中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
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.
The coronavirus disease 2019 (COVID-19) has been evaluated as a pandemic by the World Health Organization (WHO). Although several vaccines with an efficacy of more than 50% have been developed, in terms of treatment, remdesivir remains the antiviral drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, while none of the other treatments has been recommended by FDA due to insufficient clinical data. A number of clinical trials have been registered to study therapeutic drugs or vaccines for COVID-19. To promote the collection, tabulation, analysis of COVID-19 clinical research data, improve the efficiency of clinical research, and facilitate the integration, sharing and secondary analysis of multiple similar research data, CDISC has developed a therapeutic area user guide for COVID-19 and resources for public health researchers. The resources included two documents, one is a SDTM annotated CRF based on ISARIC and WHO core COVID-19 case report form, and the other is SDTM and CDASH mapping spreadsheet. Moreover, CDISC has developed the guidance for ongoing studies disrupted by COVID-19 pandemic and interim ADaM guidance for ongoing studies disrupted by COVID-19 pandemic to help disrupted clinical trials to collect, store, and analyze relevant data. This paper introduced the structure and content of the guide and its related standards, with a view to promoting its application in COVID-19 clinical trials and in ongoing studies disrupted by COVID-19 pandemic.
The scientific research on prevention and control of coronavirus disease 2019 (COVID-19) has been a major and urgent task, of which clinical trials occupy a pivotal position in the entire prevention and control system. 204 relative clinical trials of traditional Chinese medicine (TCM) have been registered on Chinese Clinical Trial Registry. Through the analysis of all online public protocols of registered trials, it is found that the clinical studies of TCM in China showed lack of research foundation, tight time and heavy tasks, difficult clinical implementation, and disturbance by changes of the epidemic status. Based on these characteristics, this paper put forward several thoughts and suggestions on the quality management and design improvement for clinical trials of TCM preventing and treating COVID-19, in order to improve the quality of clinical trials in China, provide effective supports for the public health decision-making on the epidemic, and also give a reference for the prevention and control of epidemics in the future.
The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.
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.
To investigate the shortsegment pedicle screw in treating degenerative L4 spondylolisthesis and the relationship of the preliminarily bending degree of the titanium rod with the lumbar lordosisangle, the slipping angle and the slipping percentage and to evaluate the clinical coincidence and curative effects of the preliminarilybent rod. MethodsFrom September 2005 to March 2007, 31 female patients (age, 40-70 years; average, 58.3 years) were admitted for surgical treatment of their L4 degenerative spondylolisthesis (MeyerdingⅠ°, Ⅱ°)． Their lumbar lordosis angle （x1）, slipping angle (x2), and slipping percentage (x3) were measured in the L4,5 segment before operation. During the operation, the titanium rod bent beforehand according to the corresponding standards was inserted. The angle of the bent rod (Y) was measured, and then the multiple linear regression equation was established. The regression equation was applied to the surgical treatment of the 30 patients.Results According to the criteria in the JOA scoring system, the 31 patients had scores of 8.300± 1.080 and 26.916±1.859 before operation and after operation, respectively. There was a significant difference between before operation and after operation（Plt;0.05）. The established multiple linear regression equation was as follows:Y=0.1390-0.327logx1+0.463x2+0.288x32．The operating time was 51.290±3.408 min in the 30 patients who underwent an insertion of the preliminarilybent rod during the operation; however, the operating time was 102.360±5.004 min in the 31 patients who underwent an insertion of the bent rod that was made based on experience during the previous operations. There was a significant difference in the operating time between the two kinds of the rods （Plt;0.05）. Estimated according to 90%, 95% and 99% of the areas under the normalcurve, the clinical coincidence rates in the preliminarily bending degrees of the titanium rod in the 30 patients were 80.00％，90.00％ and 96.67％, respectively.Conclusion The titanium rod that has been bent into a certain angle before operation according to the established criteria can definitely diminish its strain during operation and efficiently shorten the operating time．Thiskind of the titanium rod has a good coincidence in clinical application and can be effectively used in clinical practice.It is worth reference during the clinical operation.
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.
Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.