With the accelerated development of research hospitals and research wards,higher requirements and more demands have been put forward for research doctors,as an emerging profession and position,research doctors are the main body and core force for organizing clinical research,ensuring and improving the quality of clinical research,and the collaborative innovation and transformation of medicine,and also the talent reservoir to promote the collaborative development of medicine.At present,the development of research doctors has great development potential and upside but also has many difficulties and challenges,which have become a bottleneck for the development of research doctors.This paper elaborates on the development of research doctors in China and abroad,the differences between research doctors and clinicians,the responsibilities and requirements of research doctors,and the problems and difficulties in the development of domestic research doctors,so as to provide ideas and references for the ability training,career development and career planning of research doctors.

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.

依据 2023 年国家卫生健康委员会、教育部、科技部、国家中医药管理局联合发布的《涉及人的生命科学和医学研究伦理审查办法》,为优化伦理审查流程,为临床研究人员减负,提出了部分符合条件的情况下可以"免除伦理审查".这是国家在伦理审查管理办法中首次针对"免除伦理审查"的一个突破进展.回顾梳理了国内外关于免除审查的相关情况,重点针对免除审查的四种情况进行分析探讨,尤其是对免除审查中关于匿名化和个人敏感信息的理解进行讨论分析,并针对四种情况提出实践的建议,并结合伦理审查工作的实际情况,探讨建立关于免除审查的实践标准和流程,为相关医疗机构实施免除伦理审查提供参考.

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.

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.

人类遗传资源是科技发展的重要战略资源,为了充分利用和有效保护真实世界研究中的人类遗传资源,通过分析真实世界研究的现状及特征,发现真实世界研究的数量逐年增多,且具有不可控因素较多、证据形成要求严格、信息易获取与泄露的特征.结合真实世界研究的特征,将真实世界研究中人类遗传资源管理的伦理问题总结为研究开展的科学性与价值性、受试者的知情同意与隐私保护、利益分享中的公平与公正三方面问题,对应提出伦理审查要点为科学合理性、充分知情、隐私和数据安全及利益相关者.除此以外,应充分发挥伦理审查的研究准入与过程监管职责,通过加强培训与过程管理引导研究者充分利用人类遗传资源,进一步推动真实世界研究规范开展.

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.

Background In China, medical alliances (MAs) are a way of integrating medical resources. This study tries to identify the factors that influence the implementation of MAs, explore physicians' views on the MAs, so as to provide experience for the integration of international medical resources. Methods Physicians in district D and district F of Beijing were recruited by a self-reported questionnaire. Descriptive statistical methods and the Mann-Whitney U test were used to describe and contrast the physicians’ evaluations. Factor analysis was used to reduce dimensions and calculate the overall evaluation of physicians. Multiple linear regression was used to identify the influencing factors of MAs. Results A total of 1032 physicians participated in this survey and the evaluation of MAs in D district is better. Most physicians express a dissatisfied attitude toward MAs. Regional characteristics, seniority and age of physicians, cognition degree of MA policy, professional competence, income and benefits and job satisfaction of physicians affect the implementation of MAs. Conclusions Physicians undertake more unpaid tasks in MAs, resulting in lower satisfaction. MAs in developed regions can stimulate the enthusiasm of physicians through extra rewards. Besides, the medical competence of physicians in small hospitals was improved with the help of physicians from large hospitals in the region, so physicians in these areas have better evaluations. The findings suggest that governments should focus on the personal development of physicians and improve their policy cognition to facilitate the implementation of MAs. In conclusion, the implementation of MAs varies in regions and developed regions have a more obvious effect on improving the implementation effect of MAs.

目的:探索及评价电子知情同意(electronic informed consent)和受试者补助电子发放(electronic payment of subject compensation,简称2E)在新药临床试验中的应用情况.方法:在2项新药临床试验中应用2E技术.实施电子知情同意流程如下:在电脑端添加临床试验信息,受试者在个人手机端绑定注册,研究者进入临床项目后对该受试者进行电子知情,双方电子签名后生成电子知情同意书存档;实施受试者补助电子发放流程如下:受试者通过公众号绑定银行卡,临床研究协调员提交申请,研究者进行审核,系统管理员再次审核后发放补助.分别由工作人员和受试者对2E技术进行评价.结果:补助发放所需时间最短3 min,最长不超过24 h;工作人员和受试者对2E技术均给予好评.结论:2E技术可提高临床研究的速度和质量,使更多的受试者获益.

