Ideal recruitment rate in clinical trials in phases II–III

Abstract

Actuality. The speed of patient recruitment into a clinical trial allows us to evaluate the work of the clinical center and calculate the time required to achieve targeted recruitment. The authors estimate the recruitment rate on the basis of comparison with the target recruitment value, and according to the literature, the recruitment rate is influenced by many factors, which mainly have a negative effect, reducing it. Assessments of the optimality of recruitment or the normality of recruitment of patients according to the literature were always made based on a specific protocol and nosology because this parameter cannot be constructed experimentally under ideal conditions in the absence of the influence of one or another factor. On the other hand, most clinical trials fail to recruit patients, and accordingly, the recruitment rate in such studies was strongly influenced by certain factors. For the first time, we assessed the patient recruitment rate in successful studies when calculating the degree of influence of the nosology and found the ideal recruitment rate, i. e., the recruitment rate with zero influence of the factor.Objective. To quantify the degree of influence of the nosology factor of the protocol on the recruitment rate of patients in a clinical trial.Materials and methods. A retrospective analysis of 4 international multicenter clinical trials of II–III phases was conducted on the recruitment of patients depending on the influence of the nosology factor of the protocol. Descriptive statistics using the typing and odds ratio technique.Results and discussion. A quantitative assessment of the influence of the nosology factor of the protocol on the rate of patient recruitment was obtained. Found the ideal typing speed.Conclusions. For the first time, a quantitative assessment of factors influencing patient recruitment has been proposed. For the first time, the ideal recruitment rate has been determined.