Keep your trial on track: A data visualization approach to data collection monitoring in clinical trials
Background: Ensuring the quality of data collected in clinical trials can be a challenging task. Additional challenges arise in trials deployed in emergency department settings where factors such as low participant enrollment and loss of follow-up may be more prevalent. In this study, we describe the development of a data quality dashboard platform to provide real-time information on critical aspects of trial management for the trial “A Pragmatic Randomized Adaptive Clinical Trial to Investigate a Culturally Adapted Brief Negotiational Intervention for Alcohol Use in the Emergency Department in Tanzania” (NIH/NIAAA R01AA027512, PI Staton; https://clinicaltrials.gov/ct2/show/NCT04535011) .Methods: We used an open-source solution named Shiny, based on the R programming language to develop a data quality monitoring dashboard to assess key parameters from an adaptive clinical trial. Briefly, the indicators included in the dashboard and the system requirements were defined after a needs assessment process addressing the specifications requested by trial sponsors and regulatory policies. Results: The resulting dashboard (available at: http://rapid-1698.vm.duke.edu:3842/pract/) is capable of providing real-time information on various aspects of trial management, including enrollment trends, record errors and missing data, patient follow-up status, and patient safety. The automated nature of the tool allows trial investigators and staff to inspect the data at a glance, without the need for direct access to sensitive data and coding skills. Overall, the integration of the dashboard into the trial management process increased the efficiency that decisions are made, thus ensuring adherence to regulatory policies and improving the care provided to patients.Conclusions: This work shows that data visualization solutions such as dashboards can aid in the management of clinical trials by addressing complex tasks and improving adherence to protocols and guidelines. However, it is important to note that the findings of this study may not be generalizable to other clinical trials with different designs, protocols, software, or infrastructures.
