Data integrity, accuracy, and traceability are key elements of high-quality clinical research, as well as weak links in the promotion of clinical research transparency. How to promote data quality has become a major concern to all clinical research stakeholders. In this article, we dissected and analyzed data generation and capturing process in clinical research, and identified a key aspect in improving data quality: to promote electronic source data, especially to break the barrier between electronic health records and clinical research systems. Additionally, we summarized the experiences regarding this issue in China and overseas to propose a solution suitable for China to improve data quality in clinical research: to strengthen clinical research source data management by building clinical research source data platform and adopt common source data management process in hospitals.
ObjectiveTo investigate the current situation of domestic registry studies, and to provide basis for future research.MethodsWorld Health Organization (WHO) registration platform, ClinicalTrials.gov registration platform and other registration platforms were searched to collect the registered registration studies in Mainland China from inception to July 31st, 2018. Two researchers collected and collated data, analyzed by descriptive statistical methods, and then python-igraph package in Python 3.5 was used to draw the network diagram.ResultsA total of 247 studies were retrieved, mainly for disease registry and pharmaceutical product registry. Cohort and case-series were the principally study design. The research focused on chronic diseases such as cardiovascular and cerebrovascular diseases, and research sites were based on the economically developed area, for example, Beijing, Shanghai and Guangdong. The network diagram of study design and disease system shows that cohort research design is widely used in the nervous system and circulatory system; the network diagram of the research sites and disease system found that Beijing mainly studied circulatory and nervous system diseases, Shanghai mainly studied circulatory system diseases, and Guangdong relatively studied more on nervous system and urinary system diseases.ConclusionThe increasing number of registry studies in China reflects the importance of long-term outcome assessment of diseases.
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.
ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
The research background, way of thinking, research contents and methods of a united research project - "The Clinical Research on the Treatment of SARS with Integrated Traditional and Western Medicine" were reviewed. The latest research achievements on the treatment of SARS with integrated traditional and western medicine and the difficult points in the research were discussed. Furthermore, some tentative ideas were put forward to further the research. The conclusion was drawn that the principles of evidence-based medicine and the research scheme of multi-centered, prospective and randomized controlled trials, as well as the standard statistical and analyzing methods are the best way to assess the effectiveness and safety of treating SARS with integrated traditional and western medicine.
Objective To investigate the clinical manifestations, lung function and therapy of patients with primary bronchogenic carcinoma complicated with chronic obstructive pulmonary disease ( COPD) . Methods 365 patients with primary bronchogenic carcinoma were recruited retrospectively. The patients were analyzed by COPD-complicated and COPD-free groups. The clinical manifestations, lung function ( especially FEV1 ) , pathological types and progression-free survival ( PFS) were analyzed. The use of inhaled corticosteroids for treatment of COPD was also recorded. Results There was 62.2% patients( 227 cases) complicated with COPD with an average age of ( 66.1 ±9.3) yrs, 77. 5% of male, 82. 4% of smokers, and 46. 3% of past histories of respiratory disorders. Those in COPD-free were aged ( 54.8 ±5.6) yrs, with 55.8% of male, 62.3% of smokers, and 30.4% of past histories of respiratory diseases. The COPD-complicated patients had lower lung function than that of COPD-free [ ( 68.6 ±9.7) % vs. ( 75.3 ±7.5) % in FEV1%pred and ( 65.9 ±8.5 ) % vs. ( 75.6 ±9.1 ) % in FEV1 /FVC, P lt; 0.05 ] . The COPDcomplicated patients were more likely to have squamous carcinoma ( 43.2% vs. 31.2% , P lt; 0.05) and small cell lung cancer ( 20.7% vs. 15.2% , P lt; 0.05) . Moreover, performance status ( PS) scores ( 3.3 ± 0.5 vs. 2.8 ±0.4) and PFS ( 5.9 ±1.6 vs. 7.5 ±2.1) were worse in the COPD-complicated patients than that of the COPD-free patients. Only 71 cases of the COPD-complicated patients received regularly inhaled corticosteroids for COPD treatment. These patients had better PS scores and PFS than others without corticosteroids treatment. Conclusions Primary bronchogenic carcinoma patients with COPD comorbidity are commonly encountered. Clinicians should be aware of the clinical manifestation and corticosteroids prescription should be recorded to improve the quality of life and prognosis.
ObjectiveTo use the evidence map system to search and sort out the clinical research on the prevention and treatment of hyperlipidemia with proprietary Chinese medicine, and to understand the distribution of evidence in this field. MethodsThe literature on the treatment of hyperlipidemia with proprietary Chinese medicines was retrieved from CNKI, WanFang Data, VIP, SinoMed, PubMed, Cochrane Library, Embase and Web of Science databases from inception to December 2022. The distribution characteristics of evidence were analyzed and presented by means of text and graph. ResultsA total of 865 articles were included and 79 kinds of proprietary Chinese medicines were obtained. The Xuezhikang tablets or capsules were the most frequently used. In recent years, the number of published articles showed a downward trend, and the literature quality was generally low. Most of the research intervention programs only used Chinese patent medicine, and the sample size of a single study was mostly 60-100 patients, and the study course was 4-8 weeks. Clinical studies did not highlight the characteristics of traditional Chinese medicine, and only 12.7% of the studies limited the syndrome type of traditional Chinese medicine in the study population. In terms of the selection of outcome indicators, more attention was paid to blood lipid levels and safety indicators, while less attention was paid to indicators such as traditional Chinese medicine syndrome scores. ConclusionThe results show that Chinese patent medicine has certain advantages in the prevention and treatment of hyperlipidemia, but there are some deficiencies in the reports of methodology and clinical characteristics, and the overall quality of the research is low.
In order to mediate the contradiction between the high quantity and low quality of Traditional Chinese Medicine (TCM) clinical research, to avoid blind research and waste of resources, and to promote the benign development of TCM clinical research, we proposed carrying out health research priority setting on the TCM clinical research. This paper defined the main content of TCM clinical research and briefly introduced the research status of priority setting methods. We described a five-step process of the TCM priority setting research: setting the research scope and plan, establishing the working group, mapping the research field, identifying priority research areas, reporting, evaluating and updating the research. It is expected that this area will receive the attention of relevant researchers, policy makers and research funders.