Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis

doi:10.1200/PO.24.00358

Editorial

. 2024 Jul:8:e2400358.

doi: 10.1200/PO.24.00358.

Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis

Hajime Uno^{1

2

3}, Miki Horiguchi^{1

2

4}

Affiliations

¹ Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
² Division of Biostatistics, Department of Data Science, Dana-Farber Cancer Institute, Boston, MA.
³ Department of Medicine, Harvard Medical School, Boston, MA.
⁴ Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA.

PMID: 39038245
PMCID: PMC11268792
DOI: 10.1200/PO.24.00358

Editorial

Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis

Hajime Uno et al. JCO Precis Oncol. 2024 Jul.

. 2024 Jul:8:e2400358.

doi: 10.1200/PO.24.00358.

Authors

Hajime Uno^{1

2

3}, Miki Horiguchi^{1

2

4}

Affiliations

¹ Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
² Division of Biostatistics, Department of Data Science, Dana-Farber Cancer Institute, Boston, MA.
³ Department of Medicine, Harvard Medical School, Boston, MA.
⁴ Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA.

PMID: 39038245
PMCID: PMC11268792
DOI: 10.1200/PO.24.00358

Abstract

Biomarker-driven trials are key for precision oncology but challenge design and analysis.

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Comment on

Biomarker-Driven Oncology Trial Design and Subgroup Characterization: Challenges and Potential Solutions.
Wang J, Yu B, Dou YN, Mascaro J. Wang J, et al. JCO Precis Oncol. 2024 Jun;8:e2400116. doi: 10.1200/PO.24.00116. JCO Precis Oncol. 2024. PMID: 38848518 Review.

References

1. Wang J, Yu B, Dou Y, et al. : Biomarker-Driven Oncology Trial Design and Subgroup Characterization: Challenges and Potential Solutions. JCO Precision Oncology: TBD - PubMed
1. Wasserstein RL, Lazar NA: The ASA Statement on p-Values: Context, Process, and Purpose. The American Statistician, 70(2), 129–133, 2016. 10.1080/00031305.2016.1154108 - DOI
1. Uno H, Horiguchi M, Hassett MJ: Statistical Test/Estimation Methods Used in Contemporary Phase III Cancer Randomized Controlled Trials with Time-to-Event Outcomes. The Oncologist, 25(2), 91–93, 2020. - PMC - PubMed
1. Uno H, Claggett B, Tian L, et al. : Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol 32, 2380–2385, 2014. - PMC - PubMed
1. Horiguchi M, Hassett MJ, Uno H: How do the accrual pattern and follow-up duration affect the hazard ratio estimate when the proportional hazards assumption is violated? The Oncologist, 24(7), 867–871, 2019 - PMC - PubMed

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R01 GM152499/GM/NIGMS NIH HHS/United States

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[1] Wang J, Yu B, Dou Y, et al. : Biomarker-Driven Oncology Trial Design and Subgroup Characterization: Challenges and Potential Solutions. JCO Precision Oncology: TBD - PubMed

[2] Wang J, Yu B, Dou Y, et al. : Biomarker-Driven Oncology Trial Design and Subgroup Characterization: Challenges and Potential Solutions. JCO Precision Oncology: TBD - PubMed

[3] Wasserstein RL, Lazar NA: The ASA Statement on p-Values: Context, Process, and Purpose. The American Statistician, 70(2), 129–133, 2016. 10.1080/00031305.2016.1154108 - DOI

[4] Wasserstein RL, Lazar NA: The ASA Statement on p-Values: Context, Process, and Purpose. The American Statistician, 70(2), 129–133, 2016. 10.1080/00031305.2016.1154108 - DOI

[5] Uno H, Horiguchi M, Hassett MJ: Statistical Test/Estimation Methods Used in Contemporary Phase III Cancer Randomized Controlled Trials with Time-to-Event Outcomes. The Oncologist, 25(2), 91–93, 2020. - PMC - PubMed

[6] Uno H, Horiguchi M, Hassett MJ: Statistical Test/Estimation Methods Used in Contemporary Phase III Cancer Randomized Controlled Trials with Time-to-Event Outcomes. The Oncologist, 25(2), 91–93, 2020. - PMC - PubMed

[7] Uno H, Claggett B, Tian L, et al. : Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol 32, 2380–2385, 2014. - PMC - PubMed

[8] Uno H, Claggett B, Tian L, et al. : Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol 32, 2380–2385, 2014. - PMC - PubMed

[9] Horiguchi M, Hassett MJ, Uno H: How do the accrual pattern and follow-up duration affect the hazard ratio estimate when the proportional hazards assumption is violated? The Oncologist, 24(7), 867–871, 2019 - PMC - PubMed

[10] Horiguchi M, Hassett MJ, Uno H: How do the accrual pattern and follow-up duration affect the hazard ratio estimate when the proportional hazards assumption is violated? The Oncologist, 24(7), 867–871, 2019 - PMC - PubMed

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Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis

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Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis

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