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                Oncology Center of Excellence

Oncology Center of Excellence

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          Oncology Center of Excellence
          OCE-Funded Active Extramural Research ProjectsOncology Center of Excellence OCE-Funded Active Extramural Research Projects
  
  	
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    PrintThe 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 TitleBAA
			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 cancersBAA
			2022
			Real World Data
			Brigham and Women’s Hospital, Harvard Medical School
			Calibrating RWE studies in oncology against randomized trialsBAA
			2022
			Real World Data
			Alliance NCTN
			Real World Collection of Radiographic Images and Treatment Emergent Adverse Event Data: Next Phase Development of ICAREdata Research InfrastructureCERSI
			2022
			Health Equity
			Yale University
			A positive deviance approach for representing women, older adults and patients identifying as racial and ethnic minorities in oncology researchCERSI
			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 inhibitorsCERSI
			2022
			Patient Focused Drug Development
			Mayo Clinic
			Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patientsCERSI
			2022
			Patient Focused Drug Development
			Mayo Clinic
			Longitudinal analysis & visualization of patient-reported physical function & symptom dataCERSI
			2022
			Oncology Safety and Health Equity
			Stanford University
			Role of Genomic Ancestry in Chemotherapy-Induced Cardiotoxicity Vaccine in Non-Muscle Invasive Bladder CancerCERSI
			2022
			Precision Oncology
			University of Maryland
			Precision Medicine Utilizing Bacillus Calmette-Guérin Vaccine in Non-Muscle Invasive Bladder CancerCERSI
			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 approachesCERSI
			2022
			Precision Oncology
			Johns Hopkins University
			Non-invasive Integrative Liquid Biopsy Approaches for Precision Immuno-oncologyCERSI
			2022
			Real World Data and Precision Oncology
			Yale University
			Real-world outcomes of novel PET imaging tracers for prostate cancerBAA
			2021
			Real World Data
			Cardinal Health
			Development of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World StudiesBAA
			2021
			Pediatric Oncology
			Children's Hospital of Philadelphia
			Pediatric High-Risk Cancer Preclinical Model ResourceBAA
			2021
			Patient Focused Drug Development
			Northwestern University
			Evaluation of a Global Item for Side Effect BotherBAA
			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 dataBAA
			2021
			Pediatric Oncology
			St. Jude
			Modeling Pediatric Solid Tumors and the Tumor MicroenvironmentCERSI
			2021
			Real World Data
			University of Maryland
			Building Capacity for Research on Cancer and Aging: The UMGCCC-Medicare DatabaseCERSI
			2021
			Precision Oncology
			University of Maryland
			An integromic signature for distinguishing malignant from benign growths detected on screening CT scansBAA
			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 sourcesCERSI
			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

Further Information

OCE Scientific Collaborative
	FDA Broad Agency Announcement: Frequently Asked Questions for Oncology Researchers

                                                                                  Content current as of:
      01/18/2024Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community
 
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