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Abstract:
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The future of clinical trials is moving from "site-centric" towards "patient-centric". Being able to introduce wearable devices that can be used by the trial participants in their daily life will not only make trials less cumbersome, it also offers the opportunity of being able to record data outside of the very controlled conditions in the CRU. The technology revolution and mobile health boom and its potential implementation in clinical trials may result in being able to collect real-world data and perform continuous safety monitoring outside of the CRU; reduce the number of clinical visits; and increase subject involvement, retention and compliance. We will present the statistical methods to evaluate the agreement between mobile health technology and traditional tools including descriptive tools, unscaled and scaled agreement indices, in the setting of a clinical trial with repeated measurements. The sources of disagreement, including inaccuracy, imprecision caused by between-subject variances, within-subject variances, correlation between different methods, will be quantified and discussed. A simulation study will be performed to further assess the performance of these methods.
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