A novel standard to evaluate the impact of therapeutic agents on patient safety – The BURDEN OF THERAPY™©∗
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 utilize...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2016-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865416300400 |