The BMJ Launches Landmark 'China Medical Research' Collection: Advancing Evidence-Based Health Policy and Practice under Healthy China 2030

On February 5, 2018, The BMJ published an article titled “Medical Research in China”"China Album"” and accompanied it with an editorial. This marks the first time in its 170-plus-year history that The BMJ has published a “China Special Issue,” specially invitingLeading Authoritative Experts in Medical-Related Fields in ChinaA series of analytical articles on the current hotspots in Chinese medical research has been published, with VCBeat (WeChat ID: vcbeat) releasing curated highlights of the core viewpoints.

The BMJ is the journal of the British Medical Association (BMA), one of the world’s three major medical associations. Together with the New England Journal of Medicine (NEJM), The Lancet, and the Journal of the American Medical Association (JAMA), it is recognized as one of the “world’s four top-tier general medical journals.”

The four articles in this “China Special Issue” highlight China’s latest advancements in “Healthy China 2030,” “clinical practice guidelines,” “real-world evidence,” and “medical big data.” They provide readers with a comprehensive, systematic, objective, and authentic overview of the development, opportunities, and challenges in these fields, as well as China’s future-oriented vision and global leadership in healthcare.

Since General Secretary Xi Jinping proposed“Without health for all, there can be no comprehensive well-being.” From the convening of the National Conference on Health and Healthcare Work, to the release of the Outline of the “Healthy China 2030” Planning Program, and further to the explicit proposal in the Report to the 19th National Congress of the Communist Party of China to implement the Healthy China Strategy, health, as a national development goal and strategy, is not only a top-level decision made by the Party and the state, but has also become an important component of the “Chinese Dream” pursued by the general public.

Achieving the strategic goals of Healthy China is inseparable from medical innovation, knowledge translation, evidence-based practice, and scientific decision-making.This timeThe BMJ commissioned an article titled “Chinese Medical Research” because high-quality medical research forms a continuous loop from data to evidence, then to clinical guidelines and health policy formulation, ultimately improving health outcomes. Rigorously designed, properly conducted, and fully reported medical studies are the cornerstone of evidence-based clinical practice and the basis for health policy development.

How to efficiently and rationally leverage high-quality, multi-dimensional, large-scale data to generate robust, traceable real-world evidence; employ scientific, systematic, and transparent methods to develop clinical guidelines that enhance healthcare quality and improve patient health outcomes; provide information and evidence for national health policy formulation; thereby facilitating the translation of research findings into policy-making and clinical practice, and addressing the unbalanced and inadequate development in China’s healthcare sector.It is a common challenge facing healthcare professionals, medical researchers, and health policymakers across China.

China, with its vast territory and large population, has achieved world-renowned economic and technological successes since the reform and opening-up. Medical research in China is undergoing rapid transformation. The government attaches great importance to the health of all citizens,"Prioritizing Public Health as a Strategic PriorityStrong support and sustained investment in medical research have driven rapid development and impressive scientific output in China’s medical research sector. At the same time, however, Chinese medical research faces numerous structural challenges and difficulties. The medical community must seize opportunities, identify systemic solutions, and promote continuous innovation in health, thereby effectively translating research findings into health policy formulation and clinical practice. This will serve the goal of health for all and demonstrate China’s comprehensive development and progress as an emerging major power. The BMJ will continue to focus on China’s medical reforms and development through its “China Collection.”

“Without health for all, there can be no comprehensive well-off society.” The Outline of the “Healthy China 2030” Plan (hereinafter referred to as the “Outline”), as the most important national health development policy for the current and foreseeable future, aims to promote healthy lifestyles, improve medical services, and optimize the health industry. It seeks to establish a sustainable basic medical and healthcare system covering both urban and rural residents by 2020, and by 2030,The institutional framework for promoting health for all has been further improved, with major health indicators reaching the level of high-income countries, fully reflecting General Secretary Xi Jinping’s concept of “prioritizing people’s health in national development strategies.”. In the face of slowing macroeconomic growth and numerous challenges, the formulation of the Outline must take into account multiple complex factors.

