What is the expected benefit of patient-centric clinical development in oncology?

Serra, Alessandra and Mozgunov, Pavel and Jaki, Thomas and Rigat, Fabio (2022) What is the expected benefit of patient-centric clinical development in oncology? Journal of Biopharmaceutical Statistics, 32 (3). pp. 414-426. ISSN 1054-3406

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Abstract

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.

Item Type:
Journal Article
Journal or Publication Title:
Journal of Biopharmaceutical Statistics
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/2700/2736
Subjects:
ID Code:
174030
Deposited By:
Deposited On:
04 Aug 2022 10:30
Refereed?:
Yes
Published?:
Published
Last Modified:
31 Aug 2022 10:20