目的 探究在医院分类管理背景下北京市所有制形式和效率之间的关系,为提高医院运行效率及完善相关政策提供科学依据.方法 以医院实有床位数、卫生技术人员数为投入指标,总诊疗人次数、出院人数、床位使用率为产出指标,使用数据包络分析中假设规模收益可变模型、假设规模收益不变模型和Malmquist指数模型,对2013—2017年北京市营利性及非营利性医院进行静态、动态效率测算并比较.结果 营利性医院规模、医疗服务提供量均低于非营利性医院,营利性医院综合技术效率、纯技术效率均低于非营利性医院,但其规模效率高于非营利性医院,动态效率分析结果显示营利性医院的全要素生产率变动高于非营利性医院.结论 营利性医院应注重提升纯技术效率来获得效率的提升,即注重自身管理能力的提高、注重人才发展战略同时适度扩大规模来提升总体的效率,探索集团化和差异化发展,而非营利性医院更应注重规模效率的提升,控制规模不合理的增长.

目的 评价2项全国多中心的慢性乙型肝炎创新药临床试验中尝试应用电子知情同意和受试者补助电子发放(2E)技术的满意度.方法 参加2项肝病创新药临床试验的受试者及工作人员作为研究对象.分别针对受试者及工作人员设计调查问卷,采用问卷星的形式发放调查问卷,重点针对电子知情同意和受试者补助电子发放的满意度及相关评价进行调查分析.结果 上述2个项目的入组受试者中发放25份问卷,回收23份,有效回收率为92.0％;工作人员共发放28份问卷,回收24份,有效回收率为85.7％.申办方、临床协调员、受试者及研究者对2E技术均给予好评,受试者对2E的满意度分别为95.7％和87.0％,工作人员对2E的满意度均为100％.结论 与传统知情同意及受试者补助发放相比,受试者及工作人员对2E的整体满意度高;通过扩大2E应用范围和完善功能,可提高临床研究的速度和质量,并使更多的受试者获益.

随着信息化社会的高速发展,越来越多的临床试验开始应用电子知情和电子支付等信息化手段,优化临床试验流程.电子知情和电子支付在临床试验中的应用给伦理审查带来了全新的挑战,伦理审查的要点和关注点有别于传统纸质流程,并且目前对电子知情和电子支付的伦理审查指南仍是空白.通过总结首都医科大学附属北京友谊医院开展临床试验电子知情和电子支付伦理审查经验,分析针对电子知情和电子支付的伦理审查要点,总结出其与传统流程的伦理关注点异同.探讨伦理视角下电子知情和电子支付在提高临床试验质量和效率方面的作用,未来伦理审查趋势及实际运行过程中可能存在的伦理问题及伦理监管.临床试验中应用各种信息化手段是必然趋势,这需要伦理委员会不断提高伦理审查能力,总结经验最终形成审查共识或指南.

目的:分析北京市住院医师规范化培训基地(含协同医院)的效率情况.方法:运用DEA方法,选取临床技能模拟训练中心面积、师资人数、培训基地经费为投入指标,培训人数为产出指标,对北京市51家住培基地进行效率分析.结果:北京市各住培基地综合技术效率、纯技术效率、规模效率平均值为0.37、0.60、0.68,其中三类效率均有效的医院共有4家.按不同分类看,综合技术效率和纯技术效率最高的是部队医院;规模效率最高的是市属医院.从投影值结果看,各住培基地均呈现产出不足的情况.结论:北京市各住培基地都应该在维持现有投入的情况下,尽可能的完善培训的教学设施,在场地有限的情况下利用各种现代化的模拟手段提高使用效率,增加住培医生的培养人数,同时严格制定带教老师的选拔标准,提高带教老师质量与水平.

Background To improve the efficiency of the use of medical resources, China has implemented medical alliances (MAs) to implement a hierarchical diagnosis and treatment system. The willingness to undertake a first visit to primary care institutions (PCIs) is an important indicator of the effect of this system. Beijing has also built MAs since 2013, but to date, there have been few studies on the first visit to PCIs in Beijing. The purpose of this study is to analyze patients’ willingness to make their first visit to PCIs and its influencing factors to provide references for the realization of a hierarchical diagnosis and treatment system. Methods Two relatively different districts with large differences in resources in Beijing, D and F, were selected, and a self-reported questionnaire and convenience sampling method were applied. A cross-sectional survey was administered to 1221 patients of MAs. The chi-square test and binary logistic regression were used to analyze the influencing factors of patients’ willingness to undertake a first visit to a PCI. Results Fewer patients in District D received medical alliance services (44.42%) than those in District F (59.25%), but patients in District D had a higher degree of satisfaction with the services they received (72.04%) than those in District F (28.96%). Patients in District D had a higher willingness to undertake a first visit (64.00%) than those in District F (58.18%). Patients of an older age, low medical expenses, participation in urban employees’ basic medical insurance, a high understanding of MAs and high satisfaction with medical services were indicators of being more willing to choose primary care institutions for their first visit. Conclusions The different medical resources and MA constructions in the two districts have resulted in a difference between the two districts in terms of the willingness of individuals to make their first visit to PCIs. Strengthening the service capabilities of PCIs remains a priority. The government should propose solutions to solve the problems encountered in practice and actively promote the realization of MAs and hierarchical diagnosis and treatment.

