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What is the expected benefit of patient-centric clinical development in oncology?
Serra, Alessandra, Mozgunov, Pavel, Jaki, Thomas
und Rigat, Fabio
(2022)
What is the expected benefit of patient-centric clinical development in oncology?
Journal of Biopharmaceutical Statistics 32 (3), S. 414-426.
Veröffentlichungsdatum dieses Volltextes: 29 Sep 2025 11:38
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.77853
Zusammenfassung
The identification and quantification of predictive biomarkers characterize personalized medicine approaches and patient-centric clinical development. In practice, the sponsor needs evaluating whether biomarker-informed clinical development strategies are more likely to benefit current and future patients. To this end, a simple metric is proposed and assessed here quantifying the expected ...
The identification and quantification of predictive biomarkers characterize personalized medicine approaches and patient-centric clinical development. In practice, the sponsor needs evaluating whether biomarker-informed clinical development strategies are more likely to benefit current and future patients. To this end, a simple metric is proposed and assessed here quantifying the expected clinical benefit (ECB) of clinical development programmes. Using simulation scenarios and endpoints relevant to oncology, the ECB of a simple biomarker-informed strategy is shown to be specific and sensitive. Also, the ECB difference is shown to increase in the biomarker-driven incremental efficacy and with the population prevalence of biomarker-positive study participants.
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Details
| Dokumentenart | Artikel | ||||
| Titel eines Journals oder einer Zeitschrift | Journal of Biopharmaceutical Statistics | ||||
| Verlag: | Taylor & Francis Online | ||||
|---|---|---|---|---|---|
| Band: | 32 | ||||
| Nummer des Zeitschriftenheftes oder des Kapitels: | 3 | ||||
| Seitenbereich: | S. 414-426 | ||||
| Datum | 18 Juli 2022 | ||||
| Institutionen | Informatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki) | ||||
| Identifikationsnummer |
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| Stichwörter / Keywords | Biomarker, drug development, precision oncology, sequence of trials | ||||
| Dewey-Dezimal-Klassifikation | 000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik | ||||
| Status | Veröffentlicht | ||||
| Begutachtet | Ja, diese Version wurde begutachtet | ||||
| An der Universität Regensburg entstanden | Zum Teil | ||||
| URN der UB Regensburg | urn:nbn:de:bvb:355-epub-778538 | ||||
| Dokumenten-ID | 77853 |
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