دورية أكاديمية
Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation
| العنوان: | Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
|---|---|
| المؤلفون: | Eichler, Hans-Georg, Koenig, Franz, Arlett, Peter, Enzmann, Harald, Humphreys, Anthony, Pétavy, Frank, Schwarzer-Daum, Brigitte, Sepodes, Bruno, Vamvakas, Spiros, Rasi, Guido |
| المساهمون: | Eichler, H, Koenig, F, Arlett, P, Enzmann, H, Humphreys, A, Pétavy, F, Schwarzer-Daum, B, Sepodes, B, Vamvakas, S, Rasi, G |
| بيانات النشر: | WILEY |
| سنة النشر: | 2020 |
| المجموعة: | Universitá degli Studi di Roma "Tor Vergata": ART - Archivio Istituzionale della Ricerca |
| مصطلحات موضوعية: | Settore MED/07 - MICROBIOLOGIA E MICROBIOLOGIA CLINICA |
| الوصف: | Real-world data and patient-level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make novel analytical methods acceptable for regulators and other decision makers will require their testing and validation in broadly the same way one would evaluate a new drug: prospectively, well-controlled, and according to a pre-agreed plan. From a European regulators' perspective, the established methods qualification advice procedure with active participation of patient groups and other decision makers is an efficient and transparent platform for the development and validation of novel study designs. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/31574163; info:eu-repo/semantics/altIdentifier/wos/WOS:000520945900021; volume:107; issue:4; firstpage:773; lastpage:779; numberofpages:7; journal:CLINICAL PHARMACOLOGY & THERAPEUTICS; https://hdl.handle.net/2108/315379Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85074402829 |
| DOI: | 10.1002/cpt.1638 |
| الإتاحة: | https://doi.org/10.1002/cpt.1638Test https://hdl.handle.net/2108/315379Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.41CE7AA2 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/cpt.1638 |
|---|