OCE Professional Education and Resources 2024
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Project Facilitate
OCE's Project Facilitate supports oncology healthcare professionals in submitting Expanded Access requests to the FDA. The project offers assistance via phone or email during business hours, and its staff reviews all CDER oncology single-patient Expanded Access applications.
In 2024, Project Facilitate managed 364 phone inquiries and processed 761 single-patient Expanded Access applications. The project emphasized transparency by presenting key metrics through a formal abstract and presentation at the American Society of Clinical Oncology 2024 Annual Meeting.
Project Facilitate expanded its external outreach by delivering presentations and training sessions to organizations such as Hawaii Health and the U.S. Department of Veterans Affairs National Oncology Program. The project marked a significant milestone with a published article in The ASCO Post, highlighting five years of programmatic improvements and growth.
Demonstrating its commitment to education, Project Facilitate continued to mentor future leaders by participating in the FDA-AACR Fellowship program.
Project Socrates
Project Socrates is OCE's professional education and engagement effort, and in 2024, it welcomed over 250 trainees and fellows through a variety of educational workshops and fellowship programs. These efforts included collaborations with the American Society of Clinical Oncology, American Association for Cancer Research, American Society of Hematology, American Statistical Association, and many others.
The OCE Regulatory Science Online Lecture Series added four new episodes, all of which are freely available with accompanying audio and slides. OCE Insights published three new updates, covering topics such as Project Facilitate, the Conversations on Cancer series exploring spirituality, and the Project 5 in 5 initiative.
Project Socrates continued to strengthen its international collaborations, engaging with regulators at the European Medicines Agencies and the Heads of Medicines Agencies, and providing links to webinars addressing regulatory considerations in Europe.
OCE also hosted Drs. James Armitage and Nancy Davidson for the Icons in Oncology Distinguished Lecture Series, with recordings of their talks available online.
Project 5 in 5
Project 5 in 5 was an OCE crowdsourcing initiative to ultimately identify 5 clinically relevant questions that can be answered through use of pragmatic clinical trials, using FDA-approved oncology therapies, over the next 5 years. The crowdsourcing initiative ran from May 5 through July 5, 2024, and was open for anyone to submit idea.
As a result of the initiative, the OCE:
- Convened several external stakeholders to discuss incorporation and implementation of pragmatic elements in clinical trials.
- Held a public crowdsourcing event, with 34 ideas received.
- Presented the project as part of a larger discussion on pragmatic trial elements at the Friends of Cancer Research Annual Meeting.
- Is drafting a manuscript for eventual publication.
OCE Guidance
OCE led the development of seven draft guidance documents and three final guidance documents for oncology drug development in 2024. See all current oncology guidance documents at OCE Guidance Documents.
OCE Publications and Approval Announcements
The OCE’s strong support for publications by FDA oncology/hematology staff continued in 2024, resulting in 74 articles in scientific journals. This included 26 research papers, 23 FDA approval summaries, and 25 regulatory perspectives.
OCE’s Communications Team works with FDA clinical reviewers to issue approval announcements for some oncology/malignant hematology approvals; 60 of these were posted in 2024.