Clinical trial, an important research method, plays a crucial role in the development of medicine. It provides important decision support for medical workers. Medical research proposal should be posted at clinical trial registries. Researchers should update original data and research results, which contributes to data sharing. Clinical trial registration can avoid repetitive research and make clinical trials more transparent and standardized. This paper briefly introduces the clinical trial registration, including the definition, the significance, the history, the scope of registration, the organization of registration, and some common problems in the process of registration. Taking the application of clinical trial registration in the field of neurological research as an example, the article describes the current application status of clinical trial registration and explores it’s value and deficiency in specific clinical research, to provoke the awareness on trial registration, which can help to improve the quality of clinical trials.
Objective To summarize the methods and experience of animal experiment ethics training at home and abroad, analyze the opportunities and problems, and explore the ethics training methods suitable for the current situation of animal experiments in China. Methods Documents relating to animal experiment ethics training from January 2012 to February 2022 were searched in PubMed, Embase, China National Knowledge Infrastructure and Wanfang Data databases. After literature screening and data extraction by 2 researchers independently, descriptive analysis was performed. Results A total of 44 documents were selected, including 19 in Chinese and 25 in English, involving 44 institutions. According to the literature analysis, in the United States, Britain and other developed countries, the welfare and ethical laws for laboratory animals were relatively perfect, such as the Animal Welfare Act of the United States, the Animals (Scientific Procedures) Act of Britain, the Animal Welfare Act of German, and the Act on Welfare and Management of Animals of Japan, while in China administrative regulations were the main ones, and most of the institutions were restricted by management regulations; the ethics of personnel involved in animal experiments were uneven; the training time of some domestic institutions was less than that of institutions abroad; domestic training methods and contents needed to be improved. Basing on the comparative results at home and abroad and combining the training experience, West China Hospital of Sichuan University improved the animal experiment ethics training system. Conclusion It is suggested that the animal experimental institutions in China should improve the training methods, to enhance the awareness and cognition of people involved in animal experiments more systematically and scientifically, and strengthen the ethical review.
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.