Introduction of multicenter design in the non-clinical phase to overcome translational barriers in clinical trials

Abstract

Background. The translating of individual preclinical studies (PCTs) results into clinical practice is accompanied by a significant number of failures and is associated with significant time and financial costs. The unsatisfactory design of individual non-clinical studies and the reports submitted after having done in vivo experiments at one laboratories do not allow overcoming translational barriers and increasing the results reproducibility. To conduct multicenter non-clinical trials is relevant to to confirm the effectiveness of medicines and increase the chances of successful translation of non-clinical results into clinical practice.Objective. To analyze the scientific literature devoted to multicenter non-clinical studies in the research of the pharmacological activity of new drugs.Design and methods. The research was done using PubMed and Google Scholar databases. The review included available publications as of October 16, 2022.Results. It was discovered that single-center studies did not allow predicting the magnitude of the effect accurately, and large sample sizes made the estimation of the magnitude of the effect even less precise.Conclusions. The main purpose of multicenter non-clinical studies rather should be assessing the direction of the effect, including its “stability”, as well as to identify sources of heterogeneity between studies conducted in different laboratories (centers) than performing a quantitative assessment of the effect on several laboratories, as it tend to be in foreign non-clinical practice.