Healthcare financing and security mechanisms are crucial for ensuring the equity and accessibility of medical services, holding profound significance for achieving universal health coverage and the goal of building a moderately prosperous society in all respects. In their article, Director Fu Wei, Dr. Zhang Yuhui, and their colleagues from the Health Development Research Center of the National Health and Family Planning Commission focused on the core indicator of the proportion of out-of-pocket personal health expenditure within total health expenditure. They applied a component-based forecasting model to predict the future scale and composition of total health expenditure, proposing targets to reduce the share of out-of-pocket personal spending to 28% by 2020 and to 25% by 2030. After extensive deliberation and validation, these research findings were submitted to the National Health and Family Planning Commission and were ultimately incorporated into the Outline.

Since the 1980s, changes in China’s health financing policies have led to a rapid increase in the out-of-pocket medical expense burden on individuals. The share of personal health expenditure in total health expenditure soared from 21.2% in 1980 to 60% in 2001. Since then, the Chinese government has implemented a series of healthcare reforms to alleviate the financial burden of seeking medical care among the population and to ensure the equity and accessibility of medical services. China’s “12th Five-Year Plan” for Health Development explicitly included the share of personal health expenditure as one of its development indicators, setting a target to reduce this share to below 30% of total health expenditure by 2015. During the “12th Five-Year Plan” period, health insurance coverage expanded significantly, government health spending increased substantially, and the financial burden of seeking medical care among the population decreased markedly. Compared with 2001, the share of personal health expenditure in total health expenditure dropped from 60% to 28.8% in 2016.

Nevertheless, the financial burden of medical expenses persists, and poverty induced by illness has not yet been eradicated. The Outline explicitly sets specific targets for the proportion of individual out-of-pocket health expenditures within China’s total health expenditure. On one hand, this provides indicators to monitor and safeguard populations against medical financial risks; on the other hand, these indicators serve as benchmarks for comparison across different periods. When combined with data on the actual economic burden of healthcare utilization among the population, equity in health financing, and population health indicators, they can be used to evaluate, adjust, and improve government policies related to health investment and health insurance coverage. Policy formulation is a complex process. As China’s most important national-level health action plan, the Healthy China 2030 Planning Outline has ushered in a new era of evidence-based policymaking and advanced the modernization of the governance system and capacity in the health sector.

China has the largest patient population globally, yet it faces relatively insufficient medical resources, suboptimal service quality, and significant variations in clinical practice across different regions and hospitals. Furthermore, China is the only country in the world where traditional Chinese medicine (TCM) and Western medicine are practiced in parallel across primary, secondary, and tertiary healthcare institutions. How to fully leverage the respective characteristics and advantages of TCM and Western medicine to serve physicians and patients more effectively remains a current challenge. Clinical practice guidelines play an important and positive role in addressing these issues. In the article “Clinical Practice Guidelines in China: Current Status, Challenges, and Opportunities,” Professor Chen Yaolong and Professor Yang Kehu from the Evidence-Based Medicine Center at Lanzhou University/WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, along with Academician Wang Chen, President of the Chinese Academy of Medical Sciences and Peking Union Medical College, provide an in-depth analysis of the current status of clinical practice guidelines in China, advancements in methodological research, and challenges in the field of implementation.

The results indicate that the number of clinical practice guidelines (CPGs) in China has grown rapidly in recent years. Currently, approximately 100 CPGs are developed and published annually by professional societies and associations across various medical and healthcare fields, while the number of published expert consensus statements is several times higher than that of CPGs. However, according to the authoritative Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument, there remains a significant gap in the quality of Chinese CPGs compared with those from Europe and the United States, particularly in the domains of systematic review evidence citation, management of conflicts of interest, and formulation of recommendations. Meanwhile, the authors provide detailed examples to illustrate under what circumstances Chinese guideline developers should adopt or adapt high-quality international guidelines, and when they should opt to develop entirely new domestic guidelines. Whether directly adopting, adapting, or developing new guidelines, it is essential to adhere to rigorous methodological standards, advocate for prospective guideline registration, promote transparency in the adaptation and development processes, standardize the full-text reporting of guidelines, and mitigate the influence of academic and commercial interests.

