临床研究杂志

Managing Selection of Sites to Centralized Trials on Stage of Feasibility Based on Calculated Proposed Recruitment

Abstract

Svyatoslav Milovanov

Introduction: Sites where clinical trial will be conducted is the main place in centralized trials in generation data by the patients. Sites without patients lead to absence of clinical trial data and failed of clinical trial. Feasibility stage in selection of sites for conducting of particular clinical trial is emphasis to presence of needed pool of patients. Recruitment of patients in centralized trials is announcing by PI of clinical sites during the feasibility stage. This is subjective decision of investigator based on integral approach like experience, incidence of disease and many other parameters. The objective approach like calculation is apparently needed for calculation of proposed recruitment on the stage of feasibility.

Materials and methods: Retrospective analysis data of four clinical trials II-III phases, conducted since 2007 to 2017 years.

Aim: To find out the approach for selecting the trial sites on predictive basis using objective methods on the on the stage of feasibility.

Statistical analysis: Data had been collected from feasibility questionnaires, open statistical sources.

Results: It was proposed the formula for evaluation of clinical trial site in perspective of recruitment.

Discussion: Selection of sites might be calculated which will decrease the number of failed clinical trials. We called the calculation “Calculated Proposed Patient’s Recruitment”-CPPR».