Dados do Trabalho

Título

A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data

Introdução

The COVID-19 pandemic has highlighted that clinical trials conducted in accordance with good clinical practices are needed to support evidence-based policies with high-quality data while protecting the safety, well-being, and rights of the participants. Monitoring of clinical trials is critical to the protection of human subjects and the conduct of high-quality research. Even though the adoption of risk-based monitoring (RMB) has been recommended by regulatory agencies since 2013 and it is also suggested by the ICH guidelines, the RBM approach has been less widespread than expected. Remote-site monitoring with reduced SDV was a sine qua non condition during the pre-vaccine period of the pandemic. Centralized monitoring consists of remotely assessing the quality of electronic data to identify data discrepancies through automated assessments. Herein we share the code of a centralized monitoring tool alongside CRFs and synchronous automated routines that were developed at the clinical research platform, Fiocruz, for a COVID-19 clinical trial. Centralized monitoring consists of remotely assessing the quality of electronic data to identify data discrepancies through automated assessments. It encompasses data review and analysis performed remotely from the trial site to scrutinize the collected subjects’ data to identify unusual patterns, protocol deviations or missing or invalid data. Electronic data capture systems that are secure and provide audit trails to track data manipulation, such as REDCap, have become a mainstay of RBM and central monitoring.

Objetivo (s)

Describe a tool developed for central monitoring of a COVID-19 clinical trial alongside Case Report Forms and synchronous automated routines using an R script.    

Material e Métodos

These open-science solutions for a COVID-19 clinical trial (RBR-85vh8fx) were developed at the clinical research platform, Fiocruz. The REDCap (version 12.0.28), was used to this trial data management. To implement a centralized monitoring routine, an application was developed using the R (version 4.0.2) statistical software to write the code and the Shiny R package, used to build webpages based on R codes. This application accessed and analysed the project databases in REDCap and is connected to REDCap using an application programming interface (API) token.

Resultados e Conclusão

These open science solutions are a complementary tool to clinical trials’ data management. Together with other initiatives, these powerful tools may help push towards the adoption of centralized monitoring and RBM.

Palavras Chave

Pesquisa Clínica; Código aberto; Software R; COVID-19; Monitoria baseada em risco; Monitoria central; leishmaniose