The article concludes by proposing five strategies and recommendations for Chinese guideline developers, researchers, and health policymakers to improve the development and implementation of clinical guidelines in China. These include: guideline developers should thoroughly understand, evaluate, and analyze the quality and recommendations of existing domestic and international guidelines; guidelines should be developed in accordance with internationally standardized methods and processes; methodological research on guidelines should be strengthened, including reporting standards and registration systems; a national-level platform and system should be established for the evaluation, inclusion, dissemination, and implementation of guidelines, along with management of conflicts of interest and quality oversight; and active exchange and collaboration with international guideline development organizations and evidence-based healthcare bodies should be enhanced to draw on valuable foreign experience in guideline development, implementation, and research. These recommendations offer significant insights and have positive practical implications for advancing the development and implementation of clinical guidelines in China that align with international standards while integrating local evidence and practice. The article concludes that although scientific, impartial, high-quality evidence-based guidelines free from conflicts of interest are not a panacea for all clinical problems, they remain one of the most effective tools to help patients and healthcare professionals in China combat disease.

Real-world evidence has garnered extensive attention and interest both domestically and internationally within the fields of health research and health policy. Real-world evidence refers to a broad category of research conducted by applying various epidemiological methods to real-world data. Sources of real-world data are diverse, including routinely collected healthcare data, traditional observational studies, spontaneous adverse drug event monitoring, administrative databases such as death registries or health insurance claims, and data collected via personal devices. Real-world studies and the resulting evidence can provide critical support for advancing clinical practice, improving healthcare quality, developing clinical practice guidelines, post-marketing drug evaluation and surveillance, research and development of medical technologies and products, and determining the scope of health insurance coverage.

In the article “Real-World Evidence: Chinese Experience and Insights,” Professor Sun Xin, Director of the Chinese Cochrane Center at West China Hospital, Sichuan University; Director Li Xinling from the Center for Drug Reactions Monitoring under the China Food and Drug Administration; and their colleagues discussed the development and application prospects of real-world studies in China, and clarified widespread misconceptions about real-world evidence both domestically and internationally. They particularly emphasized that real-world studies are not a research type entirely opposed to traditional clinical trials; rather, there is continuity between the two in terms of study characteristics. Meanwhile, real-world studies are not equivalent to observational studies; as real-world characteristics increase, the external validity of the study gradually strengthens.

The article also points out that the generation of real-world evidence (RWE) in China is still in its early stages. However, driven by rapidly growing demand and high-level national prioritization, the field has advanced rapidly. Notably, the China Hospital Pharmacovigilance System (CHPS), launched in 2015 by the National Center for Adverse Drug Reaction Monitoring under the China Food and Drug Administration, leverages existing drug risk analysis and evaluation tools to monitor and assess adverse drug reactions within hospitals, ultimately generating real-world evidence on drug safety to inform decision-making. Another significant initiative is the establishment of the Chinese Network for Health Policy and Technology Assessment Research, which utilizes retrospective data and public surveillance data to generate evidence on disease burden, clinical benefits, and harms, thereby supporting the evaluation of innovative or high-cost healthcare technologies.

The article further proposes a series of recommendations to enhance the quality and value of real-world evidence (RWE) in China, including: national authoritative bodies should strengthen the management of data sources and establish a policy framework; foster a research community that promotes collaboration between academic institutions and stakeholders; enhance talent development and build research capacity; and increase research funding to support the development of related infrastructure as well as new technologies and methodologies. Ultimately, these measures aim to enable RWE to more effectively advance evidence-based medical practice and inform policy decision-making in China.

Over the past decade, the volume of data generated, collected, and stored in the medical field has grown exponentially, accompanied by a rapid increase in the capacity to analyze and interpret these data. The integration of “big data” with emerging technologies has the potential to bring about profound changes in clinical practice, healthcare delivery models, and health policy, attracting widespread attention. Medical practitioners, researchers, policymakers, and industry stakeholders worldwide have demonstrated considerable enthusiasm for healthcare big data.

