Digital therapeutics (DTx) is one of the newest subsets of digital health and delivers evidence-based, clinical-grade therapeutic interventions to prevent, manage, or treat a medical disorder or disease. Used alone or with other medications, devices, or therapies, DTx focuses on a range of medical conditions and supports various stages of the traditional health care process. Digital therapeutics can also address unmet patient needs that traditional treatments and therapies do not.  

DTx requires clinical evidence and real-world outcomes to gain regulatory clearance or approval, just like drug and medical device therapies. Once DTx manufacturers determine their path to commercialization, their success depends on implementing an effective data collection strategy to support the particular challenges of DTx studies, including a lack of standardization and a vast amount of data collected from disparate sources. 

This guide explores the DTx clinical trial landscape and offers guidance on a data collection strategy and system solutions for DTx manufacturers.

We will cover topics like:

  1. How do DTx differ from wellness applications?
  2. How are DTx regulated?
  3. What are the differences between DTx trials and drug trials?
  4. What are the challenges of DTx clinical trials?
  5. Data collection technology for a DTx decentralized clinical trial
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