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  1. Oncology Center of Excellence

OCE-Funded Active Extramural Research Projects

The FDA Oncology Center of Excellence is funding the active extramural research projects listed in the table below. Click on the links in the Title column to jump to a brief, plain-language abstract for each project. The table will be updated with additional abstracts as they become available.

OCE uses the following funding mechanisms:

  • The BAA program is an FDA-wide funding mechanism that solicits research proposals from external institutions on an annual basis (see FY2023 announcement). FDA experts review BAA proposals in two stages for scientific and technical merit, program relevance, offeror capability and budget. BAA research contracts are awarded for a maximum of 5 years. Investigators should develop budgets suitable to complete the proposed work, but OCE prefers to fund focused pilot projects. Applications are reviewed on a rolling basis.
  • The CERSI program consists of cooperative agreements with certain institutions selected through a competitive process. Currently, these institutions are Johns Hopkins, University of Maryland, UCSF-Stanford, Yale–Mayo Clinic, and the University of North Carolina. FDA staff may propose projects with investigators at these universities.
Funding Mechanism FY Primary Scientific Research Area Organization Project Title
BAA 2022 Real World Data and Health Equity University of Oklahoma Health Sciences Center - Stephenson Cancer Center Analyzing clinical outcomes and genomic data of American Indian patient population treated with immune checkpoint inhibitors for various cancers
BAA 2022 Real World Data Brigham and Women’s Hospital, Harvard Medical School Calibrating RWE studies in oncology against randomized trials
BAA 2022 Real World Data Alliance NCTN Real World Collection of Radiographic Images and Treatment Emergent Adverse Event Data: Next Phase Development of ICAREdata Research Infrastructure
CERSI 2022 Health Equity Yale University A positive deviance approach for representing women, older adults and patients identifying as racial and ethnic minorities in oncology research
CERSI 2022 Immuno-oncology and Precision Oncology University of California San Francisco Whole exome sequencing to determine risk of immune related adverse events and predict treatment response in patients on immune checkpoint inhibitors
CERSI 2022 Patient Focused Drug Development Mayo Clinic Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients
CERSI 2022 Patient Focused Drug Development Mayo Clinic Longitudinal analysis & visualization of patient-reported physical function & symptom data 
CERSI 2022 Oncology Safety and Health Equity Stanford University Role of Genomic Ancestry in Chemotherapy-Induced Cardiotoxicity Vaccine in Non-Muscle Invasive Bladder Cancer
CERSI 2022 Precision Oncology University of Maryland Precision Medicine Utilizing Bacillus Calmette-Guérin Vaccine in Non-Muscle Invasive Bladder Cancer
CERSI 2022 Precision Oncology Johns Hopkins University  Development of a precision oncology decision support platform to enhance genotype-driven clinical trial recruitment and decentralized personalized medicine approaches
CERSI 2022 Precision Oncology Johns Hopkins University  Non-invasive Integrative Liquid Biopsy Approaches for Precision Immuno-oncology
CERSI 2022 Real World Data and Precision Oncology Yale University  Real-world outcomes of novel PET imaging tracers for prostate cancer
BAA 2021 Real World Data Cardinal Health Development of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies
BAA 2021 Pediatric Oncology Children's Hospital of Philadelphia Pediatric High-Risk Cancer Preclinical Model Resource
BAA 2021 Patient Focused Drug Development Northwestern University Evaluation of a Global Item for Side Effect Bother
BAA 2021 Trial designs, endpoints and statistical methodologies Medical College of Wisconsin Commensurate prior models accommodating historical controls for clinical trials with matched and/or interval-censored data
BAA 2021 Pediatric Oncology St. Jude Modeling Pediatric Solid Tumors and the Tumor Microenvironment
CERSI 2021 Real World Data University of Maryland Building Capacity for Research on Cancer and Aging: The UMGCCC-Medicare Database
CERSI 2021 Precision Oncology University of Maryland An integromic signature for distinguishing malignant from benign growths detected on screening CT scans
BAA 2020 Patient Focused Drug Development Duke University Evaluating Physical Functioning Using Patient-Reported Outcome Measures: How does the question form and recall period influence patients’ interpretation?
CERSI 2020 Patient Focused Drug Development Mayo Clinic Quantifying physical function in cancer patients undergoing chemotherapy using clinician-reported, patient-reported, and wearable device data sources
CERSI 2020 Trial designs, endpoints and statistical methodologies Mayo Clinic Bayesian adaptive basket trial designs for neoantigen based immunotherapy with borrowing strength across subpopulations within the trial and from external controls

 

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