capita assessment score increasing significantly from 35.26 points in 2020 to 74.04 points in 2022. There were statistical differences in the assessment scores of different professional titles, indicating that the senior professionals > the associate senior professionals > the intermediates. There was no significant difference between the promoted and non-promoted groups. Additionally, age, degree, gender, and maternity factors affected assessment grades.Conclusions:It has been preliminarily established that the assessment of individual scientific research performance can effectively steer the scientific innovation activities of researchers, and play a positive role in enhancing the overall scientific research strength. The findings from the data analysis indicate that the hospital is expected to continuously enhance its scientific research performance by focusing on newly recruited doctoral personnel, establishing a system of support and guidance, and providing preferential support to female researchers. The assessment results serve as a " benchmark" for management departments and provide data-driven insights for the development of science and technology policies.