Recently, real world studies (RWS) have received increasing attentions. Such studies typically involve patient information, and their results may have potentially significant impact on patient well-being and safety. When reviewing the protocol of real world studies, ethical issues should be carefully considered and assessed. This paper discussed three issues, including the overview of bioethics and its application to classic clinical trials, key features of RWS, and medical ethical considerations on RWS.
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 so as to summarizing 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 studies, which added details to the framework. Lastly, 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 hold a positive assessment of the rationality of the framework, then according to the experts’ suggestions, the final methodological framework which is 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.
In order to improve the understanding of pragmatic randomized controlled trial (pRCT), to promote high-quality implementation of such trials, and to provide technical guidance for researchers to conduct such trials scientifically, the working group of China REal world data and studies ALliance (ChinaREAL) hereby develop a technical guidance. The guidance provides technical specifications of pRCT in terms of the concept and scope of application, planning and study design, conduct, data management and quality control, statistical analysis, and ethical issues. It emphasizes that the trial sites and settings, patient population, interventions, controls, outcomes, follow-ups and other factors should be considered when planning and designing. Meanwhile, the guidance recommends that estimation of sample sizes for different types of trial designs should be based on individual pRCTs, and it also provides suggestions for data management, quality control, principles of statistical analysis, analysis requirements for each type of trial designs, and ethical considerations.