Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.
Clinical practice is very important in clinical pharmacology education. However, there are some deficiencies in this field in China. Clinical trial institutions in China are medical institutions that are qualified to undertake drug clinical trials. There are hardware and software for clinical pharmacology practice, and high-quality teaching personnel with medical, teaching, and scientific research backgrounds in the clinical trial institutions, which can be used as clinical pharmacology teaching practice bases. Therefore, this article discusses the practice of clinical pharmacology teaching reform using clinical trial institutions as a practical platform, and aims to put forward teaching reform ideas that combining students’ clinical pharmacology research practice on the basis of theoretical teaching.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
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.
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.
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.
Dyspnea is the most common symptom in patients with acute heart failure syndrome (AHFS), and relieving dyspnea is an important goal in clinical practice, clinical trials and new drug regulatory approval. However, in clinical and scientific research, there is still no consensus on how to evaluate dyspnea, and there is still a lack of unified measurement methods. This article introduces the pathophysiological mechanism of dyspnea in acute heart failure, the measuring time of dyspnea, the posture of patients during measurement, the measuring conditions, and the common measurement methods of dyspnea in clinical trials and their advantages and disadvantages, so as to provide references for the selection of measurement methods of dyspnea in clinical trials of acute heart failure.
Evidence-based medicine (EBM) is a new technique for medical research. It is interesting to know how to publish a high quality paper after clinical trial by the criteria of EBM. This paper presents our experience on clinical trials as well as publishing EBM papers, including the aim of research, the design of study methods, the selection and application of statistical methods, the analysis of study results, feedback to the reviewer’s comments, and other technology related to the submitted manuscript, in order to improve the skill of publishing EBM study in our country.