FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

FDA Oncology Center of Excellence director Angelo De Claro says the center has retained its core regulatory experts despite staffing reductions across the agency and is pursuing new collaborations with the Department of Veterans Affairs and National Cancer Institute to modernize oncology clinical trials.

Speaking during an 11/10 fireside chat at the Friends of Cancer Research annual meeting, De Claro acknowledged that the center continues to face a substantial workload, estimating that oncology accounts for about 30% to 40% of FDA's regulatory workload.

The discussion, moderated by Friends of Cancer Research President and CEO Jeff Allen, addressed staffing changes following leadership departures and workforce reductions that Allen characterized as approximately 20% across FDA's drug center.

De Claro said OCE has retained the expertise needed to provide consistent regulatory advice across oncology disease areas. “Workload is heavy," he said, adding that the demands have encouraged OCE to develop review efficiencies through programs such as Assessment Aid and Real-Time Oncology Review.

De Claro, who assumed leadership of OCE in January, said he was satisfied with the center's current staffing and leadership.

Project Orbis Reports 750 Regulatory Actions

De Claro also provided updated figures for Project Orbis, FDA's international oncology review collaboration program, which he helped establish in 2019. The program now includes nine full member countries, including the U.S., and has handled more than 200 applications, generating approximately 900 regulatory submissions and 750 regulatory actions across participating countries, he said.

OCE has expanded the program beyond applications considered relatively straightforward for approval and has received inquiries about extending the Project Orbis framework to other disease areas.

He also highlighted Project Facilitate, OCE's expanded access assistance program, saying FDA generally approves approximately 800 to 900 expanded access requests annually for oncology indications.

New VA and NCI Collaborations

Discussing Operation Trialblazer, the HHS initiative intended to accelerate early clinical development in the U.S., De Claro disclosed that OCE recently executed a memorandum of understanding with the Department of Veterans Affairs to explore collaborative projects. Initial areas include pharmacogenomics, with additional potential work involving expanded access and geriatric oncology. OCE also is working with NCI and other federal partners on clinical trial decentralization and streamlining trial data collection.

De Claro suggested that some clinical trial requirements attributed to FDA are not actually mandated by the agency, citing biopsies and other assessments that sponsors or investigators may incorrectly believe FDA requires.

He encouraged stakeholders to review agency guidance and challenge unnecessary requirements, noting that FDA has supported broader eligibility criteria to increase patient access to clinical trials.

De Claro said OCE's experience with streamlined nonclinical testing, including efforts to reduce animal use and improve starting-dose selection, positions the center to play an important role in Operation Trialblazer.

New Oncology Endpoints

The OCE director also discussed FDA's evolving approach to novel oncology endpoints, including minimal residual disease (MRD) negativity in multiple myeloma and circulating tumor DNA measurements in solid tumors.

He said regulatory acceptance of MRD as an endpoint in multiple myeloma followed years of collaboration with professional organizations, evidence development and discussion at an FDA advisory committee meeting. De Claro emphasized the importance of early engagement with FDA when developing novel endpoints and trial designs.

He said OCE initiatives including Project Endpoint and Project Pragmatica remain operational to address emerging regulatory science questions.

Looking ahead to OCE's tenth anniversary in 2027, De Claro said he hopes the center's experience with regulatory innovation and collaboration can inform practices elsewhere in FDA.