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HEAL INITIATIVE: Development and validation of remote or patient wearable device derived objective biosignatures or functional assessments to monitor pain for use as endpoints in clinical trials (UG3/UH3 - Clinical Trial Optional)

National Institutes of Health

The purpose of this Notice of Funding Opportunity (NOFO) is to promote the discovery, development, and validation of real-world digital endpoints derived from data generated by existing remote or wearable devices. These endpoints will be used for monitoring the experience of pain, its progression, response to interventions, and impact on quality of life. In this NOFO, endpoints refer to biosignatures obtained from functional and physiological assessments captured by remote or wearable devices. Development of digital endpoints will involve clinical research using existing wearable or remote devices, with a specific focus on selecting and validating novel measurements as appropriate digital endpoints for pain assessment. The proposed digital endpoints may focus on a specific pain condition or encompass multiple pain conditions. Applications aiming to identify digital endpoints across various pain conditions should involve Multiple Principal Investigator (MPI)-led teams that represent each relevant pain condition and associated clinical networks. These teams should collaborate to discover, develop, and validate digital endpoints that accurately measure pain and related outcomes, such as quality of life or appropriate pain-related functional measures. In addition, the applicant should include experts in digital technology, data analysis, and advanced statistical methods to handle real-world data. Applicants must establish centralized resource groups responsible for coordinating clinical trials, standardizing sample or data collection methods, technology development, statistical analysis, and algorithm development across all pain conditions under investigation. For applications focused on developing digital endpoints for a single pain condition, MPI-led teams with cross-functional expertise should be included, along with centralized resource groups responsible for coordinating clinical trials, standardizing sample or data collection methods, technology development, and statistical analysis. Furthermore, the inclusion of people with lived experience in the team is required to incorporate patient perspectives, concerns, and valuable input regarding the relevance and acceptability of digital measurements in the study. The final products of this effort would be algorithms and software designed to analyze data from existing remote or wearable technologies. The goal is to demonstrate that digital biosignatures or digital functional assessments, serving as digital endpoints, are sensitive and objective measures of clinical benefit.

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