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。
Survival data were widely used in oncology clinical trials. The methods used, such as the log-rank test and Cox regression model, should meet the assumption of proportional hazards. However, the survival data with non-proportional hazard (NPH) are also quite usual, which will decrease the power of these methods and conceal the true treatment effect. Therefore, during the trial design, we need to test the proportional hazard assumption and plan different analysis methods for different testing results. This paper introduces some methods that are widely used for proportional hazard testing, and summarizes the application condition, advantages and disadvantages of analysis methods for non-proportional hazard survival data. When the non-proportional hazard occurs, we need to choose the suitable method case by case and to be cautious in the interpretation of the results.
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.
With the gradual standardization and improvement of the real-world study system, real-world evidence, as a supplement to evidence from classical randomized controlled trials, is increasingly used to evaluate the effectiveness and safety of pharmaceuticals and medical devices. High-quality real-world evidence is not only related to the quality of real-world data, but also depends on the type of study design. Therefore, as one of the important designs for pragmatic clinical trials, the Zelen design has received much attention from investigators in recent years. This paper discussed the implementation processes, subtypes of design, advantages, limitations, statistical concerns, and appropriate application scenarios of the Zelen design, on the basis of published papers, in order to clarify its application value, and to provide references for future research.
Economic evaluation used alongside clinical trials has become a hot spot in the development of clinical studies. The definition and classification of the cost were introduced in this article. The ways to conduct cost analysis in clinical trials were introduced systematically, including the identification, collection and analysis of the data of costs, and the concern of the analysis.
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.
Early and mid-stage esophageal cancer can achieve a particular effect through surgeries or comprehensive treatment based on surgery. Once the esophageal cancer progresses to the advanced stage, it is still lack of effective remedy for the disease, and the patient's prognosis is poor. Immunotherapy has developed rapidly in recent years, bringing dawn to patients with advanced esophageal cancer. On July 31, 2019, the US Food and Drug Administration (FDA) approved KEYTRUDA (Merck) for the treatment of esophageal squamous cell carcinoma, and it became the first milestone drug for esophageal squamous cell carcinoma. In the paper, we will review the progress of immunotherapy in the treatment of advanced esophageal cancer on the basis of current clinical researches, which might provide ideas for further studies in the immunotherapy for esophageal cancer.
Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.
Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second- line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.
Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.