ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.