The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) recently announced a new initiative called “Project 5 in 5.” Project 5 in 5 is a crowdsourcing initiative to ultimately identify five clinically relevant questions that can be answered through use of pragmatic clinical trials, using FDA-approved oncology therapies, within 5 years. The OCE invites anyone interested to submit ideas.
Richard Pazdur, MD
Richard Pazdur, MD, Director of OCE, commented: “This project is aimed at pragmatic trials in oncology, and it involves the oncology community to suggest to us important clinical trials that you want done.” The resulting ideas will be shared with government agencies, cooperative groups, and others who may be interested in implementing these pragmatic clinical trials.
The OCE is serving as the convener but will not be involved in the implementation or conduct of the clinical trials themselves. This initiative is important to accelerate patient-centric clinical trial innovation.
In general, pragmatic clinical trials are those clinical trials that do the following:
- Focus on efficacy or safety;
- Streamline data collection and study design by collecting only those data necessary to answer the research question;
- Use the most straightforward endpoint feasible (ie, overall survival);
- Decrease burden for trial participants, investigators, and sponsors;
- Incorporate design elements more reflective of routine clinical practice;
- Take advantage of functional efficiencies (eg, fewer and/or broader and/or less-restrictive eligibility criteria, flexibilities in trial delivery and outcome measurement);
- Improve trial participation, increase diversity, facilitate rapid enrollment, and reduce attrition;
- Generate evidence representative of the general population affected by the clinical question.
To submit your pragmatic oncology clinical trial idea to Project 5 in 5, visit https://shareyourvoice.ideascalegov.com/c/landing.
