RESUMO
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.
RESUMO
To meet China′s requirements for scientific and technological innovation and high-quality development in the new era, it is imperative to actively implement the innovation-driven development strategy and build high-level research hospitals. Beijing Friendship Hospital, Capital Medical University has been working to build a research hospital since 2018. The hospital promoted discipline construction through the development mode of discipline clusters, made the research wards as a platform, adopted the " shared comprehensive service" mode to improve the quality and efficiency of clinical research, and strengthened talent cultivation through such key measures as a new talent recruitment system. The mode has proved successful in such aspects as improving the ranking of scientific and technological value of hospitals and disciplines, introducing high-level talents, and outputting scientific and technological achievements, supporting by research wards for other departments of the hospital, and improving the efficiency and quality of clinical trials. Such a mode can provide reference for general hospitals in building research hospitals.
RESUMO
According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.
RESUMO
Objective:To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.Methods:This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.Results:At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.Conclusions:Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.
RESUMO
Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.
RESUMO
ABSTRACT Introduction: Technical movements that mainly include running and jumping are soccer's main sport selection processes. These technical movements demand high requirements of lower limb endurance and explosive strength by athletes. Objective: Study the methods of strength and explosive force training in the lower limbs of soccer players. Methods: The experiment with 40 volunteers lasted 12 weeks and was conducted as a control experiment. The experimental group performed extensive lower limb strength training represented by weight resistance strength training on Monday and Wednesday. In contrast, the control group performed traditional modes of strength training such as half squats and deep squats. Diet was controlled, targeting to minimize the interference of unrelated variables. Results: The scores of the experimental group and the control group were improved and statistically more favorable in the experimental group. Conclusion: The strength training system with weight bearing on the lower limbs used in this study may promote better muscular development of the athletes, improve the explosive power of their lower limbs, and allow better performance on the field, and may be replicated. Level of evidence II; Therapeutic studies - investigation of treatment outcomes.
RESUMO Introdução: Os movimentos técnicos que incluem principalmente a corrida e o salto são os principais processos de seleção esportiva no futebol. Estes movimentos técnicos exigem altos requisitos de resistência dos membros inferiores e força explosiva pelos atletas. Objetivo: Estudar os métodos de treinamento da força e da força explosiva nos membros inferiores dos jogadores de futebol. Métodos: O experimento com 40 voluntários durou 12 semanas, sendo conduzido na forma de um experimento de controle. O grupo experimental realizou um amplo treinamento da força nos membros inferiores representado pelo treinamento da força de resistência ao peso na segunda e quarta-feira, enquanto o grupo de controle realizou os modos tradicionais de treinamento da força, como meio agachamento e agachamento profundo. A dieta foi controlada visando minimizar a interferência de variáveis não relacionadas. Resultados: As pontuações do grupo experimental e do grupo de controle foram aprimoradas, estatisticamente mais favorável no grupo experimental. Conclusão: O sistema de treinamento de força com sustentação de peso nos membros inferiores utilizado neste trabalho pode promover melhor o desenvolvimento muscular dos atletas, melhorar o poder explosivo de seus membros inferiores e permitir um melhor desempenho no campo, podendo ser replicado. Nível de evidência II; Estudos terapêuticos - investigação dos resultados do tratamento.
RESUMEN Introducción: Los movimientos técnicos que incluyen principalmente la carrera y el salto son los principales procesos de selección deportiva en el fútbol. Estos movimientos técnicos exigen grandes requisitos de resistencia de los miembros inferiores y fuerza explosiva por parte de los atletas. Objetivo: Estudiar los métodos de entrenamiento de la fuerza y la fuerza explosiva en las extremidades inferiores de los futbolistas. Métodos: El experimento con 40 voluntarios duró 12 semanas, realizándose en forma de experimento de control. El grupo experimental realizó un extenso entrenamiento de fuerza de las extremidades inferiores representado por el entrenamiento de fuerza de resistencia con pesas los lunes y miércoles, mientras que el grupo de control realizó modos tradicionales de entrenamiento de fuerza como la media sentadilla y la sentadilla profunda. La dieta se controló con el objetivo de minimizar la interferencia de variables no relacionadas. Resultados: Las puntuaciones del grupo experimental y del grupo de control mejoraron, siendo estadísticamente más favorables en el grupo experimental. Conclusión: El sistema de entrenamiento de fuerza con carga de peso en los miembros inferiores utilizado en este estudio puede promover un mejor desarrollo muscular de los atletas, mejorar la potencia explosiva de sus miembros inferiores y permitir un mejor rendimiento en el campo, y puede ser replicado. Nivel de evidencia II; Estudios terapéuticos - investigación de los resultados del tratamiento.
RESUMO
Objective:To survey the status quo of community practice bases for general practice residency training in Wuhan city.Methods:A questionnaire survey was conducted in 12 community general practice training bases affiliated to 11 tertiary hospitals in Wuhan city from March to June 2021. A total of 123 general practice residents and 41 instructors participated in the survey using the different questionnaires. The contents of questionnaires included the basic conditions of the training base and the current status of training at community base, as well as their satisfaction on the program and related problems. The statistical analysis was performed with SPSS software.Results:The conditions of the 12 primary practice bases met the requirements of the Standard for Standardized Training Bases for General Practice Residents (2019 Revision) in terms of size of community hospitals, qualification of the person in charge and faculty team. The survey showed that only 3 bases had psychiatric department; 7 bases had literature retrieval system; all 12 bases had a teaching secretary, but only 1 had a full-time teaching secretary; all 12 bases had established formal assistant relationship with higher-level hospitals, but the frequency of communication was low in some bases. Survey also showed that 68.3% (28/41) instructors were aged 40-50 years; 90.2% (37/41) of instructors participated in epidemic prevention and control; 36.6% (15/41) thought that instructing work was related to professional promotion; 87.8% (36/41) of instructors were generally satisfied with the work performance. Most of trainees (92.7%, 114/123) were satisfied with the training at the primary base, and there was a difference in satisfaction degree between trainees with different enrollment sources (χ 2=6.92, P=0.032). The proportion of trainees with confidence for future career increased from 39.8% (49/123) before training in community bases to 60.2% (74/123) after training. Conclusions:The survey shows that primary practice bases for general practice residency training in Wuhan have met the basic requirements; however, the evaluation and motivation of teachers need to be improved, the opportunities for trainees to practice in general outpatient clinics should be increased, research and teaching need to be emphasized, and the management of trainees needs to be strengthened.
