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Abstract:
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A growing number of clinical trials are using mobile devices to measure the safety and efficacy of new drugs. This presentation will provide an overview of wearable biosensor technology and describe the type and structure of the data that can be collected. In addition, two important statistical topics will be addressed: sample size reduction and measurement validation. First, we will present a model to explain how much the sample size can be reduced by making use of continuously measured patient data. Next, we will show how wearable device measurements can be validated in a small study by comparing against traditional in-clinic measurements. Based on this comparison, we will predict how a large scale study with wearable devices would perform relative to a trial with traditional in-clinic measurements.
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