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Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug Tolerability

Award Number: U01CA233046
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/08/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug Tolerability - PROJECT ABSTRACT In cancer clinical trials, it is essential to understand and communicate the negative impact of drugs on patient participants in order to balance risks and benefits. Symptom side effects such as nausea and diarrhea are particularly common and impactful on the patient experience. However, historically this information has been reported by clinicians on behalf of their patients rather than by patients themselves – a process that has been shown to miss up to half of patients' symptoms. Therefore, the National Cancer Institute (NCI) supported development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), a library of questions to enable systematic patient self-reporting of side effect information. To date, the PRO-CTCAE questions have been developed and tested for validity and feasibility of use in clinical trials – work that was led by the investigators on this proposal under contracts to the NCI. However, it is not yet established how best to combine PRO-CTCAE information with traditional measures of treatment impact such as clinician-reported adverse events, time on treatment, drug dose levels, performance status, and hospitalizations. The purpose of this supplement is to complete work towards understanding the role of the PRO-CTCAE in combination with these traditional measures of treatment impact in assessments of drug tolerability. In this supplement, advanced statistical methods will be used to analyze data from newly available clinical trials, delayed by the pandemic, accessible to the team through the National Clinical Trial Network (cooperative groups) and industry. The specific aims are to: 1) characterize relationships between the PRO-CTCAE and traditional measures of treatment impact and tolerability; 2) test and standardize analytic techniques for the PRO-CTCAE; 3) refine approaches to analyzing missing PRO-CTCAE data; and 4) develop and refine tabular and graphical data visualizations for longitudinal PRO-CTCAE data. To accomplish these aims, our multi-disciplinary team will work collaboratively and flexibly with other investigators and stakeholders through the U01 consortium chaired by Dr. Amylou Dueck, and will continue to share data, statistical programming code, and ideas freely. This work is intended to inform best practices for tabulating and reporting PRO-CTCAE data, and will enable more systematic and patient-centered evaluations of tolerability in cancer clinical trials. This supplement will extend the grant by 12 months.


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: 2025 ( Subtotal = -$1,160 )
2025	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	5	12/19/2024	SUPPLEMENT FOR EXPANSION	-$1,160
														Subtotal = -$1,160

Issue Date FY: 2023 ( Subtotal = $269,200 )
2023	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/18/2023	SUPPLEMENT FOR EXPANSION	-$80,798
2023	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	5	8/15/2023	SUPPLEMENT FOR EXPANSION	$349,998
2023	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	002	5	8/31/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	003	5	9/11/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $269,200

Issue Date FY: 2022 ( Subtotal = $554,283 )
2022	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/31/2022	NON-COMPETING CONTINUATION	$554,283
2022	2021	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	4/19/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $554,283

Issue Date FY: 2021 ( Subtotal = $469,493 )
2021	2021	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	8/26/2021	NON-COMPETING CONTINUATION	$469,493
														Subtotal = $469,493

Issue Date FY: 2020 ( Subtotal = $530,934 )
2020	2020	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	3	8/11/2020	NON-COMPETING CONTINUATION	$530,934
2020	2019	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	2/25/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $530,934

Issue Date FY: 2019 ( Subtotal = $537,655 )
2019	2019	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	8/29/2019	NON-COMPETING CONTINUATION	$537,655
														Subtotal = $537,655

Issue Date FY: 2018 ( Subtotal = $595,910 )
2018	2018	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/20/2018	NEW	$595,910
														Subtotal = $595,910

Grand Total All Awards = $2,956,315

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Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug Tolerability

Award Number: U01CA233046

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/08/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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