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  1. Science and Research Special Topics

Digital Health Technologies for Drug Development: Demonstration Projects

To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects on Digital Health Technologies (DHTs) through multiple venues and programs including FDA’s Broad Agency Announcement, CERSI Program, and other funding opportunities.

Below lists some of our current FDA-funded projects on DHTs:

  • Measuring Digital Clinical Endpoints in Huntington's Disease (MEND-HD)

    Awardee: University of Rochester

    Project Description: This project aims to demonstrate the reliability, validity, and meaningfulness of two key digital measures, daily living mobility (gait) and chorea, captured remotely and continuously using wearable sensors, in early-stage Huntington’s disease (HD), a rare, progressive neurodegenerative disease with no cure. Additionally, this project will explore the reliability and validity of daily physical activity, heart rate variability, and sleep. These measures have the potential to be meaningful endpoints for clinical trial outcomes in HD, but critical gaps first need to be addressed. As genetic and disease-modifying interventions emerge, there is an urgent need for early and accurate assessment of disease-specific motor impairments in HD. Traditional measures are subjective and episodic with a limited ability to capture early, more subtle motor features. Digital measures have the potential to remotely quantify disease-specific impairments. This study will inform larger-scale validation efforts and clinical endpoint studies in HD with the potential to impact other, more common neurological diseases with involuntary movements (e.g., Parkinson’s disease).

  • Improving the Integrity of Novel Digital Health Technology-derived Endpoints through Rigorous Simulation Studies of Multiple Imputation Techniques

    CERSI Program: UCSF Stanford

    Project Description: The goal of this project is to improve understanding of data from wearable devices. To that end, investigators will: (1) develop an open-source tool to help simulate patient data from wearables including non-wear periods using databases from completed clinical trials; (2) create and test strategies for handling non-wear periods; and (3) establish open source code for recommended strategies. Overall, advancement of science will help take data from patient wearables and translate them into evidence that can be used to get better treatments for all patients.

  • Novel DHT-centric statistical methods for subject-level fingerprinting and handling missingness

    CERSI Program: Johns Hopkins

    Project Description: Project investigators propose to develop novel statistical methods to verify that the DHT data has been generated by the same individual based on their physical activity and sleep patterns, and fill in missing data gaps in DHT data by combining tools from time series, functional, and distributional data analyses.

  • Developing a Composite Score with Actigraphy Physical Activity and Heart Rate Measurements as a Sensitive Study Endpoint to Facilitate the Use of Digital Health Technology in Pediatric Clinical Trials and Drug Development

    Awardee: The National Institute of Standards and Technology (NIST)

    Project Description: This project aims to use the power of the scientific computation approach to advance the use of actigraphy endpoints in pediatric pulmonary arterial hypertension (PAH) clinical trials. We plan to achieve three primary objectives: (1) Develop a composite score with actigraphy physical activity and heart rate measurements; (2) Examine the use of the composite score in children with PAH to assess disease severity and detect disease progression; (3) Introduce a framework to expand the use of actigraphy to a broader digital health technology space and other pediatric diseases. The goal is to use actigraphy data in a measured way to address the unmet need in pediatric PAH and other pediatric rare diseases.

  • Developing an Objective and Quantitative Endpoint for Atopic Dermatitis in Pediatric and Adult Populations

    Awardee: Emerald Innovations, Inc.

    Project Description: The goal of this project is to develop an objective, quantitative, and user-friendly digital endpoint to assess nocturnal scratching in children with atopic dermatitis. This endpoint will fulfill a crucial unmet need by for assessing the efficacy and performance of FDA-regulated products for atopic dermatitis and pruritus. Currently, these assessments heavily rely on subjective self-reported endpoints like the NRS (Numeric Rating Scale). A machine learning model for assessing nocturnal scratching from radio signals will be developed to draw comparison to healthy controls in terms of scratching and disease burden.

  • Using mHealth to Measure Impact in Functionality Behavior, Activity and Sleep Patterns in Children and Adolescents Treated with Psychotropics

    CERSI Program: University of Maryland

    Project Description: This project aims to leverage the power of mobile technology to address three primary objectives: (1) fill the gap in the capture of behavioral, functional and activity data; (2) ease the burden on patients, caregivers, and providers struggling to capture relevant and actionable data related to treatment and care management; (3) identify severity of behavioral changes after treatment initiation or change, rates of adverse events/secondary effects, along with patterns of medication use and adherence. The ultimate goal is to integrate these data with larger data systems and existing data sources to support changes in labeling or in practice patterns.

  • Evaluation Mobile Health Tool Use for Capturing Patient-Centered Outcome Measures in Heart Failure Patients

    CERSI Program: Yale-Mayo

    Project Description: The goal of this project is to test the feasibility and reliability of capturing quantifiable measures of functional capacity and quality of life (QoL) using a wearable sensor in heart failure (HF) patients for a period of 60 days. Acute Decompensated Heart Failure (ADHF) patients will be recruited post-discharge from the National Heart Centre and National University Hospital in Singapore. Patients will be monitored at home using the Biofourmis' BiovitalsHF™ platform which will capture biosensor data from two wearable devices: Everion® and Apple Watch Series 4. Patients will also use the BiovitalsHF™ smartphone application to capture electronic patient reported outcomes (ePROs) such as medication adherence, symptoms, the Kansas City Cardiomyopathy Questionnaire (KCCQ) responses, and perform the guided mobile-based 2-minute-step-test.

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