ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
Informed-evidence decision-making (IEDM) has emerged as the predominant principle of providing guidance for policy-making and practice, however, the best available evidences requisite of performing successfully IEDM. Different forms of evidence and different kinds of review questions call for the development of new approaches that are designed to more effectively and rigorously identify and synthesize the evidence. Fourteen methods of reviewing literature have been recently used to identify and synthesize evidence, of which scoping reviews is increasing popular. This article introduces aspects such as background, purpose and methodological frame work and explains the process of it with an example so that facilitating the dissemination and utilization of scoping review in China.
As an important part of social governance, the health poverty alleviation plays a key role in promoting Healthy China Strategy. This paper reviews the practice progress of health poverty alleviation in China, and summarizes it's four action logics. It is found that the governance effect is restrained by several issues, such as pessimistically external governance environment, single governance subject, poor leading role of the pilot areas, specific practices inconsistent with conceptions, and the research has not paid enough attention to the incentive system and supervision mechanism of the practitioners. Based on the above, this paper proposes five governance principles on the governance of health and poverty alleviation: evidence-based principle, systematic principle, economic principle, dynamic principle and people-oriented principle. Lastly, we hope to provide some preferences to promote the governance practice of health poverty alleviation.
Objective To evaluate the related laws, regulations and guidelines about off-label drug use in several countries, so as to provide evidence for regulating off-label drug use in China. Methods The following 3 Chinese databases as CBM, CNKI and VIP, 11 foreign databases including EMbase, PubMed and so on, 15 countries’ official websites of pharmaceutical administration department or academic organization, and WHO website were searched to obtain the related laws, regulations and guidelines about off-label drug use. By adopting the system evaluation method and self-defined index evaluation, the quality of the included literatures was evaluated in three aspects: literatures’ type, content relevance and timeliness. Seven researchers independently extracted data by Excel which included basic information of literatures, preconditions of off-label drug use, medicines categories that could be off-labelly used, regulations and legal responsibility in off-label drug use. And finally the descriptive analysis was conducted. Results A total of 4 735 literatures were retrieved, 104 of which were finally included, including 89 at grade A quality level (85.58%) and 15 was at grade B (14.42%). The analysis showed that, a) Seven countries had laws related to off-label drug use: America, Germany, Italy, Netherland, New Zealand, India and Japan. Except India, the rational off-label drug use was allowed in the other 6 countries. The right to prescribe off-label drug was defined in Britain and Ireland; b) Medical staff had to take the responsibility of off-label drug use in the country where the duty regulations were formulated; and c) Ten countries published guidelines or statements related to off label drug use by their official departments and academic organizations. And the regulation included the following procedures: firstly, to obtain the relative information and evidence; secondly, to get the informed consent; thirdly, to be approved by the ethics committee and/or pharmacy administration committee; fourthly, to record the reasons and effectiveness of off-label use; fifthly, to monitor the adverse reactions of off-label drug use. Besides monitoring the medical institutes, the pharmaceutical companies had also be monitored which included the following 3 aspects: a) to require companies to train specialized staffs to answer the questions related to off-label drug use; b) to open the contact information of medical departments of companies; and c) to prohibit preaching and advertising the off-label drug use. Conclusion Off-label drug use has its rationality and necessity. To protect the safety of patients, avoid the risk for hospitals and medical staffs, it requires formulating relative regulations soon in order to manage the off-label drug use in China. As a developing country, China is different from the developed countries in health care system. Therefore, when formulating the regulations, it is necessary to perform evidence-based evaluation on each country’s laws, regulations and guidelines about off-label drug use, with Chinese national conditions and experts’ opinions in combination. After a regulation is preliminarily drawn up, it needs to be put into pilot practice, and then revised and spread to the whole country.
To introduce the definition, applicable scenarios, methodology and examples of mixed methods systematic reviews, aiming to promote the application of mixed methods in China and to help clinical decision-makers to select appropriate qualitative results from systematic reviews to guide clinical practice.
