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.
ObjectiveTo explore the application of enhanced funnel plots (EFP) and trial sequential analysis (TSA) in robustness assessment of meta-analysis results.MethodsData were extracted from published meta-analysis. The EFP was used to evaluate the robustness of the significance and heterogeneity of the current meta-analysis. The TSA was used to judge the sufficiency of the cumulative sample size of the current meta-analysis and to assess the robustness of conclusions based on current evidence.ResultsThe EFP showed that the meta-analysis results of low-density lipoprotein (LDL) was robust, and the meta-analysis results of triglyceride (TG), total cholesterol (TC) and high-density lipoprotein (HDL) were not stable. The TSA showed that the cumulative sample size of LDL had reached the required information size (RIS), and the current conclusion was stable. The cumulative Z value of TG, TC and HDL neither reached the RIS nor passed through the TSA monitoring boundary or futility boundary, indicating that current conclusions were not robust.ConclusionsThe combination of EFP and TSA can make a comprehensive judgment on the robustness of current meta-analysis results, and provide methodological support in the robustness assessment of results for future systematic reviews and meta-analyses.
The robustness of results of statistical analysis would be altered on the condition of repeated update of traditional meta-analysis and cumulative meta-analysis. In addition, the cumulative meta-analysis lacks estimation of the sample size. While trail sequential analysis (TSA), which introduces group sequential analysis in meta-analysis, can adjust the random error and ultimately estimate the required sample size of the systematic review or meta-analysis. TSA is performed in TSA software. In the present study, we aimed to introduce how to use the TSA software for performing meta-analysis.
The sample size of a meta-analysis should not be less than a single randomized controlled trial. Trial sequential analysis (TSA) can provide required information size and monitoring boundary to justify the conclusion of meta-analysis. However, the TSA software is only suitable for binary and continuous data, and it cannot analyze the time-to-event data. This paper aimed to introduce how to analyze the time-to-event data using TSA approach.
ObjectiveTo analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials, and to analyze the progress and shortcomings of health Qigong-related clinical trials.MethodsChinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15st, 2020. Characteristics of trials were analyzed in the aspects of basic information, funding source, study content and more. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).ResultsA total of 121 registered clinical trials were included. The annual registration quantity has been increasing with a peak (33.06%) reached in 2020. Among the registered trials, Baduanjin exercise- related studies accounted for the highest proportion (65.29%). The quantity of studies registered in Shanghai accounted for the most (29.75%). The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (5.79%). 50.83% funds in trials were originated from universities and hospitals. Type 2 diabetes, and chronic obstructive pulmonary disease were the most studied diseases in the registered trials. 90.08% trials were designed as randomised parallel control studies, and the sample sizes of trials were concentrated between 30 and 100 (71.07%), and the age of the subjects was distributed over 40 years old (46.15%). The average quality of registration completion of the two registries was 87.44%.ConclusionsAt present, the general trend of health Qigong clinical research is positive. However, these trials contain unbalanced attributes such as the research type of health Qigong, distribution of registration area and organization, allocation of funds, and age composition of subjects. The design of clinical trials and registration details are needed to be improved.
It is potential for N-of-1 trials to evaluate economics of health care, however, it is still in the exploratory stage. With the advantage of accurate estimation of costs and effects, it is beneficial to promote the application of N-of-1 trials for economic evaluation in the era of precision medicine. In this study, we introduce the necessity, feasibility, selection, calculation of indicators and influence factors of N-of-1 trials for economic evaluation, and in order to provide references for researchers to perform related studies.
ObjectivesTo analyze the research status and hot spots of hypertension-related clinical trials in special Chinese population registered on the Chinese Clinical Trial Registry (ChiCTR), so as to provide a basis for the development of hypertension-related research in special population in China.MethodsThe ChiCTR was searched online (up to August 31st, 2019, no limitation in the status of trial registration), all clinical trials on hypertension in special population were collected, and the general characteristics, researched diseases, research types, intervention measures and main outcomes of the trials were analyzed.ResultsA total of 64 hypertension-related clinical trials in special population registered in the ChiCTR were included, including 41 (64.1%) trials registered in last 3 years. The registration status of 46 (71.9%) trials was pre-registration. The registered authors were mainly from colleges and universities or medical institutions (n = 61, 95.3%), of which 60.9% were registered in Beijing, Shanghai, Guangdong, Zhejiang, Jiangsu and Hebei. The researched diseases mainly included elderly hypertension and hypertensive stroke, accounting for 50% of the total. Additionally, 37 (57.8%) clinical trials were intervention studies, of which 21 (56.7%) were drug-based intervention studies. Blood pressure, blood glucose, cardiovascular and cerebrovascular events, blood lipid, cranial MRI and Glasgow Coma Scale were the commonly used outcomes, accounting for 58.5% of the total outcomes. Most blood pressure measurements did not indicate the measurement method (n = 22, 64.7%).ConclusionsThe quantity of hypertension-related clinical trials in special population registered on the ChiCTR is increasing, however, there exists regional imbalance. The drug intervention-related clinical trials of elderly hypertension have become a research hot spot. However, blood pressure measurement method is not indicated in most trials, and some researchers do not register in time. Therefore, it is suggested that researchers should further strengthen the awareness of carrying out high-quality clinical trials.
Objective To evaluate the quality of the registration information for trials sponsored by China registered in the WHO International Clinical Trial Registration Platform (ICTRP) primary registries or other registries that meet the requirements of the International Committee Medical Journal Editor (ICMJE). Methods We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale. Results The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry – India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scoreda median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points). Conclusion Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.
ObjectivesTo analyze the metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.
Based on evidence-based medicine (EBM) and from the viewpoint of providing scientific evidence for clinical application, we found that Traditional Chinese Medicine (TCM) was short of adequate evidence to support its therapeutic effects due to lack of high quality clinical research. Data management plays a very important role in clinical research. Lack of adequate data management may lead to low quality clinical research. Thus, it is of great importance to establish a set of standards for data management so as to improve the quality of clinical research. Based on the real practice in Myocardial Infarction Secondary Prevention Study in TCM (MISPS-TCM), this article introduces methods on data audit in clinical trials of TCM.