Automatically compiled and consistent data reports
The pharmacometric team prepared the data reports for the DSMB to review the safety and efficacy of the ongoing trial. Because of the time-sensitive nature of the vaccination trial, initially biweekly reporting was proposed, which was later amended to a lower frequency by request of the DSMB and the clinical team because of reduced clinical urgency. Two types of reports were prepared. The open report showed the data aggregated which was open to review for the whole clinical trial, while the closed report showed the blinded data per study arm for the closed session of the DSMB. The pharmacometric processing script was developed to automatically generate a report based on the integrated database, to prevent repetitive manual report drafting with the suggested frequency. Using this method, a transparent and reproducible workflow was established from the raw eCRF input through to the DSMB report. RMarkdown was used to integrate the R-based processing of the integrated database with Markdown and LaTeX text compilers to create a report in pdf format in which the numerical, graphical, and tabular elements were automatically updated with each compilation (Fig. RMarkdown was used to combine text and R variables in the automatically generated report. (To create the two versions of the report in a consistent manner, an R-variable was integrated into the relevant numerical, graphical, and tabular elements where aggregated or per-arm data was reported. This had the advantage of not having to work in two RMarkdown scripts at the same time with the risk of inconsistencies and code conflicts that occur when coding even when working as diligently as possible. As a result, the open and closed reports showed the exact same data with the only difference being the presentation of these data. The switch-variable (CLOSED) was used in if-statements throughout the report to show figures and tables either aggregated or per arm (Fig. When the DSMB meeting schedule was set, a corresponding data transfer schedule was set. On average, the DSMB received the compiled and reviewed report within 3 days after the cut-off date of the data, including the final unblinded report. The DSMB repeatedly expressed their appreciation for these “excellent turnaround times.”