Real-world data to generate real-world evidence in regulatory decision-making

Active Cooperative Agreement Awarded Last action

Award ID
U01FD007943
Recipient
Awarding agency
Obligated
$4,472,227

Award facts

Assistance listing
93.103 Food and Drug Administration Research
Completion date 79% complete
Originally
Funding agency
Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
Place of performance
Philadelphia, PA 19103, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
The rationale for a more detailed understanding of the safety and efficacy of new therapies for cancer is compelling. While cancer therapies have always had an element of risk to both well-being and to quality of life, much has changed in therapeutics in the past ten years. Most important, a greater understanding of the biological characteristics of cancer has led to more nuanced definitions of populations that may benefit than were previously possible. With greater use of genomics and resulting specification of precise molecular characteristics of target cancers, and through (though early) markers of sensitivity and resistance to immunotherapeutics, both the indications and the use of novel therapeutics is resulting in higher response rates and more favorable outcomes, at least as judged by progress in clinical trials. Parallel advances in medical care and the universal adoption of an electronic health record (EHR), coupled with advances in quality of life (QOL) and other patient-reported outcomes (PROS), have made possible a deeper analysis of the effects and the risks of new therapies as their use is diffused throughout the medical system. Following upon several guidances to the effect of encouraging and defining the use of real-world data (RWD) to provide real- world evidence (RWE), this funding mechanism is designed to foster approaches to capture, organize, and analyze RWD to produce RWE. We propose herein a many-pronged approach that brings together two strategies: 1) a reimagining of how acquisition of robust, representative, and accurate RWD could be obtained from existing clinical trials' processes; 2) how an effective RWD approach could generate robust RWE in rare and less common tumors alike. To assist in this goal, we have developed a collaboration with optum life sciences, both to help recruit diverse populations with specific molecular profiles, and to characterize populations with extended databases in various domains. Our aims are first, to harmonize phase III and phase IV evaluations of new therapies to obtain real-world evidence of the standard therapy in phase III, and subsequently of the successful therapy in phase IV; second, using this cooperative group model, to establish feasibility of a real-world data phase IV approach to the evaluation of new therapies for rare tumors. We expect that by developing these approaches to rigorous data collection in a short timeframe, we will be complementary to informatics approaches to data collection developed in parallel and provide for them a robust database for comparative analyses.

Transactions

Action Obligated Date
Amendment $0
Amendment $0
Amendment $0
Amendment $2,247,715
Original award $2,224,512

Subawards

Subrecipient Amount Awarded
Coalition Of Cancer Cooperative Groups YR3 FDA REAL World Funding $347,394
Dana-Farber Cancer Institute, Inc. YR3 RWD Funding $171,852
Northwestern University Real World Data YR3 Funding $45,501
The Trustees Of The University Of Pennsylvania $47,863
The University Of Texas Southwestern Medical Center YR2 Real World Funding $31,526
Northwestern University $108,814
Dana-Farber Cancer Institute, Inc. YR2 RWD Funding $189,000
The Trustees Of The University Of Pennsylvania $73,023
The Trustees Of The University Of Pennsylvania YR1 RWD Funding As ECOG-ACRIN Group Co-Chair, Dr. O’Dwyer shares responsibilities for the overall scientific direction of the Group, for setting… $69,906
The University Of Texas Southwestern Medical Center Under the direction of Dr. Suzanne Cole, The University of Texas Southwestern Medical Center will perform the Project, Real-World Data to Generate Real-World… $83,250
Coalition Of Cancer Cooperative Groups Duncan MacLaren, Senior Counsel, assists the General Counsel and Senior Director of Grants and Contracts with the review and execution of contracts between… $796,142
Northwestern University Al B. Benson III, MD, FACP, FACCC, FASCO, Co-Principal Investigator, along with fellow Co-PIs Peter O’Dwyer, MD, Suzanne Cole, MD, and Xin Victoria Wang,… $84,474
Show all 12

Quick answers

Who received award U01FD007943?

U01FD007943 was awarded to Ecog-Acrin Medical Research Foundation, Inc. by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 1, 2023.

How much is award U01FD007943 worth?

$4,472,227 has been obligated on U01FD007943.

Which agency awarded U01FD007943?

FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD007943, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).

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