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

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What is the expected benefit of patient-centric clinical development in oncology? / Serra, Alessandra; Mozgunov, Pavel; Jaki, Thomas et al.

In: Journal of Biopharmaceutical Statistics, Vol. 32, No. 3, 31.07.2022, p. 414-426.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

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Serra, A, Mozgunov, P, Jaki, T & Rigat, F 2022, 'What is the expected benefit of patient-centric clinical development in oncology?', Journal of Biopharmaceutical Statistics, vol. 32, no. 3, pp. 414-426. https://doi.org/10.1080/10543406.2022.2065506

APA

Vancouver

Serra A, Mozgunov P, Jaki T, Rigat F. What is the expected benefit of patient-centric clinical development in oncology? Journal of Biopharmaceutical Statistics. 2022 Jul 31;32(3):414-426. Epub 2022 Jul 18. doi: 10.1080/10543406.2022.2065506

Author

Serra, Alessandra ; Mozgunov, Pavel ; Jaki, Thomas et al. / What is the expected benefit of patient-centric clinical development in oncology?. In: Journal of Biopharmaceutical Statistics. 2022 ; Vol. 32, No. 3. pp. 414-426.

Bibtex

@article{446882035b73478582aa342c944363f9,
title = "What is the expected benefit of patient-centric clinical development in oncology?",
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.",
keywords = "Biomarker, drug development, precision oncology, sequence of trials",
author = "Alessandra Serra and Pavel Mozgunov and Thomas Jaki and Fabio Rigat",
year = "2022",
month = jul,
day = "31",
doi = "10.1080/10543406.2022.2065506",
language = "English",
volume = "32",
pages = "414--426",
journal = "Journal of Biopharmaceutical Statistics",
issn = "1054-3406",
publisher = "Taylor and Francis Ltd.",
number = "3",

}

RIS

TY - JOUR

T1 - What is the expected benefit of patient-centric clinical development in oncology?

AU - Serra, Alessandra

AU - Mozgunov, Pavel

AU - Jaki, Thomas

AU - Rigat, Fabio

PY - 2022/7/31

Y1 - 2022/7/31

N2 - 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.

AB - 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.

KW - Biomarker

KW - drug development

KW - precision oncology

KW - sequence of trials

U2 - 10.1080/10543406.2022.2065506

DO - 10.1080/10543406.2022.2065506

M3 - Journal article

VL - 32

SP - 414

EP - 426

JO - Journal of Biopharmaceutical Statistics

JF - Journal of Biopharmaceutical Statistics

SN - 1054-3406

IS - 3

ER -