RESUMO
Objective:The management system of Investigator Initiated Clinical Trials (IIT) using human genetic resources in large hospitals is still not optimal. The purpose of this study is to sort out the existing problems of human genetic resources management in IIT of large hospitals, analyze the management practices, and provide reference for the standardized management of human genetic resources in IIT.Methods:The existing problems of human genetic resources management in IIT of large hospitals were sorted out by literature analysis, and the management practices since the establishment of human genetic resources management office were analyzed, and suggestions were put forward.Results:The problems of human genetic resources management in IIT of large hospitals mainly focused on the lack of awareness and attention of investigators and managers, the lack of process supervision, and the imbalance between input and output of genetic resources. A large hospital has implemented personnel and system construction, strengthened node management and control, and developed a training system. The approval rate of administrative approval and archival projects of human genetic resources of the Ministry of Science and Technology in 2021 increased by 52.69% compared with the previous year.Conclusions:Large hospitals should proceed from the actual situation, establish the human genetic resource management system jointly through multi-department linkage, improve management process, strengthen quality control, increase training efforts, improve the professional capacity and quality of researchers and managers, promote the high-quality, high-level and well development of IIT.
RESUMO
Human genetic resources are an important strategic resource for the development of science and technology in China. In order to fully utilize and effectively protect human genetic resources in real-world studies, through analyzing the status and characteristics of real-world studies, this study found that the number of real-world studies was increasing year by year, and with some characteristics, such as many uncontrollable factors, strict requirements for evidence formation, and easy information acquisition and disclosure. Combined with the characteristics of real-world studies, the ethical issues of human genetic resource management in real-world studies were summarized into three aspects, including scientific and value of research development, informed consent and privacy protection of subjects, and fairness and justice in benefit sharing. Accordingly, the key points of ethical review were proposed as scientific rationality, fully informed consent and privacy, as well as data security and stakeholders. In addition, it is necessary to give full play to the role of ethical review in research access and process supervision responsibilities, guide researchers to make full use of human genetic resources by strengthening training and process management, and further promote the standardization of real-world studies.
RESUMO
Objective:This article analyzes the cognition and satisfaction evaluation of patients in medical alli-ance. Under the medical alliance mode,the present study tries to explore the choice of medical treatment of patients, the first diagnosis of primary health care institutions and its influencing factors, in order to provide reference for the construction of medical alliance. Methods:With the help of stratified sampling method,eighteen (18) medical alli-ances were selected from 16 districts and counties in Beijing. The survey questionnaire was designed to be used as the tool for data collection. A total of 1 280 patients in medical alliance participated in this study. The Chi-square Test and binary logistic regression model were used for statistical analysis. Results:59.12% of patients understand the medical association and related policies. 39.12% of the patients are satisfied with the medical association,51.44% of patients are willing to take first diagnosis at primary health care institutions. The distribution of medical resources in various districts is uneven. The type of hospital visited,the degree of understanding of medical alliance,the expe-rience of medical alliance and the satisfaction toward medical alliance will have an impact on the willingness about basic initial diagnosis,and the influence make a significant statistical sense. Conclusions:The Medical alliance con-struction in Beijing has achieved a certain effect,as first visit at primary health care institutions will be the initial for-mation. But the unbalanced distribution of medical resources in various districts,the service capacity of primary care institutions which does not meet the needs of patients,the insufficient sensitization of relevant policy and the current health insurance policy are seen as limiting factors to the development of medical alliance.
RESUMO
Objective:In this study,through the description of understanding,behavior,evaluation about med-ical alliances,we explore the problems and made recommendations to medical alliances. Methods: A questionnaire survey was conducted on 556 medical staff in 18 medical alliances in Beijing. We used descriptive statistical methods to analyze the situation of cognition and so on. And we compared medical staff evaluation of medical alliances be-tween core hospital and cooperative hospital. Results: Only 5.40 % of medical staff are totally unaware of the medical alliances policy. 38.73 % of the doctors don't conduct two-way referral. 55.69 % of the doctors in the core hospital don't come to the cooperative hospital. 71.40 % of the medical staff think that the operation of the medical alliances is good. There are big differences in the distribution of overall evaluation between core hospital medical staff and cooperative hospital medical staff by rank sum test. Conclusion: The understanding of medical alliances and the evaluation of activities are better. However, the two-way referral effect is not obvious and some specific activities are not ideal.
RESUMO
<p><b>AIM</b>To study the constituents of the root of Gypsophila oldhamiana Miq.</p><p><b>METHODS</b>Silica gel column chromatographic technique was used for the isolation and purification of compounds. The structures were elucidated on the basis of spectral data and chemical evidences.</p><p><b>RESULTS</b>Five compounds were obtained and identified as the beta-D-glucoside of alpha-spinasterol (I), tetracosyl caffeate (II), sucrose (III), beta-sitosterol (IV) and daucosterol (V).</p><p><b>CONCLUSION</b>Compound II is a new compound. Compound I was isolated from this plant for the first time.</p>