A team with strong cohesion and high execution is an important guarantee for conducting high-quality and sustainable clinical researches. Combined with the previous literature and the author’s view, this paper summarizes the key points of team building, which include a clear research direction, a balanced composition of team members, an outstanding team leader, the competence enhancement of team members, and a member-oriented management philosophy. Clear research direction is the premise of the existence and development of a team. Multi-level, multi-disciplinary membership can avoid potential conflicts of interest caused by homogeneity, and enable research to be refined and strengthened in interdisciplinary collisions. Team leader is the key to team development. The enhancement of team members’ competence is the cornerstone of team development. Adherence to member-oriented principle can form a true team culture. This paper aims to summarize and analyze the key points of clinical research team construction for peer reference.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
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.
Mixed methods research (MMR) is the third research paradigm that combines quantitative and qualitative research. MMR can overcome limitations of qualitative and quantitative methods by integrating the advantages of these two. The environment of real world research is complicated. When using real world data to assess the health status of patients, process of treatment, outcomes of prevention and treatment, prognosis and prediction, and support for medical policy development, MMR can be applied to tackle research questions more comprehensively for the quality of research.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
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.
Objective With reference to the method of operationalization of concept in the field of sociology, this study developed a methodological framework for intervention trials of Chinese medicine (CM) under the mode of syndrome dominating disease. Methods First, an operational definition of the syndrome dominating disease research model was clarified to provide the scope and direction of the methodological framework construction. Then a scoping review was conducted to identify the design features of clinical researches under the model to summarize the basic structure and content of the framework; furthermore, in-depth interviews were carried out to collect the views and suggestions of CM experts on this type of study, which added details to the framework. Finally, a survey was conducted to evaluate the rationality and feasibility of the methodological framework. Results A total of 74 studies were included and 12 CM experts were interviewed, and the results of the literature and interview study were synthesized to form a preliminary methodological framework. Thirty-two experts participated in the survey and most of them held a positive assessment of the rationality of the framework, then according to the experts’ suggestions, the final methodological framework which was a four-level structure with 25 items was established. Conclusion Following the internationally recognized methods and steps, this study develops a rational and feasible methodological framework for CM trials under the mode of syndrome dominating disease, which can provide references for future studies’ design, implementation and evaluation.
