RESUMO
Continuous medical and safety monitoring of subject data during a clinical trial is a critical part of evaluating the safety of trial participants and as such is governed by protocol procedures and regulatory guidelines to meet the trial's intended objectives. We present an open-source validated graphical tool (clinDataReview R package) which provides access to the trial data with drill-down to individual patient profiles. The tool incorporates functionalities that facilitate detection of error and data inconsistencies requiring follow-up. It supports regular medical monitoring and oversight as well as safety monitoring committees with interactive tables and listings alongside graphical visualizations of the primary safety data in reports. An implementation example is given where the tool is used to deliver validated outputs following FDA/EMA guidelines. As such, this tool enables a more efficient, interactive, and reproducible review of safety data collected during an ongoing clinical trial.
RESUMO
In this study, we analyzed the validity of the conventional 80% power. The minimal sample size and power needed to guarantee non-overlapping (1-alpha)% confidence intervals for population means were calculated. Several simulations indicate that the minimal power for two means (m = 2) to have non-overlapping CIs is .80, for (1-alpha) set to 95%. The minimal power becomes .86 for 99% CIs and .75 for 90% CIs. When multiple means are considered, the required minimal power increases considerably. This increase is even higher when the population means do not increase monotonically. Therefore, the often adopted criterion of a minimal power equal to .80 is not always adequate. Hence, to guarantee that the limits of the CIs do not overlap, most situations require a direct calculation of the minimum number of observations that should enter in a study.