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Serra, Alessandra ; Mozgunov, Pavel ; Jaki, Thomas ; Rigat, Fabio

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.



Beteiligte Einrichtungen


Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftJournal of Biopharmaceutical Statistics
Verlag:Taylor & Francis Online
Band:32
Nummer des Zeitschriftenheftes oder des Kapitels:3
Seitenbereich:S. 414-426
Datum18 Juli 2022
InstitutionenInformatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki)
Identifikationsnummer
WertTyp
10.1080/10543406.2022.2065506DOI
Stichwörter / KeywordsBiomarker, drug development, precision oncology, sequence of trials
Dewey-Dezimal-Klassifikation000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenZum Teil
URN der UB Regensburgurn:nbn:de:bvb:355-epub-778538
Dokumenten-ID77853

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