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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 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 MechanismFYPrimary Scientific Research AreaOrganizationProject Title
CERSI2024Precision OncologyJohns Hopkins UniversityIntegrative liquid biopsy approaches to capture minimal residual disease and inform therapeutic decisions for patients with resectable cancers
CERSI2024Precision OncologyJohns Hopkins UniversityDetection of circulating tumor DNA in a surgery-sparing approach for patients with mismatch repair deficient colorectal cancer
CERSI2024Trial designs, endpoints, and statistical methodologiesJohns Hopkins UniversityNavigating immortal time bias: impacts of index date selection and analytic techniques in ECTs
CERSI2024Real World DataUniversity of North CarolinaIndex date selection for external comparators in assessment of cancer therapies
CERSI2024Rare CancersUniversity of California, San FranciscoComprehensive surfaceome target discovery in osteosarcoma
RFA2024Rare CancersMemorial Sloan Kettering Cancer CenterIntegrative protoegenomics for elucidation of tumor specific cell surface proteomes in ultra-rare cancers
RFA2024Rare CancersDuke UniversityDefining Actionable Opportunities in Malignant Phyllodes via Genomic Profiling
BAA2024Pediatric OncologyPurdue UniversityAdvancing bispecific engagers for NK immunotherapy in pediatric gliomas
BAA2023Rare CancersOntadaLeveraging 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
CERSI2023Real World DataUniversity of North CarolinaUtilizing the UNC Clinical Data Warehouse for Assessing Efficacy, Toxicity, and Dose-Response Relationships of Molecularly Targeted Therapies in Real-World Patients
CERSI2023Trial designs, endpoints and statistical methodologiesDuke UniversityPrincipal stratification methods and software for intercurrent events in clinical trials
RFA2023Rare CancersFred Hutchinson Cancer CenterSmartCore Technology: Using AI and Patient Tissue to Identify Potential Cancer Therapies for Ultra-rare Cancers
BAA2023Precision Oncology Stanford UniversityDevelopment of neuroblastoma tissue diagnostic utility through fusion of deep learning-based image analytics and targeted multiplex proteomics
BAA2022Real World DataBrigham and Women’s Hospital, Harvard Medical SchoolCalibrating RWE studies in oncology against randomized trials
BAA2022Real World DataAlliance NCTNReal World Collection of Radiographic Images and Treatment Emergent Adverse Event Data: Next Phase Development of ICAREdata Research Infrastructure
CERSI2022Immuno-oncology and Precision OncologyUniversity of California San FranciscoWhole exome sequencing to determine risk of immune related adverse events and predict treatment response in patients on immune checkpoint inhibitors
CERSI2022Patient Focused Drug DevelopmentMayo ClinicQualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients
CERSI2022Patient Focused Drug DevelopmentMayo ClinicLongitudinal analysis & visualization of patient-reported physical function & symptom data 
CERSI2022Precision OncologyUniversity of MarylandPrecision Medicine Utilizing Bacillus Calmette-Guérin Vaccine in Non-Muscle Invasive Bladder Cancer
CERSI2022Precision OncologyJohns Hopkins University Development of a precision oncology decision support platform to enhance genotype-driven clinical trial recruitment and decentralized personalized medicine approaches
CERSI2022Precision OncologyJohns Hopkins University Non-invasive Integrative Liquid Biopsy Approaches for Precision Immuno-oncology
CERSI2022Real World Data and Precision OncologyYale University Real-world outcomes of novel PET imaging tracers for prostate cancer
BAA2021Real World DataCardinal HealthDevelopment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies
BAA2021Pediatric OncologyChildren's Hospital of PhiladelphiaPediatric High-Risk Cancer Preclinical Model Resource
BAA2021Patient Focused Drug DevelopmentNorthwestern UniversityEvaluation of a Global Item for Side Effect Bother
BAA2021Trial designs, endpoints and statistical methodologiesMedical College of WisconsinCommensurate prior models accommodating historical controls for clinical trials with matched and/or interval-censored data
BAA2021Pediatric OncologySt. JudeModeling Pediatric Solid Tumors and the Tumor Microenvironment
CERSI2021Precision OncologyUniversity of MarylandAn integromic signature for distinguishing malignant from benign growths detected on screening CT scans
BAA2020Patient Focused Drug DevelopmentDuke UniversityEvaluating Physical Functioning Using Patient-Reported Outcome Measures: How does the question form and recall period influence patients’ interpretation?
CERSI2020Patient Focused Drug DevelopmentMayo ClinicQuantifying physical function in cancer patients undergoing chemotherapy using clinician-reported, patient-reported, and wearable device data sources
CERSI2020Trial designs, endpoints and statistical methodologiesMayo ClinicBayesian adaptive basket trial designs for neoantigen based immunotherapy with borrowing strength across subpopulations within the trial and from external controls

 

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