“In‐House” Data on the Outside—A Mobile Health Approach

Abstract

Mobile health (mHealth) technologies have the potential to capture dense patient data on the background of real‐life behavior. Merck & Co., Inc. (Kenilworth, NJ), in collaboration with Koneksa Health, conducted a phase I clinical trial to validate cardiovascular mHealth technologies for concordance with traditional approaches and to establish sensitivity to detect effects of pharmacological intervention. This two‐part study enrolled 18 healthy male subjects. Part I, a 5‐day study, compared mHealth measures of heart rate (HR) and blood pressure (BP) to those from traditional methods. Hypotheses of similarity, in the clinic and at home, were tested individually for HR, systolic BP, and diastolic BP, at a 2‐sided 0.05 alpha level, with a prespecified criterion for similarity being the percentage differences between the 2 measurements within 15%. Part II, a 7‐day, 3‐period randomized balanced crossover study, evaluated the mHealth technology’s ability to detect effects of bisoprolol and salbutamol. Hypotheses that the changes from baseline in HR were greater in the bisoprolol (reduction in HR) and salbutamol (increase in HR) groups compared with no treatment were tested, at a 1‐sided 0.05 alpha level. Linear mixed‐effects models, Pearson’s correlation coefficients, summary statistics, and exploratory plots were applied to analyze the data. The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol.

Digitally Enabled, Patient‐Centric Clinical Trials: Shifting the Drug Development Paradigm

“…73,75,76 Merck & Co., Inc. (Kenilworth, NJ, USA) also conducted a study in collaboration with Koneksa Health that explored use of mobile health approaches to measure changes in heart rate and blood pressure, which found that mobile health approaches were comparable to standard in-clinic measures and Accepted Article sufficiently sensitive to detect treatment differences, demonstrating potential to capture rich hemodynamic data in early clinical trials to aid decision-making. 77 Digital biomarkers may be particularly useful in disease areas that are hindered by a lack of validated biomarkers to objectively measure disease onset and progression, such as neurodegenerative diseases.…”

“…This article is protected by copyright. All rights reserved There are several platform providers that offer such capabilities 77,91,92 , and we have tested several of these capabilities from various providers and are introducing these approaches into trials dependent on study need.…”

“…Merck & Co., Inc. (Kenilworth, NJ, USA) have previously reported our experiences with implementation of dried blood microsampling in in-clinic and at-home settings 36-39, 47,48 as well as results of Phase 1 studies intended to evaluate technologies of interest. 36,37,77 Such technology evaluation trials are an important piece of enabling adoption of new technologies into the clinical trial paradigm and realizing the vision of patientcentric trials . These types of trials provide the ability to rapidly sift through emerging technologies to identify which are useful for clinical research, enable rapid "learn and confirm" cycles for emerging technologies to become "ready" for use in portfolio-facing pharmaceutical clinical trials, and provide insights into patient preferences and ease of use.…”

“…Other examples of such efforts include smartphone motor‐sensing for detection of early signs of Lyme disease 73,74 and investigation of wearable devices for cardiac monitoring 73,75,76 . Merck also conducted a study in collaboration with Koneksa Health that explored use of mobile health approaches to measure changes in heart rate and blood pressure, which found that mobile health approaches were comparable to standard in‐clinic measures and sufficiently sensitive to detect treatment differences, demonstrating potential to capture rich hemodynamic data in early clinical trials to aid decision making 77 …”

“…Furthermore, we envision that such a platform can be utilized as a tool for delivering digital content to patients (e.g., instructional materials, ePROs, and study‐specific apps), for eConsent, patient reminders (e.g., to take study medication, for study‐related tasks, or for upcoming clinical visits) as a tool to more closely engage with the patient throughout the course of the trial (e.g., through mobile apps, secure messaging, and/or videoconferencing), and for telehealth visits, depending on the needs of the study. There are several platform providers that offer such capabilities, 77,91,92 and we have tested several of these capabilities from various providers and are introducing these approaches into trials dependent on study need.…”