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Activity Number:
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343
- Longitudinal Analysis, Clinical Trial Design, and Other Topics in Biopharmaceutical Statistics
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313769
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Title:
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A Statistical Evaluation of Agreement Between Mobile Health Technology and Traditional Tools
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Author(s):
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Qinlei Huang* and Radha Railkar
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Companies:
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Merck & Co., Inc and Merck & Co., Inc.
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Keywords:
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agreement;
correlation coefficient;
linear mixed-effects model
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Abstract:
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The future of clinical trials is moving from “site-centric” towards “patient-centric”. 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 monitoring outside of the CRU. This presentation will present the statistical methods applied to support a Phase I clinical trial to validate mHealth technologies for concordance with traditional approaches and to establish sensitivity to detect effects of pharmacological intervention. Specifically, we will present the statistical methods applied 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 method of correlation coefficient for repeated measures (CCRM) based on linear mixed-effects model will be specifically reviewed. The sources of disagreement, including inaccuracy, imprecision caused by between-subject variance, within-subject variance, will be quantified and discussed. Real-world data examples and simulations will be included for illustration.
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Authors who are presenting talks have a * after their name.
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