Dobrova V. Scientific rationale for the methodology of planning and assessment of pre-clinical and clinical trials of medicines.

Approaches to introducing comprehensive methodology for medicine research and GLP, GCP implementation have been first rationalized and developed. The conceptual framework of clinical trials planning as well as a series of mathematical models for assessing such basic parameters as medicine tolerability and efficiency have been suggested. Scientific methodology of planning, organizing and assessing results of clinical trials has been rationalized, whereas complex statistical assessment methods with regard to medicine tolerability in terms of clinical trials, bioequivalence study and efficiency of medicines have been developed. Validation of the suggested methods in terms of pragmatic trials has been carried out. The methodological framework for implementing clinical trial data management system was first developed, personnel interaction models have been suggested, whereas requirements to the on-site trial data management as well as approaches to ensuring proper processing thereof have been rationalized. Motivational factors of voluntary participation in clinical trials have been studied. Motivation system for participation in clinical trials by patients and healthy volunteers has been rationalized, whereas methods of calculating monetary compensation for such participation have been suggested.