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 FY2025 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 |
|---|---|---|---|---|
| CERSI | 2024 | Precision Oncology | Johns Hopkins University | Integrative liquid biopsy approaches to capture minimal residual disease and inform therapeutic decisions for patients with resectable cancers |
| CERSI | 2024 | Precision Oncology | Johns Hopkins University | Detection of circulating tumor DNA in a surgery-sparing approach for patients with mismatch repair deficient colorectal cancer |
| CERSI | 2024 | Trial designs, endpoints, and statistical methodologies | Johns Hopkins University | Navigating immortal time bias: impacts of index date selection and analytic techniques in ECTs |
| CERSI | 2024 | Real World Data | Duke University | Racial and Ethnic Differences in Real-World Clinical Outcomes of IDH1 and IDH2 Inhibitors in Acute Myeloid Leukemia |
| CERSI | 2024 | Real World Data | University of North Carolina | Index date selection for external comparators in assessment of cancer therapies |
| CERSI | 2024 | Real World Data | University of California, San Francisco | Real-world data to improve diversity and inclusion of participants in randomized controlled trials and evidence for post-market safety and effectiveness of targeted therapies in oncology for equitable decision making |
| CERSI | 2024 | Rare Cancers | University of California, San Francisco | Comprehensive surfaceome target discovery in osteosarcoma |
| RFA | 2024 | Rare Cancers | Memorial Sloan Kettering Cancer Center | Integrative protoegenomics for elucidation of tumor specific cell surface proteomes in ultra-rare cancers |
| RFA | 2024 | Rare Cancers | Duke University | Defining Actionable Opportunities in Malignant Phyllodes via Genomic Profiling |
| BAA | 2024 | Pediatric Oncology | Purdue University | Advancing bispecific engagers for NK immunotherapy in pediatric gliomas |
| BAA | 2023 | Rare Cancers | Ontada | Leveraging Real World Data to Investigate the Natural History of Rare Cancers Treated in the US Community Oncology Setting to Provide Clinical Context to Inform Future Research |
| CERSI | 2023 | Real World Data | University of North Carolina | Utilizing the UNC Clinical Data Warehouse for Assessing Efficacy, Toxicity, and Dose-Response Relationships of Molecularly Targeted Therapies in Real-World Patients |
| CERSI | 2023 | Trial designs, endpoints and statistical methodologies | Duke University | Principal stratification methods and software for intercurrent events in clinical trials |
| RFA | 2023 | Rare Cancers | Fred Hutchinson Cancer Center | SmartCore Technology: Using AI and Patient Tissue to Identify Potential Cancer Therapies for Ultra-rare Cancers |
| BAA | 2023 | Precision Oncology | Stanford University | Development of neuroblastoma tissue diagnostic utility through fusion of deep learning-based image analytics and targeted multiplex proteomics |
| 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 |
| 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 |