Local Laboratory Reference Intervals in Clinical Trials
| Autor: | F. Peter Treasure, Jaap H. M. Dijkman, Callum G. Fraser, Gordon F. Kapke |
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| Rok vydání: | 2009 |
| Předmět: | |
| Zdroj: | Drug Information Journal. 43:139-150 |
| ISSN: | 2164-9200 0092-8615 |
| Popis: | Assessment of whether laboratory results in clinical studies are abnormal relies heavily on the laboratory upper or lower reference limits. While central laboratories use a single reference interval for an entire study population, local laboratories apply their own reference intervals. Due to bias caused by method differences between local laboratories, such reference intervals are not interchangeable. We have compared the reference intervals of local laboratories after harmonizing their test results, using an analytical calibration step for routine clinical biochemistry analytes. Our results show that differences in local reference intervals could result in significantly variable criteria being used for assessment of normality versus abnormality—up to more than 30%. Significant differences were observed for most analytes used in routine safety monitoring. We conclude that local reference intervals are not useful for drug toxicity trend analysis. Instead, a single reference interval after data harmonization can be used with advantage in addition to assessment of changes in individuals versus their baseline results. |
| Databáze: | OpenAIRE |
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