This program utilizes a UH3 cooperative agreement mechanism to support a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system (CNS) disorders and better understand the human brain. Studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical study should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical study is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use, yet is critical to enable next-generation diagnostic or therapeutic devices.
Projects appropriate for this program must have completed all non-clinical testing necessary to obtain an Investigational Device Exemption (IDE) for a Significant Risk (SR) clinical study or obtained Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) clinical study prior to entry. In addition, projects must obtain the necessary approval to conduct the clinical study prior to entry or within the first year of the award.
A companion program, RFA-NS-16-009, will support non-clinical testing required to obtain the necessary approvals to conduct the clinical study, in addition to a singular clinical study.
This program is milestone-driven and involves NIH program staff's participation in developing the project plan, monitoring the research progress, and making go/no-go decisions. NIH staff will also provide assistance to academic investigators in familiarizing them with the clinical device development process and the criteria needed to advance therapeutic leads and diagnostics to the clinic. The expectations of the program are in line with those of industry in regards to advancing devices through the translational developmental pipeline. As such, an inherent high rate of attrition is expected within this program.
For entry to the program, projects should have:
- Comprehensive Supporting Data: Proof-of-concept data of device function are required using a prototype device equivalent to the final device design anticipated for clinical testing, ideally obtained using an in vivo model representative of the intended patient population;
- Completed all non-clinical testing necessary for approval to conduct the clinical study;
- A compelling case for a successful IDE submission to support the clinical component, or IRB approval for an NSR study, within the first year of the award;
- Overall device development plan, including timeline for contact and interaction with appropriate regulatory bodies, clinical considerations, and a needs assessment; and
- Identification of one or more clinically meaningful device outcome measures based on input from both clinicians and patients
The program will support a small clinical study to answer key questions about the function or final design of a device. Examples of studies that can be proposed during the clinical phase include, but are not limited to:
- Optimization of the device design with respect to the human functional anatomy;
- Identification of the most simple, reliable, and cost effective device configuration for more advanced clinical trials and eventual market approval;
- Basic proof-of-concept testing in human patients;
- Studies of the key physiological variables that may impact the function of the device in humans; and
- Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function