目的 分析医院患者满意度的关键驱动因素,为提升患者就医体验提供科学依据.方法 自行编制满意度调查问卷,在2018年7月采用简单随机抽样法对某医院的518例患者进行问卷调查,使用重要性矩阵分析方法,明确患者满意度的关键驱动因素.结果 该医院在“护士技术操作”和“护士服务态度”这两个条目处于优势,处于劣势的是“就诊流程顺畅”“收费合理性”“后勤服务”“就诊或住院环境”“设施设备种类与数量”与“医生诊疗水平”.结论 处于劣势的这6个条目对满意度的影响较大,且满意度得分较低,是患者满意度的关键驱动因素,因此今后的改革应集中在进一步优化就诊流程,提高医生诊疗水平,改革后勤服务以及加强医院设施、环境建设.

Background: To promote the integration of medical resources, Beijing has built medical alliances since 2012, but this reform has not changed the state of disordered medical treatment. Patients are still willing to go to high-level hospitals for medical treatment. What causes patients to prefer high-level hospitals? To explore the reasons behind this preference for high-level medical treatment among patients and to guide patients to make visits in an orderly manner, we conducted this study and compared patients' satisfaction with hospitals of different levels in the context of medical resource integration. Methods: This study conducted a questionnaire survey among 1,250 patients who were selected in 18 medical alliances in Beijing from October to December 2016. The study type is a comparative study based on cross-sectional data. Patient satisfaction was the main outcome, and descriptive analysis, chi-square tests, nonparametric tests and binary logistic regression analysis were used. The level of statistical significance was set at p<0.05. Results: The overall satisfaction score of the medical alliances was 3.375, and the satisfaction scores of core hospitals and cooperative hospitals were 2.77 and 3.07, respectively. The overall patient satisfaction rate was 44.62%, and the satisfaction rates of core hospitals and cooperative hospitals were 34.34% and 50.43%, respectively. The type of hospital and understanding of medical alliance policy were the factors associated with patient satisfaction with the medical alliance. Conclusions: The patients’ satisfaction with cooperative hospitals was higher than their satisfaction with core hospitals. Although the patients were more satisfied with the service attitude of the cooperative hospitals, they still preferred core hospitals due to their higher expectations for their medical treatment and greater trust in their medical technology. It is necessary to explore the establishment of closed medical alliances under the unified management of human and financial resources to enable medical alliances to become a community of common interests and provide integrated medical services for patients.

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.

[目的]描述我国健康产业园区基本现状,总结园区发展模式,为园区未来发展提供理论基础.[方法]利用百度搜索、CNKI和万方数据库全面搜索国内健康产业园区的相关信息和文献资料,基于文献内容分析法和案例分析法对园区信息进行归纳与分析.[结果]共检索到健康产业园区35个,涉及18个省市,最早的园区于1994年创办,园区平均面积为16.82 km2,平均投资金额为140.9亿元.从管理运营、投融资、产业类型、研发方面归纳了园区的不同发展模式,发现园区建设中的问题并提出未来发展趋势.[结论]我国健康产业园区正在蓬勃发展,但是仍然存在重复建设缺乏特色,监管机制尚不完善等问题,还需政府进一步完善审批、优惠等政策,引导园区健康发展.

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.

目的 探讨我国分级诊疗政策不足,为健全我国分级诊疗政策给予借鉴和参考.方法 采用内容量化分析法,并从政策工具类型、时间序列和医疗服务提供方角度构建了三维分析框架,深入分析时间阶段和医疗服务提供方在政策工具使用上的差别.结果 共检索到34项政策,其中2016年我国分级诊疗政策数量最多,共发布9项.全部编码数量为294条,其中象征和劝诫型工具128条、命令型工具90条、能力建设型工具52条、系统变化型工具24条.政策文本中涉及三级医院次数有54次,二级医院85次,基层医疗机构147次.结论 我国十分重视分级诊疗制度建设,政策工具体系已初步形成,但尚缺乏评估评价机制.应适当增加命令型和能力建设型方面的政策工具,不同医疗服务提供方也应该调整政策工具使用结构,增加系统变化型工具从而加强机构间的合作,鼓励建立紧密型医联体.