Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

Introduction: In multicenter studies, the protocolization of data is a critical phase that can generate biases. The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data-manager. Methods: National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (i) center of origin; and (ii) centralized by a data manager. The concordance between the data is analyzed for the global data and for the two groups of the project: (i) study group (familiar carcinoma, 30 researchers protocolize); (ii) control group (sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. Results: The study includes a total of 689 patients with carcinoma: 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa = 0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa = 0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa = 0.922). Also, 4.6% of transcription errors were detected. Conclusions: In multicenter clinical studies, the centralized data protocolization by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin. (c) 2023 AEC. Published by Elsevier Espana, S.L.U. All rights reserved.

Automated summary

This study aims to analyze the concordance and reliability of data protocolization in multicenter clinical studies. The results show that the centralized data protocolization by a data-manager presents similar results to the direct protocolization in the center of origin.