In this essay, classical events and related characters in the developments of clinical trial methodology were searched and summarized. The 'first' and major methodological progresses in the milestone events of clinical trials were therefore presented. This study is purposed to delineate the historically vicissitudinous progress of the clinical trial with typical figures and events, study and analyze the profound background of the renovation of clinical research methods, and provide references for clinical and scientific researchers, health policy makers and medical students to comprehensively review the history of clinical trial.
ObjectiveTo analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). MethodsThe website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. ResultsA total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. ConclusionThe number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.
Objective To investigate the number of Chinese clinical trials and the completeness of registered information on the source of their funding. Methods We searched the five primary registers in the World Health Organization’s International Clinical Trial Registration Platform to identify Chinese clinical trials, calculated the number Chinese clinical trials with specific funding and evaluated the completeness of the information on the source of this funding. Results We identified 383 registered Chinese clinical trials, of which 219 (27 trials per year on average) were registered in clinicaltrials.gov, 94 in the Chinese Clinical Trial Register Center (113 per year on average), 62 in controlled-trials.com (12.4 per year on average) and 8 (1.6 per year on average) in the Australian and New Zealand Clinical Trials Registry. 360 trials had some information on their source of funding: 230 from the mainland of China (62 funded by colleges/universities, 47 by national/local organizations, 47 by the Ministry of Science and Technology, 34 by hospitals, 28 by commercial organizations, 9 by international foundations, and 3 by the Ministry of Health), 117 from Hongkong and 13 from Taiwan. The information in the registers on the source of funding was incomplete. Conclusion The number of funded Chinese clinical trials in these registers is too small. The registrations should be improved to improve the completeness of information on the source of funding. It is important to disseminate the importance of registering clinical trials and doing so in a local register to promote the transparency and accessibility of trial registration.
In the clinical trials, the rights and interests of participants must be considered. Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants. Whether a clinical trial is in accordence with the ethics depends on if the available clinical evidence is valuable and credible. The better candomize controlled trial (RCT) is one of the best evidence which will make different results equal between the treatment group and the controlled group. Thus benefits and risks of participants are allocated equitably and useless treatment is prohibited when the effective treatment affirmed at the same time. Economic health evaluation and outcome measurements are emphasized in EBM, and the clinical evidence is updated regularly. It is EBM and its emphasis of evidence that need the high-quality clinical trials, therefore the problems of ethics involved in clinical trials is important.
ObjectivesTo explore the characteristics of Chinese methodological studies on patient compliance in clinical trials so as to provide reference for clinical trial of patient compliance in future.MethodsCNKI, VIP, CBM and WanFang Data databases were electronically searched to collect methodological studies on patient compliance in clinical trials published in Chinese language from January 2000 to December 2018. Two reviewers independently screened literature, extracted data and then, qualitative analysis of document characteristics was then performed.ResultsA total of 84 articles were included, in which 68 were studies on Western medicine and 16 were studies on traditional Chinese medicine (TCM). The results showed that: the quantity of studies on patient compliance increased along with time. However, those in TCM field did not increase. All included studies summarized their strategies to improve patient compliance, however key information for quality evaluation were missing.ConclusionsThere is still a lack of research on how to improve patients’ compliance in clinical trials to ensure the reliability of the results. Existing studies have not systematically and comprehensively explored the influencing factors of patients’ compliance. Clinical trials researchers in China have not focused sufficiently to patients’ compliance and lack the proper methodology to frame studies.
The quality of clinical trials is key to determine the value of a clinical research and whether it can transform achievements. In this paper, the characteristics and direction of the implementation of quality control in clinical trials in China, and the characteristics of quality control in clinical trials of Chinese medicine are discussed, and the development direction of quality control in clinical trials in China is explored in order to improve the overall level of clinical trials in China.
Objective To evaluate the efficacy and safety of Niuhuangjiangya tablets (NT) on mild to moderate primary hypertension (overabundant liver-fire) in comparison with Niuhuangjiangya pills (NP). Method The double-dummy and randomized controlled method was adapted to assess 240 patients (overabundant liver-fire) who were divided into the treatment group (n =120, treated with NT 2 tablets, twice a day) and the control group (n =120, treated with NP 1 pill, twice a day).The duration of treatment for both groups was 4 weeks. Results Blood pressure began to decline in the first week of treatment. After 4 weeks, the mean diastolic and systolic blood pressure dropped 7.51 and 12.16 mmHg, respectively, in the treatment group; 7.53 and 12.45 mmHg dropped respectively in the control group. For diastolic blood pressure, the total efficacy rates of the two groups were 50.8% and 54.9% (Pgt;0.05), respectively. For TCM syndromes, the total efficacy rates of the two groups were 45.6% and 42.34% (Pgt;0.05), respectively. The two drugs were equivalent by the equivalent test (Plt;0.05). No adverse effect was found in the study. Conclusions Niuhuangjiangya tablets have confirmed that the effects on mild to moderate hypertension has few side effects. The efficacy of the two drugs is equivalent by the equivalence test. placebo=controlled trials are required.
Statistical graph is an indispensable part of scientific papers. It is helpful to promote the communication, dissemination, and application of academic achievements by presenting research results intuitively and accurately through standardized and beautiful visual graphs. The safety of a medical intervention is the basic premise of its clinical application, and randomized controlled trial (RCT) as an important design to determine the efficacy and safety of medical interventions, it is extremely important to accurately present the information on the safety outcomes of interventions found therein. However, the research found that the reports of RCTs didn’t adequately use visual graphs to present harms data. In order to promote clinical researchers to better use visual graphs to present harms data, international scholars recently published a consensus study in BMJ, which identified and recommended 10 statistical graphs for presenting harms data in RCTs. In order to facilitate domestic scholars to understand and apply the consensus, this article interprets the consensus and recommendations, and it is expected to provide help for improving the quality of harms visualization in domestic papers of RCTs.
In recent years, clinical trial research on stroke intervention measures has been developing rapidly. In order to provide reliable conclusions, the outcome assessment of clinical trials is crucial. Tools for functional status evaluation have been widely adopted as outcome assessment, and have become mandatory for qualified clinical trials of stroke treatment. In this paper, the classification of functional assessment scales in stroke is reviewed, and the applications of functional assessment scales in clinical trials of stroke treatment are presented. National Institute of Health Stroke Scale, Barthel Index, and modified Rankin Scale are the top three frequently applied assessment scales in stroke trials. Also, their validity, reliability, responsiveness, and feasibility are described. Furthermore, analytical methods used to assess those functional assessments are highly heterogenous, while dichotomy of scale score is the most widely used. Although there is no consensus on designation of the functional assessment time, three-month is the most popular, reliable, and feasible choice in stroke trails.
Approximately 70 million people worldwide suffer from epilepsy, with about 9 million in China. About one-third of patients demonstrating resistance to traditional antiseizure medications (ASMs), Focal Cortical Stimulation (FCS) emerges as a novel neuromodulation therapy based on neural stimulation, showing potential in treating drug-resistant focal epilepsy. FCS reduces seizure frequency by diminishing abnormal excitability in cortical areas. Compared to traditional surgery, it carries lower risks and is particularly suited for patients whose epileptogenic foci are difficult to surgically localize. Its adjustability provides physicians with treatment flexibility, allowing them to tailor therapy based on patient conditions. Recent studies highlight the practical clinical application of FCS, underscoring its advantages in reducing the frequency of drug-resistant epilepsy seizures. The article concludes by exploring the future prospects of FCS, emphasizing the need for research in long-term efficacy assessment and patient adaptability, thus demonstrating its significant potential and direction for development in the field of epilepsy treatment.