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Objective:This study is to understand the hot spots and trends in the recruitment of clinical trial subjects in China over the past 20 years, explore the existing problems and countermeasures, and provide scientific ideas for domestic clinical trial institutions to effectively solve the problem of subject recruitment.Methods:Bibliometric analysis was used to study the relevant literature from three major domestic databases from 2001 to 2021, analyzing key indicators such as annual publication volume, journal distribution, institutional distribution, regional distribution, and high-frequency keyword co-occurrence.Results:A total of 162 articles were selected. The results showed that the overall publication volume in this field showed an upward trend, and the research institutions were diversified, with a concentration of medical and pharmaceutical institutions and universities. The current research hotspots in this field focused on quality and efficiency improvement of subject recruitment, with themes of subject protection, ethical review, regulation development, standardized management, etc.Conclusions:The research in this field has made significant progress, but the overall research level is still relatively weak. Therefore, it is suggested that the country should play a role in macro-regulation, on the one hand, starting with top-level design, promoting the construction of a standardized management system for subject recruitment, continuously strengthening subject protection, and enhancing the effectiveness of scientific recruitment. On the other hand, releasing the potential of grassroots institutions and giving full play to the volume advantage by promoting the sinking of advantageous resources. Meanwhile, great importance should be attached to the development of Phase I clinical trials, giving full play to the strong internal energy of traditional medicine and promoting the development of Chinese traditional medicine. These multi-measures should provide a theoretical basis for exploring the transformation of ′clinical research hospitals′, and promote the high-quality development of new drug research and development in China.
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Objective:This study aims to identify and enhance management strategies for fostering the conversion of scientific and technological advancements in tertiary general hospitals in Beijing.Methods:A questionnaire survey was conducted to pinpoint and organize the areas needing improvement in the transformation process of scientific and technological achievements at Beijing Tiantan Hospital. This involved aspects such as organization, leadership, investment, incentives, and service guarantees. The data were then analyzed and summarized, taking into account the hospital′s management, research activities, and the specific circumstances of the institution.Results:The primary drivers for successful achievement transformation in Beijing′s tertiary general hospitals were identified across six key indicators: proficiency of professional and technical managers, allocation of special funds, access to market and industry resources, criteria for job title evaluation and promotion, a culture promoting diligence and fault tolerance, and comprehensive transformation training programs.Conclusions:The study concludes that implementing effective incentives and refining the institutional environment for innovation and transformation are crucial. Additionally, it′s vital to adjust work focus and enhance management in weaker areas, in line with the hospital′s actual situation. Moreover, boosting service efficiency and providing full life cycle services have emerged as pivotal measures to augment the efficacy of hospital innovation and transformation efforts.
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Objective:To understand main problems existing in the construction of advanced stroke centers in China and put forward solutions, for reference in promoting the standardization construction of advanced stroke centers and improving the efficiency of acute stroke treatment.Methods:The data were derived from relevant data of on-site export guidance in the construction of advanced stroke centers at 175 tertiary hospitals from 2020 to 2021, and the scores of on-site evaluation indicators for the establishment of stroke centers and their formal approval were compared and analyzed. Based on on-site investigation and expert consultation, the common problems existing in the construction of advanced stroke centers were summarized. All data were analyzed by descriptive analysis, the scores of on-site evaluation indicators were expressed by ± s, and paired t test was used for comparison between groups. Results:Compared with the total score(693.04±72.06) of on-site evaluation at the stage of project launch, the total score(747.94±78.10) of on-site evaluation for formal approval of stroke centers of 70 hospitals was higher, and the difference was significant( P<0.01). There were seven common problems in the construction of stroke centers in 175 hospitals, including insufficient attention paid by hospitals, lack of effective performance incentive policies, imperfect treatment procedures and medical norms, and so on. Conclusions:Experts on-site guidance plays an important role in the construction of stroke centers in China. At present, there were still problems to tackle in the construction of stroke centers in hospitals. In order to promote the standardized construction of stroke centers in China and improve the efficiency of stroke treatment, the authors suggest fuorther strengthening the importance attached by hospital leadership and the coordination and organization of functional departments, establishing stroke center models conforming to the actual situation of the hospital, seting up the post of brain and heart health manager, and improving the regional prevention and treatment level of acute stroke.
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After the completion of the pilot work of traditional Chinese medicine formula granules （TCMFGs）， the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work， this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards， mainly involving the executive standards and distinguishing technologies of raw materials， the adding process of excipients in the procedure item， the rationality of quality control methods， the information content and reproducibility of characteristic chromatograms， the nomenclature and accessibility of reference materials， etc. The common problems such as the coverage of standards， specification differences， and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards， accelerate the research and development of reference materials， advocate the use of high-quality raw materials， explore the evaluation methods of high-quality products， and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards， promote the continuous improvement of TCMFGs standard system， and ensure the healthy and orderly development of the TCMFGs industry.
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This study was based on the project prophase of expert consultation and literature consult, and aimed to analyze the medicine establishment from the perspective of traditional Chinese medicine (TCM) doctors, in order to further study the influence of medical insurance on the development of TCM. Detailed suggestions were made in or-der to promote the benign development trend of TCM and medical insurance. Questionnaire survey was used in the investigation on perceptions of TCM related with medical insurance among 253 TCM doctors in appointed medical institution of medical insurance. Data was processed with frequency statistics. The results showed that after becoming the appointed medical institution of medical insurance, the medical insurance patients have become the main service group (73.5%) of hospitals (68.4%) and incomes of TCM doctors (41.9%) have increased, which contribute to TCM hospitals of becoming bigger and stronger (63.6%). The medical insurance patients have chosen TCM treatment main-ly for its curative effect (37.9%) and safety (24.1%). The influence of reimbursement ratio in medical insurance was relatively low (1.2%). The reimbursement range of TCM medical insurance needs to be further expanded, such as Chinese medicine nosocomial preparation (90.5%), decoction preparation fee (78.3%), and etc. It was concluded that under the background of universal health coverage, medical insurance plays a more and more important role in the development of TCM. And TCM should ensure its safety and improve its curative effect through the standardization of TCM and other measures. Meanwhile, the formulation of medical security policy and medical insurance management service standards should also consider the characteristics of TCM, and encourage the service of TCM.