Clinical Trials Innovation Unit (CTIU)
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 CTIU will consider proposals for clinical trials from the extramural cancer research community about three times a year. The first proposal submission deadline is June 12, 2023. Initially, the CTIU will accept proposals from extramural researchers at member institutions and affiliates within NCI’s National Clinical Trials Network (NCTN) .
The few high-priority clinical trials 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 NCTN and have a streamlined evaluation and activation process.
We anticipate that future proposals may include a broader array of collaborators beyond those at NCTN institutions.
Research Community Input
Currently, the CTIU seeks the input of the extramural cancer research community on ways to bring new cancer treatments to people more quickly than we have been able to do through our current cancer clinical trial process.
Proposals may include:
- Clinical trials that investigate innovative therapeutic agents that have known safety data and show signs of efficacy
- 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
Proposals should briefly explain, in one or two pages, the study rationale and design and why it is innovative, collaborative, and impactful—basically, why it should be considered via the CTIU (rather than another mechanism).
If you are a researcher at an NCTN institution or affiliate and want to learn more about the CTIU proposal submission process for your NCTN group, you may contact the groups directly:
- Alliance for Clinical Trials in Oncology: allianceCTIU@alliancenctn.org
- Canadian Cancer Trials Group: CTIU_PROPOSALS@ctg.queensu.ca
- Children’s Oncology Group: CTIUrequests@childrensoncologygroup.org
- ECOG-ACRIN Cancer Research Group: CTIUproposals@ecog-acrin.org
- NRG Oncology: NRG-Protocols@nrgoncology.org
- SWOG Cancer Research Network: firstname.lastname@example.org
Other questions may be sent to the CTIU directly at: email@example.com
The CTIU includes representatives from NCI, FDA, NCTN, and NCORP. 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., Prostate Cancer Section head at Memorial Sloan Kettering Cancer Center, and special advisor to the NCI director.