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Transforming Real-world evidence with Unstructured and Structured data to advance Tailored therapy (TRUST)

Award Number: U01FD007172
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Transforming Real-world evidence with Unstructured and Structured data to advance Tailored therapy (TRUST) - Project Summary There is a national desire to implement real-world evidence (RWE) within regulatory and clinical pathways as a step toward personalized medicine, improved care, and more efficient care. This will accelerate use of routinely collected data to refine care pathways. By influencing what is approved, reimbursed, and selected for care, RWE will adjust the standard of care. But, adjusting the standard of care can have unintended and dangerous consequences. Bad data allowed into a patient’s electronic health record (EHR) has the potential to hurt one patient. Bad data allowed into regulatory or reimbursement pathways can harm a nation. RWE is often used to support trial recruitment, trial design, and marketing insight. As it is increasingly used to make clinical assertions, there is reason to believe that current approaches may benefit from greater rigor. Claims data often have accuracy below 50%. EHR problem lists often have accuracy below 60%. It is believed that low sensitivity incorporates skew since sicker patients with more touch points in the health system have more complete documentation. This program seeks to study data quality in the context of a potential drug launch. Leaders in the space intend to study data quality while testing a novel and highly rigorous approach to RWE. To achieve the goal of understanding how data quality influences RWE assertions, the proposed project includes innovations in phenotyping, gold standard, accuracy measurement, and enhanced privacy and security. This effort comes at a critical time, as regulators, payers, and providers are increasingly incorporating RWE insights into their decision-making processes. By studying data quality and demonstrating safe approaches to RWE, the country can move forward on solid footing.


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 = $0 )
2025	2022	VERANTOS INC	325 SHARON PARK DR	MENLO PARK	CA	94025	SAN MATEO	USA	Food and Drug Administration Research	000	3	2/12/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,895,400 )
2022	2022	VERANTOS, INC.	325 SHARON PARK DR # 730	MENLO PARK	CA	94025	SAN MATEO	USA	Food and Drug Administration Research	000	3	8/23/2022	NON-COMPETING CONTINUATION	$1,895,400
														Subtotal = $1,895,400

Issue Date FY: 2021 ( Subtotal = $1,895,400 )
2021	2021	VERANTOS, INC.	325 SHARON PARK DR # 730	MENLO PARK	CA	94025	SAN MATEO	USA	Food and Drug Administration Research	000	2	7/14/2021	NON-COMPETING CONTINUATION	$1,895,400
2021	2021	VERANTOS, INC.	325 SHARON PARK DR # 730	MENLO PARK	CA	94025	SAN MATEO	USA	Food and Drug Administration Research	001	2	7/20/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,895,400

Issue Date FY: 2020 ( Subtotal = $1,895,400 )
2020	2020	VERANTOS, INC.	325 SHARON PARK DR # 730	MENLO PARK	CA	94025	SAN MATEO	USA	Food and Drug Administration Research	000	1	9/8/2020	NEW	$1,895,400
														Subtotal = $1,895,400

Grand Total All Awards = $5,686,200

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Transforming Real-world evidence with Unstructured and Structured data to advance Tailored therapy (TRUST)

Award Number: U01FD007172

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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