The paper presents the concept of scientific analysis of clinical trials, in which two systems of indexes: the factors of influence and feedback trials have been created, as well as their classification has been performed. The general linear mathematical model of planning of clinical trials and evaluation of its baseline indexes have been substantiated. For assessment of the impact of new drugs for various designs of clinical trials the models of analysis of the impact of medical factors within the group and between groups of patients have been developed. Further clinical verification and interpretation of these models allow to predict the at results of possible drug effects on different groups of indicators of the patients’ state the beginning of the test and prevent the occurrence of inaccurate estimates of the clinical trials.
Key words: clinical trials, linear model, health assessment, factor of influence, feedback index