Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

Abstract

The promise of transforming digital technologies into treatments is what drives the development of digital therapeutics (DTx), generally known as software applications embedded within accessible technologies—such as smartphones—to treat, manage, or prevent a pathological condition. Whereas DTx solutions that successfully demonstrate effectiveness and safety could drastically improve the life of patients in multiple therapeutic areas, there is a general consensus that generating therapeutic evidence for DTx presents challenges and open questions. We believe there are three main areas where the application of clinical pharmacology principles from the drug development field could benefit DTx development: the characterization of the mechanism of action, the optimization of the intervention, and, finally, its dosing. We reviewed DTx studies to explore how the field is approaching these topics and to better characterize the challenges associated with them. This leads us to emphasize the role that the application of clinical pharmacology principles could play in the development of DTx and to advocate for a development approach that merges such principles from development of traditional therapeutics with important considerations from the highly attractive and fast‐paced world of digital solutions.

Digital Mental Health for Schizophrenia and Other Severe Mental Illnesses: An International Consensus on Current Challenges and Potential Solutions

“…Even engagement itself may require mechanistic research as it has proven to be a challenging construct to improve upon. For example, a recent review of digital therapeutics suggested that the field could benefit from the application of clinical pharmacology principles from the drug development field, such as a stepwise and progressive focus on engagement and adherence, proxy of effects, and clinical end points [ 104 ]. This would need funders to launch specific calls for this type of research (as this is intricate and costly) and is explored further in theme 3 in the following section.…”

Practical application of digital therapeutics in people with mood disorders

“…In WHO's Comprehensive Mental Health Action Plan 2013–2030 it is planned to boost mental health promotion and prevention strategies, as well as to strengthen the mental health information systems as well as digital opportunities in mental disorders [ 1 ]. Indeed, digital psychiatry may offer different prevention, management, and treatment interventions for a broad spectrum of physical, mental, and behavioural conditions [ 2 ]. In the field of mental health, many digitally-delivered interventions have been developed for delivering effective and feasible treatments for several mental conditions, including mood disorders [ 2 ].…”

“…Indeed, digital psychiatry may offer different prevention, management, and treatment interventions for a broad spectrum of physical, mental, and behavioural conditions [ 2 ]. In the field of mental health, many digitally-delivered interventions have been developed for delivering effective and feasible treatments for several mental conditions, including mood disorders [ 2 ]. Indeed, few digital mental health interventions are effectively supported by scientific and clinical evidence, such as the digital therapeutics (DTx).…”

“…DTx uses digital implements such as mobile devices, apps, virtual reality, the Internet of Things (IoT), wearable sensors and so forth to spur patients’ behavioural changes. DTx can be used as a standalone therapy or in combination with pharmacological treatment, integrating software- and algorithm-based technological innovation with drug treatment [ 2 , 3 ]. DTx are classified as Medical Devices and, hence, they need to be specifically developed with high scientific quality and validated standards through randomized controlled clinical trials (RCTs), as for drug-based therapies [ 3 ].…”

Novel Therapeutic Modalities: The Future is Now

“…Ribba et al 26 show how in silico approaches themselves have become novel modalities in their own right. In their review, they make the case that fundamental clinical pharmacology principles can benefit the development of digital therapeutics (generally known as software applications embedded within accessible technologies-such as smartphones-to treat, manage, or prevent a pathological condition) in three areas: characterization of the mechanism of action, optimization of the intervention, and dosing.…”