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Related Announcements

PAR-21-340 - Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed)

NOT-TR-23-002 - Notice of Termination for NOT-TR-22-023 NCATS Notice of Special Interest (NOSI): Research through NCATS’ Clinical and Translational Science Award (CTSA) Program: High Impact Specialized Innovation Programs (RC2)

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The High Impact Specialized Innovation Programs (SIPs) support the development and demonstration of unique hub capabilities, research platforms and/or resources to address critical gap areas and/or roadblocks in clinical and translational science at awarded UM1 Clinical and Translational Science Awards (CTSA) Program Hubs (PAR-21-293). Successful programs supported through this funding opportunity are expected to lay a strong foundation for future adoption and/or dissemination of capabilities to additional CTSA Program Hubs.

The purpose of this Notice of Special Interest (NOSI) is to provide topics of interest for critical need/gap areas in Clinical and Translational Science for applications in response to Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed) (PAR-21-340).

Topics of Interest

The National Center for Advancing Translational Sciences (NCATS) is issuing this Notice to highlight interest in receiving grant applications focused on the following area:

Digital Health Technologies (DHT) that can be adopted and implemented for clinical and translational research. These technologies and approaches enable generation of novel data types that can give a more robust assessment of human health as well as subsequent perturbations due to disease and/or therapeutic intervention. DHTs include: wearables, mobile health (mHealth apps), ambient sensors, health information technology (IT), and other software as a medical device (SaMD) solutions. Digital health approaches incorporate any combination of computing platforms, connectivity, software, and/or sensors to generate digital biomarkers.

Appropriate topics include, but are not limited to, the following:

• DHT platforms, tools, or resources to help de-centralize clinical trials: leveraging wearables and other out-of-clinic objective measures of individual patients in remote or underserved communities;
• Procedures, methods, and clinical workflow integration that enable the rapid dissemination of DHT to multiple diverse communities and/or to geographically isolated, medically underserved, and otherwise vulnerable populations (e.g., community centered design);
• DHT validation resources for using rigorous research methods (e.g., the use of gold-standard comparators) to evaluate proposed digital health solution(s) and medically actionable signal(s);
• DHT platforms, tools, or resources to enable more objective understanding, earlier mitigation, and/or longer-term monitoring for adverse events or side effects from treatment;
• DHT platforms, tools, or resources for adaptive clinical trial design (proactive patient stratification) by incorporating novel (digital) endpoints/surrogate markers;
• Platforms, tools, or resources to enable DHT as complement to other assays or validated biomarkers with AI/ML approaches to generate predictive correlatives (e.g., digital phenotype) for measuring response to treatment interventions or prognosticating response;
• Integration, predictive analysis, and visualization of data from multiple DHTs and/or regulatory resources (e.g., in silico patient avatars);
• DHT platforms, tools, or resources to link, combine, and analyze multiple data streams (e.g., real-time surveys, sensors, wearables, GPS/GIS, home-based monitors, clinical trials data, etc.) to address pressing population and public health issues;
• Tools, platforms and/or applications to collect and validate DHT-derived data for its use as Real-World Data and subsequent linking to other sources (e.g., other reliable clinical and/or public health data sources) to support Real-World Evidence; and
• Enhancing clinical and translational research, including the ability to collect and analyze large data sets and implement innovative DHT solutions that improve human health through Real-World Data and Real-World Evidence.

SIPs and resulting technologies/tools/expertise/applications in response to this NOSI are expected to adhere to all data and resource sharing policies outlined in PAR-21-340 and embrace a culture of Open Science and Data Sharing that promote the Findable, Accessible, Interoperable, and Reusable (FAIR) principles (see: NIH Strategic Plan for Data Science).

The list of topics and examples provided above represent gap areas of interest by NCATS but this is not an exhaustive list; applicants should refer to the funding opportunity announcement PAR-21-340 and Application Information for PAR-21-293: Clinical and Translational Science Award (UM1 Clinical Trial Optional) under RC2 Companion Application for information about other topic areas and examples.

Application and Submission Information

This notice applies to due dates on or after January 13, 2023 and subsequent receipt dates through January 12, 2024.

Submit applications for this initiative using the following funding opportunity announcements (FOA) or any reissues of this announcement through the expiration date of this notice.

• PAR-21-340 High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-TR-23-003” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

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