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 | University of California San Francisco | Elucidating 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 | Biomarkers for Precision Medicine in Lung Cancer |
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 |