A novel standard to evaluate the impact of therapeutic agents on patient safety - The BURDEN OF THERAPY™^©∗.

ABSTRACT:

Purpose

Currently, treatment-emergent adverse events (TEAEs) during a clinical study are summarized over the entire study period.

Objective

Develop and validate a novel methodology, BURDEN OF THERAPY^©∗ (BOTh^©∗), to quantify presence and severity of TEAEs on each day of study.

Methods

BOTh utilizes patient-level safety data to derive a quantitative estimate for the burden of TEAEs that all or individual patients experience on each day of a clinical study. Burden estimate for each day is based on number and severity of TEAEs. A chart displays the total burden experienced by patients on each day throughout the study and statistical analyses may be performed with the area under curve. Methodology was applied to two validated and published clinical st

SUBMITTER: Abdulahad AK 

PROVIDER: S-EPMC5935900 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature