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Accelerating biomarker development through novel statistical methods for analyzing phase III/IV studies

Award Number: R01CA277133
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2022
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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Accelerating biomarker development through novel statistical methods for analyzing phase III/IV studies - Project Summary/Abstract The multitude of candidate cancer biomarkers being discovered across various laboratories hold great potential to enhance the practice of precision medicine. However, it is a long and challenging process – often culminating in failure – to rigorously develop and validate these biomarkers before they can be used in clinical practice. In particular, phase III, IV, and V biomarker validation studies are expensive and time- consuming to conduct; it is essential to carefully design and analyze these studies and to make the most efﬁcient use of the specimens collected. Motivated by our collaborative work on biomarker development for cancer early detection, this proposal seeks to develop cutting-edge statistical tools for analyzing phase III and IV biomarker studies in order to accelerate the biomarker development process. The methods proposed in Aim 1 target the selection of primary endpoints and inference procedures to accommodate potential overdiagnosis when assessing screening efﬁcacy in phase IV trials. The methods proposed in Aim 2 enable the combination of phase IV samples with phase III samples in phase III biomarker development. The methods proposed in Aim 3 integrate information from heterogeneous study cohorts (which differ in screening modalities and eligibility criteria) when estimating design parameters for biomarker clinical utility trials. Our statistical methods will have immediate applications to analysis of data from two cancer applica- tions: i) the New Onset Diabetes (NOD) Cohort study and the Early Detection Initiative (EDI) study for pancreatic cancer early detection, and ii) ﬁve low-dose CT (LDCT) screening cohorts and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening (PLCO) trial for lung cancer screening. Moreover, the developed methodology will have broader application in other phase III and IV cancer biomarker studies and will be valuable for advancing the NCI Early Detection Research Network (EDRN)'s current priority in designing biomarker clinical utility trials. All statistical programs and algorithms developed in this proposal will be made freely available to the public.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $361,548 )
2026	2026	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	4	12/10/2025	NON-COMPETING CONTINUATION	$361,548
														Subtotal = $361,548

Issue Date FY: 2025 ( Subtotal = $401,719 )
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	3	11/15/2024	NON-COMPETING CONTINUATION	$361,548
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	3	6/3/2025	NON-COMPETING CONTINUATION	$40,171
														Subtotal = $401,719

Issue Date FY: 2024 ( Subtotal = $381,633 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	2	11/29/2023	NON-COMPETING CONTINUATION	$361,548
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	2	4/15/2024	NON-COMPETING CONTINUATION	$20,085
														Subtotal = $381,633

Issue Date FY: 2023 ( Subtotal = $413,415 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	1	11/15/2022	NEW	$413,415
														Subtotal = $413,415

Grand Total All Awards = $1,558,315

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Accelerating biomarker development through novel statistical methods for analyzing phase III/IV studies

Award Number: R01CA277133

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/01/2022

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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