Clinical center type in predicting patient enrollment

Background. According to the literature, the final decision for the selection of clinical centers is made on the basis of subjective assessments – personal judgment and assumptions of the working team, which, as a rule, is associated to the lack of objective criteria for assessing a clinical center. The clinical site is responsible for both patient recruitment, in accordance with all protocol criteria and regulatory requirements, and for completing the patient recruitment agreed upon during the patient search phase providing successful achievement of targeted patient recruitment. One of the important conditions for successful patient recruitment is the high-quality selection of clinical centers at the feasibility stage, which requires objective tools to select clinical centers that will recruit patients in accordance with all protocol requirements and achieve the target goals of the clinical trial.

Objective. Searching for objective criteria for evaluating clinical centers providing targeted recruitment of patients.

Methods. Data obtained from 70 clinical centers located in 59 cities of Russia, Belarus and Ukraine (RUB region) generated in 4 clinical studies involving 622 patients were retrospectively analyzed. All 4 studies were successful in patient recruitment. The following values were calculated using the descriptive statistics method: mean, error of mean, standard deviation and coefficient of variation.

Results. Objective criteria for the selection of clinical centers (parameters and indicators) that make it possible to predict the upcoming enrollment of patients in the clinical center have been identified. Based on the grouping of parameters and indicators, 4 types of clinical centers were identified: type 1 – silent, type 2 – low-recruiting, type 3 – medium-recruiting and type 4 – high-recruiting, statistically significantly different in objective parameters of primary response time in days: 31.19±5 .27, 21.43±3.26, 23.64±4.04, 12.7±0.79, respectively, and according to objective indicators “Ratio of Primary Response Time in days/Estimated Patient Enrollment”: 4.56±1, 03, 2.42±0.43, 1.94±0.3, 1.345±0.099, respectively.

Conclusion. For the first time, objective criteria (parameters and indicators) for the selection of clinical centers have been proposed, allowing an objective assessment of the upcoming recruitment at the selected site. For the first time, types of clinical centers have been proposed based on selected objective criteria.