The stepped-wedge design is a research design that implements intervention measures in stages,often used to evaluate the"benefits outweigh the harms"policy intervention effects at the population level.The main feature of this design is that it does not require a separate control group,and it maintains the advantages of the traditional randomized controlled trials even when resources are limited and interventions can only be implemented in stages.Recently,the stepped-wedge design has been increasingly applied in the evaluation of clinical efficacy and the evaluation of protective effects after market approval,such as influenza vaccines,human papillomavirus vaccines(HPV),hepatitis B virus vaccines(HBV),and Ebola vaccines.In this review,the basic principles,applicability,,design types,design elements,application example of the stepped-design in vaccine evaluation were introduced,aiming to provide a reference for future implementation of vaccine clinical research using the stepped wedge design in China.
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维普
