ABSTRACT
This chapter considers one attribute, the scientific evidence and clinical validation that demonstrate the claims of effectiveness and safety made by any digital therapeutic. It explores what claims can be generated from different types of research evidence and clinical validation. Most digital therapeutic products start making a claim for their software or device related to its intended purpose and use. The innovation capability that DTx products offer calls for an assortment of research designs and methods, each acknowledging their respective strengths and weaknesses regarding any claims they may seek to support. All good research and evaluations will endeavor to be as specific as possible in describing key elements, including the setting, the participants included, the intervention used, the comparator used, the measures employed to examine outcomes, and a suitable data analytic strategy. Eligibility criteria for this type of research are kept broad as the priority is to test with some representative users.
