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 compare the balance of simple randomization, stratified blocked randomization and minimization. Methods Monte Carlo technique was employed to simulate the treatment allocation of simple randomization, stratified blocked randomization and minimization respectively, then the balance of treatment allocation in each group and the balance for every prognostic factor were compared. Results The simulation demonstrated that minimization provides the best performance to ensure balance in the number of patients between groups and prognostic factors. Balance in prognostic factors achieved with stratified blocked randomization was similar to that achieved with simple randomization. Conclusion Minimization offers the best balance in the number of patients and prognostic factors between groups.
ObjectivesTo analyze the metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.
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.
Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.
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.
The modern clinical research evaluation systems have increasingly emphasized the evaluation of individual patients' clinical characteristics, diagnosis and treatment plans, and complex intervention measures. Traditional randomized controlled trials evaluate fixed interventions and non-adaptive treatment plans, which cannot meet the needs of evaluating adaptive interventions. This has made researchers more inclined to explore an individualized and adaptive clinical trial design, and sequential multiple assignment randomized trial (SMART) has emerged as needed. This article introduces the principles, key elements, and implementation points of SMART design, further explores the limitations of the mismatch between traditional Chinese medicine clinical trial design and syndrome differentiation treatment, and proposes that SMART design can meet the needs of traditional Chinese medicine clinical trials to inspire researchers in designing their plans.
Based on the conclusion of recent clinical research conducted by foreign countries, there is no statistical difference in outcomes between real and placebo acupuncture. This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture, striving for a new way to test for the placebo effect; a way that is more scientific, more suitable for the current conditions of China, while at the same time capable of being recognized internationally. This paper describes a new acupuncture placebo-controlled method. Under the condition of complete patient trust, we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group. From the actual clinical practice, by randomized controlled trial comparing acupuncture and medicine, using the concept as the double-dummy clinical trail, this paper explores the “double-dummy – non-specific sites – random sampling” method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.
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.