Many clinical studies have failed due to a lack of required per protocol enrollment of participant patients. During the feasibility stage, the PI of clinical sites announces the recruitment of subjects in centralised trials. This is a subjective choice made by the investigator based on a holistic approach that includes factors such as experience, disease occurrence, and a variety of other factors. On the stage of feasibility, an objective approach such as calculation appears to be required for the calculation of suggested recruitment. Materials and Methods: data from four clinical trials II-III stages conducted between 2007 and 2017 were analysed retrospectively. Study Goals: To determine the method for calculating the proposed by sites recruiting on a specific study on the basis of feasibility. Data was acquired from feasibility questionnaires and available statistical sources for statistical analysis. Results: A formula for calculating planned patient recruitment on the feasibility stage was proposed. Discussion: Patient recruitment could be calculated, reducing the number of failed clinical studies. The calculation was dubbed "Calculated proposed recruitment of patients" or "CPRP."
Author(s) Details
Department of Physician, Moscow Москва, Russia.
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