Objective The modification of Chinese patent medicines (CPM) instructions is currently the focus of national drug regulation, with policies and regulations being established. Nevertheless, the policies pertaining to CPM instructions have not been thoroughly investigated. This study analyzes the direction and current issues with existing policy items to give a reference for future optimization and adjustment of policies linked to CPM instructions. Methods The official website of the National Medical Products Administration (NMPA) and National Health Commission (NHC) were searched to collect policy documents related to the CPM instructions issued at the national level in China from January 1st 2000 to June 1st 2024. Based on the classification of policy tools (supply-based policy tools, demand-based policy tools, environment-based policy tools) and the dimension of policy development (policy planning, policy implementation, policy supervision, and policy evaluation ), a two-dimensional analytical framework of "policy tools and policy process" was constructed by using the content analysis method and the quantitative analysis method, and policy documents were analyzed. Results The 27 policy texts included in the analysis generated 104 policy entries in total, wherein, environment-based policy tools (74.04%) were used the most in the dimension of policy tools, followed by demand-based policy tools (24.04%) and supply-based policy tools (1.92%). In the dimension of policy development, policy planning tools, policy implementation tools, policy supervision tools, and policy evaluation tools accounted for 24.04%, 52.88%, 17.31%, and 5.77%, respectively. An in-depth analysis of the content of the policy entries discovered that the existing policy took into account the specification of the content of the instruction and the standardization of the expression of writing, the instruction application guidance, etc, and more and more attention was being paid to the content of the characteristics of TCM in the instruction. Conclusion Currently, there is an insufficient amount of policy documents on CPM standards, which are overly focused on environment-based policy tools and the policy implementation process. To achieve the policy goal of regulating and applying CPM specifications, it is recommended to create a balanced and coordinated structure of policy instruments, emphasise the direct promotion and pulling effect of supply and demand, increase the weight of policy evaluation and supervision, and develop a standard system for evaluating CPM specifications.
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
In the context of actively coping with aging, China has introduced a series of health care integration policies. Using the advocacy coalition framework theory, this paper aims to analyze the process of health care integration policy changes in China from three dimensions: policy beliefs, external events and policy learning. The policy subsystem of health care integration in China includes two coalitions: top-down cascade promotion and bottom-up absorption and radiation. External events and policy learning triggered policy change, where policy learning included endogenous learning within the coalition and exogenous learning between the coalitions. A policy impasse occurs when the two advocacy coalitions are at odds, and policy brokers and professional forums can get rid of the policy impasse. In the process of policy change in China’s health care integration, the two major advocacy coalitions have reached a certain consensus. It is recommended to alleviate the problems in the integration of health care by strengthening the external factors in the change of health care policy, enhancing the policy learning in the change of health care policy, and making full use of the information resources in the change of health care policy, so as to promote the high-quality development of the integration of health care.
China has accumulated abundant experience on how to deal with post-disaster mental problem in recent years. However, the relevant concepts about post-disaster mental health services, detailed contents and process of the services were still incomplete. In order to provide guidance for the implementation of post-disaster mental health services, optimize service process, and improve service experience, the development of management practice of post-disaster mental health service is warranted. The authors give some suggestions on developing the management practice.
Objective To systematically review and conclude the healthcare reform policy in rural China throughout the past 62 years. Methods This study was applied with PICOS structure to formulate research issues. National/ministry policies and documents on healthcare reform in rural China were systematically collected. The primary healthcare issues and healthcare reform measures carried out at each stage were studied, and, the criteria as population healthcare indicators, indicators for healthcare workforce and infrastructure in rural areas, healthcare expenditure indicators, and the results of national surveys for healthcare service were used to evaluate the reform performance achieved at each stage. Results A total 396 national policies on healthcare reform in rural China were included through comprehensive search. In accordance with the results of quantitative analysis on literatures, characteristics of economy system reform at each stage as well as actual advancement on healthcare reform, the reform courses of healthcare system in rural China in this study were divided into six periods as follows: national economy recovery and adjustment period, cultural revolution period, early stage of economy system transition, initial stage of healthcare reform, middle stage of healthcare reform, and implement stage for new rural cooperative medical system (NRCMS). The average policies of each period increased year by year, which generally showed as features as laying more emphasis on medical services than medicine, and thinking little of medical insurance. The population health indicators, sickbeds per thousand rural population and medical practitioners kept improving gradually. Yet the import of market mechanism and influence of international economy condition led to the decline in public welfare of healthcare system, increase of personal expenditure proportion among general healthcare cost, and duplicate content among some polices.Conclusion Commonwealth orientation is the fundamental principal to fulfill healthcare service system, thus performance on policies should be concluded in combination with the present national conditions, future requirements as well as evidence-based policy-making, and additionally, such performance should be improved during implementation.
