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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics

Meelim Kim^1,2,3,4, Kevin Patrick^1,3, Camille Nebeker^1,3,4

¹Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA, United States.

Journal of Medical Internet Research

|March 5, 2024

Summary

A new framework guides the development of digital therapeutics (DTx), offering a structured approach to evidence generation. This framework integrates real-world data throughout the DTx lifecycle for improved health outcomes.

Keywords:

accessible decision decision making decision-based evidence-making development digital therapeutics medication adherence monitoring pharmaceuticals public health real-world data real-world evidence safe testing therapeutics

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Area of Science:

Digital health interventions
Health technology assessment
Evidence-based medicine

Background:

Digital therapeutics (DTx) offer scalable and accessible health solutions.
DTx development is complex, involving multiple interacting components and adaptive algorithms.
Existing frameworks lack comprehensive guidance for DTx evidence production across the full lifecycle.

Purpose of the Study:

To propose a novel framework for generating real-world evidence (RWE) for digital therapeutics (DTx).
To provide a pragmatic, iterative, and milestone-driven approach for DTx development and deployment.
To guide stakeholders in creating and implementing DTx that advance individual and population health.

Main Methods:

Adaptation of a 4-phase behavioral intervention development model.
Integration of real-world data (RWD) throughout the DTx development and usage lifecycle.
Incorporation of adaptations specific to the unique characteristics of DTx.

Main Results:

A comprehensive DTx RWE framework is presented.
The framework ensures fidelity to user needs by incorporating RWD.
It supports evidence generation from initial development through long-term use.

Conclusions:

The proposed DTx RWE framework addresses the need for lifecycle-spanning evidence production.
It is applicable to diverse stakeholders including industry, healthcare, public health, academia, funders, and regulators.
The framework aims to enhance the advancement of individual and population health through DTx.