Çoklu Sonlanım Noktalarına Sahip Klinik Denemelerde Denetleyici Test Stratejileri

July 2013
Turkiye Klinikleri Journal of Biostatistics;2013, Vol. 5 Issue 2, p69
Academic Journal
In this review, the theory and purpose of gatekeeping test strategies for the validity of test results in the clinical trials with multiple endpoints are discussed. In the clinical trials with multiple endpoints, control of Type I error is the main problem in statistical analysis of experiment results. In the clinical trials, the hypothesis for primary endpoints associated with main purpose of the study are related with the effectiveness of the drug or treatment is tested before. In addition to primary endpoints, secondary endpoints are frequently used and the hypothesis are grouped into families according to the importance of endpoint tested. The gatekeeping test strategies are used to analyse this type of hypothesis families. A family is termed a serial gatekeeper if one must reject all primary hypothesis to test secondary hypothesis. If rejecting at least one primary hypothesis is sufficient to test secondary hypothesis, the family is called as paralel gatekeeper. Although gatekkeping strategies generally includes Bonferroni-based procedures, there are more robust methods to correlation structure between endpoints. They are preferred especially in multiple dose and multiple endpoints. In dose-response studies with multiple endpoints, a Dunnett-based parallel gatekeeping test strategy was developed to compare multiple dose-to-control. The number of families, the number of endpoints and the correlation structure between them and selection of test procedures are significant subjects while using gatekeeping test strategies.


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