Publications by authors named "H Kulmann"
elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials.
Ther Innov Regul Sci
November 2021
Article Synopsis
- Clinical trials typically present lab data in extensive tables and listings, making review a slow and tedious process for health authority submissions.
- To improve efficiency in exploring lab data, the 'elaborator' app was developed—a user-friendly, interactive browser-based tool that analyzes different types of lab data.
- The app helps study teams identify safety signals and generate hypotheses, requiring some familiarity with R but no programming experience to use effectively.
Background: The analysis of subgroups in clinical trials is essential to assess differences in treatment effects for distinct patient clusters, that is, to detect patients with greater treatment benefit or patients where the treatment seems to be ineffective.
Methods: The software application subscreen (R package) has been developed to analyze the population of clinical trials in minute detail. The aim was to efficiently calculate point estimates (eg, hazard ratios) for multiple subgroups to identify groups that potentially differ from the overall trial result.