FDA initiates Project 5 in 5 to progress use of pragmatic clinical trials in oncology

The US FDA’s Oncology Center of Excellence has launched a crowdsourcing initiative to identify five clinically relevant questions regarding FDA-approved oncology therapies to be addressed through pragmatic clinical trials over the next five years.

As the US FDA advances patient-centric clinical trial innovation, they have announced a new project towards improving the understanding of pragmatic trials in generating evidence in oncology. Called ‘Project 5 in 5’, the initiative is being led by the FDA Oncology Center of Excellence (OCE), who is crowdsourcing ideas for five clinically relevant questions that can be answered through use of pragmatic clinical trials. Oncology providers, researchers, patients, caregivers, and advocacy groups are encouraged to participate and the initiative will run from May 5 until July 5, 2024. The ideas generated for pragmatic clinical trials will be reviewed by FDA hematologists, oncologists, and clinical experts and shared with the oncology community for discussion. The FDA will not be involved in the conduct of the studies; the studies will be conducted by the National Cancer Institute (NCI), NCI-supported clinical trials cooperative groups, advocacy organizations, pharmaceutical companies, and other potential funders, where appropriately identified by the FDA.