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Abstract:
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Digital endpoints can be used based on data through various sources, such as apps, sensors, and wearables such as smart watches, for example, under the bring your own device model. Digital therapeutics may be evaluated through randomized controlled trials (RCTs), pragmatic clinical trials (PCTs), or real-world data (RWD). The corresponding endpoints may be collected continuous in routine daily living and real-time activities, rather than settings such as doctors’ offices or hospitals. Digital endpoints (DTx) may be useful for remote patient monitoring and continuous tracking of patient responses and wellbeing through digitalization of patient diaries, electronic patient-reported outcomes (ePROs), mobility, medication use, and activities to generate real-world evidence (RWE) beyond RCTs. Therefore, they are useful in medical research via de-centralizing RCTs. This presentation aims to: review the uses of digital endpoints and digital therapeutics in various types of studies; examine how cutting-edge digital innovation can potentially improve medication adherence; share some best practices by study type, RCTs, PCTs or RWD, for evidence-generation; discuss advantages and limitations.
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