Prescription digital therapeutics (PDTs) are software programs designed to treat diseases and conditions, either in combination with traditional pharmacotherapy or as standalone treatments. This emerging category of medicine is increasingly becoming an integral part of medical care, undergoing regulation by esteemed health authorities like the FDA and BfArM, classified as Software as a Medical Device (SaMD) and Digital Health Applications (DiGA), respectively. Moreover, private and public payors are diligently evaluating PDTs for coverage. Most of these applications have been applied to mental health combating major depressive disorder, chronic insomnia, panic, and substance use disorders, for example. Beyond their application in symptom management, PDTs are gaining momentum in addressing the underlying neurobiological and physiological drivers of psychiatric disorders through a variety of research avenues. Their development, validation, and distribution draw upon valuable principles from cognitive and behavioral neuroscience, data science, technology, software, and biopharmaceutical industries.
Creating successful PDTs for psychiatric indications requires a unique amalgamation of specialized techniques for product design and technical development, a well-defined therapeutic strategy in their intentional creation, and a diverse range of clinical trial methodologies to validate investigative products and generate robust evidence generalizable among diverse patient populations. Furthermore, seamless implementation systems are essential to ensure PDTs can be effectively prescribed by mental health clinicians, funded by third-party entities, and readily utilized by patients.
In this Research Topic, our objective is to explore and address challenges and solutions in four key domains of PDTs: clinical science (i.e. therapeutic approach, content, validation, and evidence generation), engagement science (i.e. patient motivation and dose-response relationship), regulatory science (i.e. market authorization, safety and tolerability, privacy, and cybersecurity), and implementation science (i.e. distribution across stakeholders including patients, providers, systems of care, policymakers, payors).
Articles published in the Research Topic encompass four overarching domains with a special focus on psychiatric disorders:
? PDT Clinical Science
? PDT Engagement Science
? PDT Regulatory Science
? PDT Implementation Science
In the realm of the burgeoning category of psychiatry, this Research Topic presents a variety of article types including reviews, perspectives, opinions, methodological pieces, and original research. Embracing both hypothesis-generating and hypothesis-confirming studies, this collection of scientific literature aims to shed light on the emerging field of PDTs.
Topic Editor Shaheen Lakhan and Topic Coordinator Brett Colbert are employed by Click Therapeutics. Topic Editor Derek Dykxhoorn declares no competing interests with regards to the Research Topic subject.
Prescription digital therapeutics (PDTs) are software programs designed to treat diseases and conditions, either in combination with traditional pharmacotherapy or as standalone treatments. This emerging category of medicine is increasingly becoming an integral part of medical care, undergoing regulation by esteemed health authorities like the FDA and BfArM, classified as Software as a Medical Device (SaMD) and Digital Health Applications (DiGA), respectively. Moreover, private and public payors are diligently evaluating PDTs for coverage. Most of these applications have been applied to mental health combating major depressive disorder, chronic insomnia, panic, and substance use disorders, for example. Beyond their application in symptom management, PDTs are gaining momentum in addressing the underlying neurobiological and physiological drivers of psychiatric disorders through a variety of research avenues. Their development, validation, and distribution draw upon valuable principles from cognitive and behavioral neuroscience, data science, technology, software, and biopharmaceutical industries.
Creating successful PDTs for psychiatric indications requires a unique amalgamation of specialized techniques for product design and technical development, a well-defined therapeutic strategy in their intentional creation, and a diverse range of clinical trial methodologies to validate investigative products and generate robust evidence generalizable among diverse patient populations. Furthermore, seamless implementation systems are essential to ensure PDTs can be effectively prescribed by mental health clinicians, funded by third-party entities, and readily utilized by patients.
In this Research Topic, our objective is to explore and address challenges and solutions in four key domains of PDTs: clinical science (i.e. therapeutic approach, content, validation, and evidence generation), engagement science (i.e. patient motivation and dose-response relationship), regulatory science (i.e. market authorization, safety and tolerability, privacy, and cybersecurity), and implementation science (i.e. distribution across stakeholders including patients, providers, systems of care, policymakers, payors).
Articles published in the Research Topic encompass four overarching domains with a special focus on psychiatric disorders:
? PDT Clinical Science
? PDT Engagement Science
? PDT Regulatory Science
? PDT Implementation Science
In the realm of the burgeoning category of psychiatry, this Research Topic presents a variety of article types including reviews, perspectives, opinions, methodological pieces, and original research. Embracing both hypothesis-generating and hypothesis-confirming studies, this collection of scientific literature aims to shed light on the emerging field of PDTs.
Topic Editor Shaheen Lakhan and Topic Coordinator Brett Colbert are employed by Click Therapeutics. Topic Editor Derek Dykxhoorn declares no competing interests with regards to the Research Topic subject.
