Funding Imaging-based Clinical Trials
Imaging is used in oncology clinical trials for various indications and the type of study design/phase needed to evaluate the imaging in an indication will vary. For instance, NCI supports clinical trials through grants, cooperative agreements, and contracts, in the research fields of new imaging devices, imaging agent development, and image-guided intervention, systems, methodologies, and therapies that demonstrate their utility in screening and early detection, diagnosis and staging, monitoring of response, and prognostic and predictive biomarker-based evaluation1,2. This includes opportunities to:
- Optimize the dose, safety, tolerability or pharmacokinetics of an imaging agent or intervention in a target population
- Produce sufficient evidence (e.g., imaging biomarker activity, pharmacodynamic response, target engagement, dose-response trends) in a human proof of concept trial
- Assess imaging modalities utilized for quantitative imaging assessment (e.g., PET and CT, instrument calibration techniques, post-processing software algorithms), to improve accuracy and aid in clinical decision-making
- Guide oncology treatment decisions and improve efficiency and success rates in treatment trials
- Select or rank the best of two or more potential imaging interventions, technologies, or dosing regimens to be evaluated in a subsequent trial, based on tolerability, safety data, biological activity, or preliminary clinical efficacy (e.g., a futility trial)
- Conduct exploratory IND studies with less preclinical toxicity data or less micro-dosing of investigational agents than usually required for traditional first in human studies to improve the trial design and efficiency in subsequent trials
1 Erich Huang, Frank Lin, Lalitha K. Shankar. Acad Radiol 2017; 1036-1049.
2 Frank Lin, Erich Huang, Lalitha K. Shankar. Acad Radiol 2017; 24:1027-1035.
Study-Type Funding Opportunity Announcements (FOA): NIH has instituted a policy that requires all applications involving one or more clinical trials to be submitted through an FOA specifically designed for clinical trials. The purpose of this policy is to improve the ability for NIH to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with applications, and uniformly apply trial-specific review criteria. Each FOA states if a clinical trial(s) is required, optional, or not accepted for funding through that mechanism.
PAR-21-033: National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)
These FOAs support a range of clinical trial evaluations designed to improve the diagnosis and treatment of cancer in areas of common and unmet need. This includes projects with clinical and basic science research aims, testing the safety and effectiveness of imaging agents, systems, and image-guided interventions as well as methods to explore fundamental mechanisms of cancer biology or pathways (i.e., mechanistic and ancillary trials). However, NCI only funds Phase 3 imaging trials through, and collaborations with, its National Clinical Trials Network.
NCI does not participate in the NIH Clinical Trial Required Parent Research Grant FOAs (R01 and R21) that covers investigator-initiated research or mechanistic clinical trials. Applications for mechanistic clinical trials may be submitted to the NCI PAR-18-560 or PAR-18-020. Visit the NCI’s Division of Extramural Activities funding opportunities website for a current list of Funding Opportunity Announcements.
Applicants are also encouraged to review the NIH Guide notice NOT-OD-12-130 to understand the differences between delayed onset or delay start clinical trials. Investigators are required to provide a justification at the time of submission stating why it is a delayed onset study. This policy also gives instructions on how to seek prior approval by NCI for delay onset trials.