The Digital Therapeutics (DTx) Real World Evidence Framework: An approach for guiding evidence-based DTx design, development, testing, and monitoring

Thursday, August 22, 2024

About the Webinar:

Abstract: Digital therapeutics (DTx) are health software tools designed to prevent, treat, or alleviate a disease, disorder, condition, or injury by delivering interventions. Common goals for DTx include improving medication adherence or use of medical devices, facilitating behavior change such as improving diet, physical activity, or sleep, or improving mental health, such as care for depression, anxiety, or stress. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across the full lifecycle from initial regulatory approval to long-term use. To fill this gap, the DTx Real-World Evidence (RWE) Framework was created by using a pragmatic, iterative, milestone-driven approach for developing DTx. To ensure the highest level ethical DTx use and of fidelity to the needs of patients, the DTx RWE Framework also incorporates real-world data (RWD) across the entire lifecycle of DTx development and use.

Learning Objectives:

By the end of this presentation, attendees will be able to:

1) describe the key decisions that should be made to generate robust real-world evidence throughout the DTx lifecycle;

2) identify how to improve evidence production and sustainable deployment of DTx in real-world contexts; and

3) describe how the RWE may foster more ethical DTx use while enhancing health equity.

About the Presenters:

Dr. Meelim Kim is a postdoctoral scholar at the University of California San Diego affiliated with the Herbert Wertheim School of Public Health and Human Longevity Science. Her research focuses on developing, optimizing, and evaluating digital health interventions. Her background is in clinical psychology (Master’s Degree), and biomedical science (Doctoral Degree). She is a Board Certified Behavioral Analyst who is clinically trained as a behavioral therapist in applied behavioral analysis (ABA). Lastly, she was a health coach at Noom, a digital healthcare company for weight loss programs. This is how she began to apply all of her knowledge and continue to investigate research in digital interventions up to the present. More about Meelim Kim.

Dr. Eric Hekler is Professor & Associate Dean, Community Partnerships, and Director of the T32 Training on Advanced Data Science for the Social and Behavioral Science, in the Herbert Wertheim School of Public Health and Human Longevity Science in the University of California, San Diego (UCSD), the Director of the Center for Wireless & Population Health Systems within the Qualcomm Institute at UCSD, and Director of the Design Specialization within the Design Lab at UCSD. Eric is a transdisciplinary researcher, educator, and practitioner who works at the intersection of public health (primary affiliation), health psychology (original training), design, and control systems engineering. His mission is to advance methods and processes that equitably serve people and practice towards a more vital, just, and resonantly diverse society and planet. He has numerous publications that span the many disciplines he contributes, has active federal and foundation funding – including as an NIH R01-funded PI, has played an integral role in creating new transdisciplinary educational opportunities and programs at UCSD, and is an active public health practitioner in the San Diego region. He is recognized internationally as an expert in applied health science methods and digital health. More about Eric Hekler.