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.
