By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
ObjectiveTo explore the implementation of standardized training of general practitioners system in China. MethodsA total of 25 bases of training general practitioners and its collaborative community service centers, which were located in the east and western region of China, met the inclusion criteria; qualitative interviews and questionnaires were done between November 2012 and November 2013, including 456 teachers, 281 students, and 166 teaching management staff. Survey content involved implementation of standardized training system, teaching method and so on. ResultsSatisfaction rate of training general practitioners training system with teachers, students, and administrators was 76.2%, 71.3%, and 86.3%, respectively (χ2=92.372, P<0.001). The average satisfaction rate of training model, teaching programme, teaching materials, teaching arrangements, the examination system, the quality of training, and supporting policies was 95.7%, 92.1%, 73.8%, 65.7%, 72.5%, 86.8%, and 48.9%, respectively (χ2=813.196, P<0.001). Satisfaction rate of teaching method with teachers, students, and administrators was 81.1%, 74.4%, and 67.7%, respectively (χ2=40.159, P<0.001). ConclusionSatisfaction rates of training general practitioners training system and teaching method with teachers, students, and administrators are low. The main impact factors are:the syllabus and textbooks are not practical, qualified teachers are short, teaching arrangements is unreasonable, teaching content is specialization, government support is inadequate and so on.
摘要:目的:探讨临床教学的全程制度化管理及其效果。方法:通过健全组织,完善制度,加强教学、临床及实习生管理、建立激励机制等措施,进行全程制度化的规范管理。结果:教学质量显著提高,不良事件鲜见,无恶性事件发生。近来医院已有6篇教学论文公开发表,4个先进集体和8名先进个人受到医院表彰,5名优秀带教教师和8名实习生受到各学院奖励。结论:临床教学全程制度化管理是提高教学质量的切实有效途径。Abstract: Objective: To investigate system management during the entire clinical teaching process and its effect. Methods: To robust organization, perfect rules, strengthen management of clinical teaching and intern student, and establish encouragement mechanism,and other measures, so as to conduct standard system management during the entire process. Results: Quality of teaching improved notably, bad event was scarce, no malignant event occurred. There were six teaching articles issued publicly, four advanced collectives and eight advanced individuals had been praised by hospital, and five excellent teachers,eight intern students had been rewarded by each college. Conclusion: System management during the entire clinical teaching process is an effective way to improve teaching quality.
Objectives Through a systematic review, to summarize and describe various health security mechanisms of protecting financial risk from illness in low and middle income countries (LMICs), and to analyze causes that lead to different effects in financial risk protecting. Methods Search words were chosen by both health policy experts and search coordinators after discussion and pilot. Twenty-four electronic databases, websites of 11 health institutions, and the search engine Google were searched. Any original study to evaluate the role of financial protection of health security mechanism in LMICs was included. Pre-designed data extraction form was used for collecting strategies and study method of included studies, and extracted information was analyzed and described. Results Fifty-two studies were included, and 56 specific health security mechanisms were categorized into 6: community-based health insurance, social health insurance, health sector reform, subsidy, user fee, and new rural cooperative medical scheme (NRCMS) in China. Forty-two mechanisms had positive effect in financial protection, 6 were negative, 5 had no effect and the effect of the other 2 was unclear. Conclusion Mechanisms that produced positive effect can be summarized as: setting up of co-payment rate, design of benefit packages, providing free care for vulnerable population, delivering primary health care directly in remote area, and Chinese NRCMS. Mechanisms to protect the poor from financial risk of illness include: government provides health insurance, providing free care and setting up different co-payment rate according to income. The failure of health security mechanisms can be ascribed the deviation from its original goal of health security mechanism design, due to various inner or external causes.
From the perspective of the new institutional economics, the institutional change of hospital accreditation & evaluation in China was summarized and the experiences of hospital accreditation & evaluation from international organizations and other countries were refined to put forward the counter-measures for institutional innovations of accreditation & evaluation in China. First, it’s urgent for the government to issue the standards of hospital accreditation and discriminating hospital evaluation; second, these standards should pass the certification by the International Society for Quality in Health Care External Evaluation Association; finally, China should construct the commission on certification and accreditation administration for healthcare to supervise the social or third part organizations.