Prescription Digital Therapeutics (DTx), Digital Health Tools, & Decentralized Clinical Trials: How They Interact

Over the past few years, the healthcare and clinical trials space has seen unrivaled advancements through digital technologies offering a new patient-centric care delivery system; A system capable of extending clinician reach, overcoming geographic constraints, and catering to specific patient needs. Digital therapeutics (DTx) are a key component to modernizing care through clinically validated platforms dedicated to the advancement of healthcare through improved accessibility and patient care tactics.

What are digital therapeutics (DTx)? 

The Digital Therapeutics Alliance (DTA), an association made up of industry leaders committed to the advancement of digital therapeutics, holistically defines digital therapeutics (DTx) as “deliver[ing] evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease.” So, what is a digital therapeutic? In other words, digital therapeutics, or DTx therapeutics, refers to interventions, care instructions, or treatments delivered from providers to patients within a virtual setting. 

Digital therapeutics tools are capable of replacing non-essential in-person interactions between patients and care providers which evidently was an ideal solution for patient monitoring during the COVID-19 pandemic. However, technology such as a digital therapeutics platform and other DTxproducts preexisted the pandemic. COVID expedited the healthcare and digital therapeutics clinical trials industry’s acceptance and adoption of these digital tools, and since 2020, the need for digital therapeutics has increased exponentially. 

What do digital therapeutics do?

Digital therapeutics are software applications that are used as medical treatments. They can be used alone or in combination with other therapies to manage or improve a range of medical conditions, such as chronic diseases, mental health disorders, and behavioral health issues. Some examples of digital therapeutics include:

• Mobile apps that provide cognitive behavioral therapy for mental health conditions
• Virtual reality programs that help with pain management and rehabilitation
• Remote monitoring systems that track vital signs and send alerts to healthcare providers
• Artificial intelligence-powered chatbots that provide support and guidance for patients
• Digital programs that provide personalized care plans and health coaching

It's important to note that digital therapeutics must be backed by clinical evidence and should be used in conjunction with the guidance of a qualified healthcare professional.

What are digital therapeutics examples?

Some examples of digital therapeutics include:

• Mobile apps that provide cognitive behavioral therapy for mental health conditions, such as anxiety and depression.
• Virtual reality programs that help with pain management and rehabilitation after an injury or surgery.
• Remote monitoring systems that track vital signs, such as blood pressure and glucose levels, and send alerts to healthcare providers in case of abnormalities.
• Artificial intelligence-powered chatbots that provide support and guidance for patients with chronic diseases, such as diabetes or heart disease.
• Digital programs that provide personalized care plans and health coaching, such as weight loss and smoking cessation programs.
• Digital prescription therapy for insomnia, ADHD, substance use disorder, and other conditions.
• Digital programs that use biofeedback, such as heart rate variability, breathing, and other physiological measures to provide feedback and guidance on stress management and other behavioral health issues.

What are prescription Digital Therapeutics?

Prescription digital therapeutics simply refers to the care instructions or interventions prescribed to patients electronically through digital care platforms typically developed by specialized prescription digital therapeutics companies with the help of a digital therapeutics CRO testing them in digital therapeutics clinical trials. This allows patients to receive care from their providers virtually without having to travel to a doctor’s office. Prescription digital therapeutics are often used to treat, prevent, or manage specific conditions or diseases such as IBS, high blood pressure, or even surgical recovery. 

What are digital health tools? 

The use of digital health tools allow care providers to assess patients and prescribe a digital therapeutic treatment all within a remote setting. Digital Health tools can refer to any digital device that connects patients and providers. Many health systems today, opt for a comprehensive platform that enables patient data collection like electronic patient-reported outcomes (ePROs), telemedicine appointments, care instructions, patient education, and much more. 

These tools are supporting elements of care with capabilities that seamlessly connect patients and providers allowing virtual care delivery to be frictionless and efficient. This model allows patients to be closely monitored by healthcare professionals collecting specific patient data points to understand how patients' conditions are while allowing patients and care providers to remain in direct contact throughout the care episode. 

Where Digital Therapeutics, Digital Health Tools, and Decentralized Clinical Trials Intersect

Digital health tools are often the means of delivering digital therapeutics to patients. This culmination for digital therapeutics with the right digital health tools can lead to effective and efficient patient care that is not limited by geographic distance. This is especially important in the context of how these therapies are researched through rigorous clinical trials to prove their safety and effectiveness, much like any other prescription drug or biologic. Innovative digital health tools are designed to optimize the delivery of digital therapeutics through intelligent and well-researched channels that promote communication and data collection. Because many prescription digital therapeutics are meant to be used at home in a self-directed manner, it is important that the clinical setting reflect what the eventual labeled intended use will be. The type of study meant to appropriately evaluate these therapies may rely heavily on digital health tools such as telemedicine, ePROs, wearables, and other mobile evaluation techniques. Decentralized Clinical Trials (DCTs) take advantage of these tools to allow patients to participate at home and in real-world settings that may better reflect what the actual use settings would be for these DTx products. By structuring studies with capabilities that collect clinical evidence through digital health tools, we are able to effectively evaluate the safety and efficacy of products much like we do with traditional therapeutics, but in the case of digital therapeutics, the evidence will more strongly support the way these products will be used.

Results from a recent example study  Curebase ran with metaMe, the manufacturer of Regulora, a digital therapeutic for abdominal pain associated with IBS; showcase the nature of the relationship between PDTs, Digital Health Tools, and DCTs. metaMe utilized Curebase’s digital health technology and services as part of a DCT to analyze the investigational product in a randomized controlled trial. Regulora, the prescription digital therapeutic, was administered to patients remotely and all evidence in the study was collected via the Curebase platform leveraging digital health tools such as ePROs. Healthcare professionals were then able to use the Curebase platform to monitor patients throughout the treatment. 

For detailed information on the methods deployed in the metaMe DCT with Curebase, read the full whitepaper here.