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Activity Number: 77 - Contributed Poster Presentations: Biopharmaceutical Section
Type: Contributed
Date/Time: Monday, August 3, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biopharmaceutical Section
Abstract #312793
Title: Using Digital Data in an Early Phase Clinical Trial to Quantitate Baroreceptor Sensitivity Variability
Author(s): Anwesha Mukherjee* and Geoffrey Walford and Leticia Arrington and Adrienne DiBenedetto and Ruben Declercq and Inge DeLepeleire and Helia Norouzizadeh
Companies: Merck & Co Inc and Merck& Co., Inc and Merck & Co, Inc and Merck & Co., Inc and Merck & Co, Inc and Merck & Co., Inc and Merck & Co., Inc
Keywords: Digital device; Digital data; variablity; spontaneous baroreceptor sensitivity
Abstract:

In today’s rapidly digitizing world it is important to understand the capabilities and limitations of digital devices and how these can be used in clinical settings. Using digital data from a device in clinical trials requires additional time and resource for appropriate planning and pre-work because the device may not provide data in a format that is easy to analyse. A small study may help to quickly understand the application of the digital data, feasibility of its use, and reliability of how it can measure the parameter of interest according to the objective of the study. We have studied to identify a method to monitor spontaneous baroreceptor sensitivity(sBRS) non-invasively using a digital device. Large changes in sBRS from baseline generally raise consideration of impact on cardiac autonomic signaling. In this presentation, we will share the results, especially on variability of sBRS based on data from a small clinical study using the specific device. Based on the findings, this device could be used in future studies for which the method of analysis, pre-clinical data, or clinical findings suggest potential alteration in cardiac autonomic signaling.


Authors who are presenting talks have a * after their name.

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