NEW YORK, Jan. 24, 2020 /PRNewswire/ -- Koneksa Health, the leader in developing and implementing patient-focused digital biomarkers for drug development, along with Merck & Co, Inc. (NYSE: MRK) announced the publication of a peer-reviewed Phase I clinical trial evaluating the accuracy and sensitivity of mobile health (mHealth) technologies to measure heart rate and blood pressure.
The study publication, titled "'In-House' Data on the Outside - A Mobile Health Approach," appeared online on Jan. 19, 2020 in Clinical Pharmacology & Therapeutics, the journal of the American Society for Clinical Pharmacology and Therapeutics.
"The study results provide a testimonial that implementing mobile technologies in clinical trials is feasible. Mobile Measurements are comparable with conventional methods, and mobile technologies can detect the effect of a therapeutic intervention," said Elena Izmailova, Ph.D., Chief Scientific Officer at Koneksa Health and one of the authors of the presentation. "Additionally, the patient satisfaction survey conducted at the closure of the study indicated that many of study participants preferred at-home data collection to in-clinic visits, citing convenience and ease to use."
The study, which enrolled 18 healthy male subjects, tested the ability of the mHealth technologies in two parts. Part 1 compared mHealth measures of heart rate and blood pressure with traditional methods. Part 2 evaluated the ability of the mHealth technologies to detect effects of a beta-blocker, bisoprolol, and a bronchodilator, salbutamol. Both parts found the mHealth technologies to be similarly sensitive and accurate compared to traditional methods.
"We are thrilled with the outcome of as it further validates the utility of mobile technologies in clinical trials," said Matt Cantor, Vice President at Koneksa Health and one of the authors of the presentation. "Not only is using mHealth in trials is preferable to patients, it provides more information to researchers faster."
Koneksa Health is a private company that enables the biopharmaceutical industry to develop new medicines with fewer patients. By unlocking the potential of real-world data from remote, wearable, and other digital technologies, Koneksa speeds up the time required to understand how a drug is working and helps to develop real-world evidence for how medicines can impact the daily lives of patients.