New approaches to the assessment and classification of patient's selection parameters for phase II-III clinical trials

Abstract

Objective: to study the rate of enrollment of patients for inclusion in clinical trial according to various parameters and its change under the influence of internal factors, to develop new parameters and indicators that could be sensitive for assessing the effect of the this factors.Materials and methods: a retrospective analysis of phase II-III data from four phase II-III clinical trials in the field of oncology and hematology conducted from 2007 to 2017.Results: the rate of recruitment of patients, other parameters of recruitment of patients and their derivatives, which were influenced by internal factors, were studied.Conclusions: Patient recruitment is affected by internal factors. This impact can be multidirectional: can increase the number of patients or, conversely, reduce it. Knowing the direction of the influence of a certain factor, it is possible to predict the success of both the recruitment of patients and the success of the clinical trial in general.