Abstract: Objective To conduct a comprehensive search on studies regarding master protocols design at home and abroad, to understand the research fields in clinical application, and to provide reference for the implementation and promotion of the research about master protocol design by domestic nursing staff. Methods The scoping review proposed by Arksey and O'Malley was used, and we systematically searched literature in databases of CNKI, Wanfang Database, China Biomedical Literature Database, VIP Database, PubMed, Cochrane Library, Embase,and Web of science from the inception to April 2023. According to the inclusion and exclusion criteria, two researchers independently extracted the core elements of master protocol design and its application, and descriptive analysis and thematic analysis were used to sort out the data. Results A total of 104 pieces of literature were collected, covering oncology, psychology, traditional Chinese medicine, neurology, COVID-19 and drug development evaluation. There were significant differences in the application of master protocols between China and foreign countries, which can be mainly reflected in three aspects. 1) Different application scopes. In foreign countries master protocols were mainly used to evaluate the effectiveness and safety of new drugs, therapies or medical equipment, while in China it was widely applied to traditional Chinese medicine. 2) Different types of research. Multi-center randomized controlled trials and cohort studies were commonly used in foreign countries, while there was relatively less such research in China; 3) Differences in experience and technical support. Richer experience and technical support in the design and implementation of master protocols due to historical and cultural background were observed in foreign countries. Therefore, when promoting and applying master protocols, it was necessary to fully consider the differences between China and foreign countries, and explore suitable research models and methods that fit the local conditions, so as to promote the wider and deeper application. Conclusion The implementation of the master protocols is a breakthrough innovation of the clinical research. At present, the application of master protocols is mainly concentrated in the field of oncology and COVID-19, but the umbrella trial and basket trial can be used in the health field, and the platform trial can be applied to clinical psychology and digital mental health intervention. Domestic nursing researchers should pay attention to the application of master protocols and carry out researches under its guidance to optimize the trial design to adapt to the development of precision medicine.

Key words: master protocol, basket trial, umbrella trial, platform trial, precision medicine, scoping review