OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD, Associate Director for Education, OCE; Donna R. Rivera, PharmD, MS, Associate Director for Pharmacoepidemiology, OCE; Martha B. Donoghue, MD, Deputy Director, Division of Oncology 2, Office of Oncological Diseases (OOD), Center for Drug Evaluation and Research (CDER) and Acting Associate Director for Pediatric and Rare Cancer Drug Development, OCE; Gregory H. Reaman, MD, FASCO, Associate Director for Pediatric Oncology, OCE; Rajeshwari Sridhara, PhD, Consultant, OCE; Julia A. Beaver, MD, Chief of Medical Oncology, OCE, and Acting Deputy Director, OOD, CDER; Paul G. Kluetz, MD, Deputy Director of the OCE and Acting Supervisory Associate Director, OOD, CDER ; Marc R. Theoret, MD, Deputy Director of the OCE and Acting Supervisory Director, OOD, CDER; and Richard Pazdur, MD, Director of the OCE, discuss the OCE extramural research funding program for applied regulatory science research.
Extramural Research Projects
Why does OCE fund extramural research?
OCE conducts many internal research projects that focus on questions emerging from regulatory review. These projects include building a deeper understanding of the safety and efficacy of oncology therapeutics as well as generating insights into subpopulations, endpoints, clinical outcome assessment data, and other drug-development issues. OCE recently began funding a limited number of projects with outside investigators (extramural projects). Funding extramural research provides new opportunities for OCE staff to engage with academic experts to investigate research questions with regulatory significance.
What type of extramural research does OCE fund?
OCE has a limited amount of funding available to support applied research, which aims to solve specific, practical problems rather than expanding general knowledge. We identified nine scientific interest areas and one cross-cutting topic where OCE is actively engaging in research. These scientific interest areas are summarized on the OCE Scientific Collaborative Web page; however, OCE is interested in proposals for all applied research questions relevant to the regulatory review of oncology therapeutics.
The specific scientific interest areas follow:
- Cell/gene and personalized neoantigen-based therapies for cancer
- Health equity and special populations in oncology drug development
- Immuno-oncology
- Oncology patient-focused drug development
- Oncology trial designs, endpoints, and statistical methodologies
- Oncology safety
- Pediatric oncology
- Precision oncology
- Rare cancers
- Oncology real-word data utilization.
Mechanisms of Funding
How does OCE fund extramural research?
OCE uses several mechanisms to fund extramural research, including the FDA Broad Agency Announcement (BAA) and the Centers of Excellence in Regulatory Science Innovation (CERSI) program.
The BAA is an FDA-wide funding mechanism that solicits research proposals from external institutions. BAA proposals are reviewed in two stages by FDA experts for scientific and technical merit, program relevance, offeror capability and budget, and they may result in a research contract. BAA 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 six institutions selected through a competitive process: Johns Hopkins, University of Maryland, UCSF-Stanford, and Yale–Mayo Clinic. FDA staff may propose projects with investigators at these universities.
Recently Funded Projects
What projects has OCE recently funded?
The FDA recently funded six new BAA projects and two new CERSI projects noted here. These projects join OCE’s existing extramural portfolio1:
- A project with the Children’s Hospital of Philadelphia to generate new patient-derived xenograft models for rare pediatric cancers and create a platform to facilitate patient-derived xenograft model sharing with the scientific community
- A project with St. Jude Children’s Research Hospital to develop and characterize new orthotopic xenograft models of pediatric solid tumors and explore new approaches to model the tumor microenvironment
- A project with the Medical College of Wisconsin to develop new approaches to estimate causal treatment effects in hematologic oncology trials in the presence of multiple subsequent therapies
- A project with the Medical College of Wisconsin to explore commensurate prior models in using historical controls for clinical trials with interval-censored data
- A project with Cardinal Health to explore a novel methodology for developing clinically meaningful real-world endpoints to assess response to lymphoma treatment
- A project with Northwestern University evaluating a patient-reported global item for side effect bother to analyze its utility to inform tolerability. The global side effect bother item will also be compared with other patient- and clinician-reported outcome measures frequently collected in oncology clinical trials.
OCE also funded two new research projects with CERSI investigators:
- A project with the University of Maryland CERSI to build capacity for cancer and aging research with a specific focus on disparities by developing a database linking registry, claims, and electronic health record data for patients in the University of Maryland comprehensive cancer center
- A project with the University of Maryland CERSI to develop and test the ability of a new biomarker panel to distinguish malignant from benign pulmonary nodules identified in low-dose CT scans.
To Learn More
How can I learn more about OCE research opportunities?
You can visit the OCE Scientific Collaborative Web page (https://www.fda.gov/about-fda/oncology-center-excellence/oce-scientific-collaborative) to learn more about OCE scientific interest areas, find the latest BAA announcement, and Frequently Asked Questions for investigators considering submitting a BAA application in the area of oncology. White papers are due on January 21, 2022, to be considered for funding in fiscal year 2022. For more information about all OCE activities, follow us on Twitter @FDAOncology or contact us via e-mail at FDAOncology@fda.hhs.gov.
DISCLOSURE: All authors reported no conflicts of interest.
Reference
1. Schneider J, Gong Y, Goldberg K, et al: The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology. Clin Cancer Res. April 28, 2021 (early release online).
