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

Abstract

Digital Therapeutics (DTx) are increasingly seen as a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. Developing DTx is inherently complex in that DTx may include multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs. As recommended in a recent worldwide review of regulatory approaches for DTx, a way to address this complexity is to base the design, development, testing, and iterative improvements of DTx on real-world evidence (RWE). Notably, that review highlights the need for improved guidance on when and how to use RWE for DTx. In this paper, we propose the DTx RWE Framework to provide a pragmatic, iterative, milestone-driven approach for producing RWE for DTx regulation. The DTx RWE Framework is based on best practices from human-centered design, optimization trials for behavioral interventions, behavioral health research, and implementation science. It maps these onto the traditional four phase development model for pharmaceuticals but includes key adaptations relevant to RWE production for DTx, such as including early and ongoing partnerships between developers of DTx and their intended users in clinical and/or community settings. Adoption of our DTx RWE Framework may help address known problems with current DTx, including questionable marketing claims, lack of evidence-based guidance for patients, providers, and health care leaders and the need to improve economic incentives that advance the adoption and use of DTx.

Characteristics and Potential Challenges of Digital-Based Interventions for Children and Young People: Scoping Review

“…Although this is a critical point for scalability and implementation of digital interventions, most studies had a limited ethnicity or sex distribution in their recruitment [ 11 , 17 , 18 , 23 , 27 , 31 ] and settings [ 19 , 26 ]. To overcome these barriers, clinical trials should be conducted iteratively based on the DTx Real World Evidence Framework [ 54 ] , highlighting partnership development as a co-design process and using diverse research methods. Similarly, when implementing interventions, language differences should be considered [ 22 ].…”

Therapies go digital. What drives physicians’ acceptance?

“…The Technology Acceptance Model (TAM) remains an extraordinarily relevant and applied theory for evaluating the choice to use technology by considering the most rational factors underlying the adoption process [28,29]. However, although the TAM and its extensions have been applied to analyze physicians' acceptance of digital health technologies (e.g., telemedicine [30] and electronic medical records [31]), further elements should be considered when dealing with disruptive technologies like DTx to understand the users' intention to use them fully [32,33]. In the realm of organizational decision-making, an alternative viewpoint challenges the conventional idea that decisions are solely driven by rational evaluations aimed at optimizing efficiency and effectiveness, highlighting the necessity of considering irrational elements arising from the complex dynamics within the organizational environment [34].…”