Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content
Digital therapeutics (DTx) are software programs that treat a disease or condition.Increasingly, DTx are part of medical care, and in the US healthcare system they are regulated by the FDA as Software as a Medical Device (SaMD).Randomized controlled trials (RCT) remain a key evidence generation step for most DTx.However, developing a unified approa