China’s large population and its unified national healthcare security system provide distinct advantages for the development of health and medical big data. In their article “Big Data and Medical Research in China,” Professor Zhang Luxia, Executive Deputy Director of the Peking University Health and Medical Big Data Research Center; Researcher Wang Haibo from the Clinical Research Center of the First Affiliated Hospital of Sun Yat-sen University; and Academician Zhan Qimin, Dean of the Peking University Health Science Center, among others, provide a detailed discussion on the definition of “big data.” They cite the authoritative “5V” framework, which characterizes big data by its Volume, Velocity, Variety, Veracity, and Value.

The article highlights that promoting the application of health big data in the healthcare sector is a significant national strategy for China. China is comprehensively advancing the use of health and medical big data at the national level to drive profound changes in healthcare delivery models, stimulate momentum and vitality for deepening healthcare system reforms, enhance the efficiency and quality of health services, expand resource supply, meet the multi-level and diverse health needs of the population, and foster new business formats and economic growth points. Currently, there are numerous major projects supported by the state, such as the "National Pilot Project for the Construction of Health and Medical Big Data Centers and Industrial Parks" launched by the National Health and Family Planning Commission, and the key special project on "Precision Medicine Research" under the National Key R&D Program initiated by the Ministry of Science and Technology. In addition to government-led research initiatives, Chinese medical research teams and institutions have also launched academic projects for data sharing. To better leverage health big data, it is essential to address effective data interoperability among different medical institutions, establish a medical terminology system more aligned with Chinese clinical practices, systematically improve population follow-up mechanisms, enhance data quality, and promptly introduce relevant policies and regulations to protect personal privacy and ensure data security.

The series of articles, along with their authors and affiliations, are listed below (in no particular order):

v Commentary:

· Chinese Medical Research Amid Rapid Transformation: Opportunities and Challenges Coexist

 (China’s medical research revolution)

Wu Yangfeng1, Yin Daoxin2, Kamran Abbasi2

1. Peking University Clinical Research Institute, School of Public Health, Peking University

2. The BMJ, London, UK

v Analyze the article:

· The Role of Research in Health Policy Formulation in China: A Case Study of the Target Setting for the Share of Personal Health Expenditure in the "Outline of the Healthy China 2030 Plan"

 (Research in health policy making in China: out-of-pocket payments in Healthy China 2030)

Wei Fu1, Shuli Zhao2, Yuhui Zhang1, Peipei Chai1,3, John Goss3

1. National Health and Family Planning Commission’s Health Development Research Center

2. Department of Finance, National Health and Family Planning Commission

3. University of Canberra, Australia

· Chinese Clinical Practice Guidelines: Current Status, Challenges, and Opportunities

(Clinical practice guidelines in China)

Yao-Long Chen1,2, Chen Wang3, Hong-Cai Shang2, Ke-Hu Yang1,Susan L. Norris 4

1. Evidence-Based Medicine Center, Lanzhou University; School of Basic Medical Sciences, Lanzhou University

2. Key Laboratory of Chinese Internal Medicine, Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine

3. National Clinical Research Center for Respiratory Diseases, Center for Respiratory Medicine, China-Japan Friendship Hospital

4. Secretariat of the WHO Guidelines Review Committee, Geneva, Switzerland

Note: Wang Chen's current affiliation is the Chinese Academy of Medical Sciences & Peking Union Medical College.

· Real-World Evidence: Chinese Experience and Insights

(Real world evidence: experience and lessons from China)

Sun Xin 1, Tan Jing 1, Tang Li 1, Guo Jianfei 2, Li Xinling 3

1. Chinese Evidence-Based Medicine Center, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University

2. James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, Ohio, USA

3. China Food and Drug Administration Center for Drug Adverse Reaction Monitoring

· Big Data and Medical Research in China

(Big data and medical research in China)

Lu-Xia Zhang1,2, Hai-Bo Wang3,4, Quan-Zheng Li5, Ming-Hui Zhao1,6, Qi-Min Zhan7

1. Department of Nephrology, Peking University First Hospital & Peking University Institute of Nephrology

2. Peking University Health and Medical Big Data Research Center

3. Clinical Research Center, The First Affiliated Hospital of Sun Yat-sen University

4. S&P Medical Information Research Center

5. MGH & BWH Center for Clinical Data Science, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA

6. Peking University- Tsinghua Center for Life Sciences

7. Peking University Health Science Center

Original article link: http://www.bmj.com/medical-research-china