| Autor: |
Colleen, Russell, Marie, McCarthy, Joseph C, Cappelleri, Susan, Wong |
| Rok vydání: |
2019 |
| Předmět: |
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| Zdroj: |
Therapeutic innovationregulatory science. 55(1) |
| ISSN: |
2168-4804 |
| Popis: |
The DIA Study Endpoints Community Working Group on Mobile Sensor Technology (MST) series addresses considerations that may be useful for selecting MST for use in a clinical trial. This article describes considerations regarding the selection of MST for clinical trials including expectations around technology specifications, verification (bench testing), regulatory clearance and certification status. We identify useful statistical methods needed to establish agreement of the MST with respect to a clinical 'gold' standard technology in terms of accuracy and precision, and to combine data across trials, data types or device versions. In addition to describing key considerations, this manuscript also serves as a central location citing those resources where additional detail can be found. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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