Objective To analyse the content and structure of the health management policy text for chronic obstructive pulmonary disease (COPD) in China, and to provide a reference for the optimization and improvement of subsequent relevant policies. Methods We searched for relevant policy documents on COPD health management at the national level from January 2017 to December 2023, constructed a two-dimensional analysis framework for policy tools and chronic disease health management processes, coded and classified policy texts, and used content analysis method to analyze policy texts. Results Twenty-four policy texts were included. There were 183 codes for policy tool dimension, with supply based, environmental based, and demand based tools accounting for 43.72%, 47.54%, and 8.74%, respectively. There were 124 codes for the dimension of health management processes, with health information collection and management accounting for 12.10%, risk prediction accounting for 14.52%, intervention and treatment accounting for 66.13%, and follow-up and effectiveness evaluation accounting for 7.26%. Conclusions At present, the proportion of policy tools related to the management of COPD in China needs to be dynamically adjusted. Environmental tools should be appropriately reduced, the internal structure of supply tools should be optimized, the driving effect of demand tools should be comprehensively enhanced, the coupling of COPD health management processes should be strengthened, and the relevant policy system and overall quality should be continuously improved.
ObjectiveTo analyze the limitations and challenges for the use of real-world data in the decision making of drug reimbursement through literature review and provide standard process and guideline for the real-world study supporting drug reimbursement. MethodsBy summarizing the relevant policies, regulations, and guiding principles of major drug regulatory agencies worldwide, the study analyzed the applicable conditions, framework, and reimbursement mode for using real-world evidence in the decision making of drug reimbursement. ResultsThe study found that the health technology assessment departments of major developed countries and Asian countries have used real -world evidence to evaluate the drug efficacy and safety. The application scope of real-world data for reimbursement decision included describing the treatment process of the disease, assessing economic burden, verifying economic models, and evaluating the efficacy and safety of drugs. Some developed countries including the United Kingdom and the United States had released guidelines or frameworks of the real-world study for reimbursement decision. The process and framework of using real-world data in reimbursement decision could be divided into three models: coverage with evidence development, outcome-based contract, and re-assessment. ConclusionReal-world data has been widely used in the process of health technology assessment. To adapt to the development of the pharmaceutical industry and to meet the needs of clinical patients, it is urgent to standardize the process of collecting real-world data and formulate the scope and process of using real-world data in the reimbursement process.
National Center for Medical Service Administration of National Health and Family Planning Commission of China was established at the beginning of 2015. It is mainly in charge of developing and managing standards of medical technology and organizing their implementation, and giving technical guidance and consulting for evaluation of medical institutions. The foundation of the center fills in the blank of lacking central administrative department of the guideline development and evaluation. This paper introduces the definition and the function of clinical practice guideline, and analyzes the current situation, problems and challenges of domestic guidelines, and proposes some potential suggestions on improving the quality of Chinese guidelines from national level for promoting the standardization, scientification and transparency of clinical practice guidelines in China.
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.
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.
ObjectiveTo analyze the policy environment of clinical research in China, providing valuable insights for the formulation and enhancement of policies. MethodsAt the national level in our country, policies related to clinical research were selected as the research subject. The method of text mining was employed to extract high-frequency words from policy texts. By constructing the policy modeling consistency (PMC) index model, evaluations of the relevant policies regarding clinical research in our country were quantified from multiple dimensions including internal consistency, effectiveness, and scope of influence. ResultsThe average PMC index of 22 clinical research policies in our country was 6.87. Among them, 10 policies demonstrated an excellent performance, while 12 policies were considered qualified. This suggested that the overall quality of clinical research policies at the national level was good, yet there was still considerable room for improvement. ConclusionPolicies regarding clinical research have entered a high-speed development stage and exhibit basic completeness in China. However, these policies appear somewhat independent of each other and inadequate rule of law.
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.
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.
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.
Real-world evidence represents critical evidence to support post-marketing drug monitoring, assessment and policy decisions, and has received extensive attentions. However, an explicit over-arching design and conceptual framework for this specific area is lacking. Divergent opinions on the production of real world evidence are often present among researchers; and understanding about their implications also differ among policy makers and evidence users. In this article, we have proposed, from the regulatory and clinical perspectives, a conceptual framework on the use of real world data for post-marketing drug studies, assessment and policy decisions.