Clinical Trials Innovation Unit (CTIU)

A blue dotted background and bold white text reading "CLINICAL TRIALS INNOVATION UNIT."

The NCI Clinical Trials Innovation Unit (CTIU) was launched in February 2023 to advance innovative science, trial designs, and operational efficiencies for high-priority clinical research needs. It includes experts from NCI, the Food and Drug Administration (FDA), and the extramural cancer clinical research community.

The CTIU was created in recognition of the need to accelerate clinical testing of new cancer prevention, diagnostic, treatment, and survivorship approaches. Clinical trial designs and execution mechanisms can be excessively burdensome to patients and health care providers. Trials are expensive to launch and operate, and the number of tests, lab work, and other protocol requirements can extend study timelines; induce patient, caregiver, and researcher fatigue; and delay delivery of potentially effective cancer prevention and treatment approaches. Overly complex study designs can make participation challenging for many people, especially those who are historically underrepresented in clinical trials, resulting in their opting out of or not finishing trials.

The few high-priority projects that are selected for the CTIU are expected to be particularly suitable to innovative approaches with uncomplicated designs, using focused endpoints and data collection. CTIU trials will be conducted within NCI’s National Clinical Trials Network (NCTN) and have a streamlined evaluation and activation process.

Examples of innovation may include:

Studies with novel designs, such as those with relaxed eligibility criteria, novel endpoints, pragmatic approaches, or other methods to deliver high-impact results to patients efficiently, effectively, and equitably
New technologies or biomarkers that have been analytically validated and have good initial data supporting clinical utility
Strategies that allow for more effective or equitable care
New data collection methodologies or technologies that leverage existing electronic data systems

During its pilot phase, the CTIU accepted proposals from extramural researchers at member institutions and affiliates within NCTN for its first round of proposals. We anticipate that future proposals will include a broader array of collaborators beyond those at NCTN institutions.

Questions about the CTIU may be sent to nciclinicaltrialsinnovationunit@mail.nih.gov.

CTIU Leadership

The CTIU includes representatives from NCI, FDA, and NCTN. The co-directors are Sheila Prindiville, M.D., M.P.H., director of the NCI Coordinating Center for Clinical Trials, and Michael Morris, M.D.