The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) invites academic and patient advocate researchers to propose research questions for Project Collaborate, a unique crowdsourcing initiative running through September 26. This represents a rare opportunity to leverage one of the most comprehensive oncology clinical trial databases available while contributing to regulatory science that shapes cancer treatment.
The Opportunity
The OCE has an established track record of publishing impactful pooled analyses using comprehensive clinical trial data sets submitted to the FDA as part of marketing applications. Now the OCE is inviting external research questions that may advance oncology regulatory science and benefit the broader cancer research community.
What’s Available
The following topics are available:
• Demographics and baseline disease characteristics;
• Efficacy endpoints (eg, response rates, survival data, biomarkers);
• Comprehensive adverse event and laboratory data;
• Data on drug exposure and treatment modifications due to toxicity.
The Collaboration
Selected researchers may work directly with FDA scientific staff throughout the entire research process—from study design and analysis to manuscript preparation and publication. Although there will not be direct access to the proprietary data, the selected researchers will be considered important members of the research team.
How to Participate
Submit a research question that addresses high-priority needs in oncology regulatory science. The OCE will review all submissions and select projects for internal research coordination.
To learn more and submit a question, visit https://shareyourvoice.ideascalegov.com/c/shareyourvoice/landing.
