Taren Grom, Editor
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Clinical Data in Real Time
The number of clinical trials using mobile apps more than doubled, rising from 135 in 2014 to 300 in 2015, according to the IMS Health Study Patient Options Expand as Mobile Healthcare Apps Address Wellness and Chronic Disease Treatment Needs. No doubt when 2016 numbers are crunched, we will see another significant increase in the number of trials that are incorporating some type of mHealth technology as part of the protocol. In fact, as of Aug. 29, 2016, a search of clinicaltrials.gov showed 272 studies that mention use of mHealth and 186 studies mention a wearable. These studies range from a study of cancer care coordination in chemotherapy patients to the impact of mHealth in transplant management to a wearable to promote teenagers’ physical activity.
This month’s cover story — mHealth and Clinical Data — explores the potential that sensors, wearable devices, and mobile apps will offer pharmaceutical sponsors in respect to patient data that complement existing data and provide a more complete view of safety and ef=ficacy. In a recent SCORR Marketing report, 50% of industry experts surveyed say they use mHealth technology in their clinical trials and protocols, and of those, 60% consider mHealth very or extremely important to their research.
One advantage of using a wearable technology as a research tool is the ability to do continuous monitoring without the subject needing to keep a daily diary. This is particularly effective for chronic diseases, such as diabetes, where glucose monitoring can be done continuously.
Medidata, just little more than a year ago, completed its MOVE-2014 behavioral study to test whether mHealth devices and tools could be used to drive better health outcomes in overweight adults with type 2 diabetes. MOVE-2014 study participants exhibited high compliance with charging and using the mobile devices, which included wearable activity trackers and smartphones. The study also showed that quantifiable, objective data — i.e., movement levels and sleep patterns — from the activity trackers and subjective, patient-reported diary data collected via smartphones could be securely pulled into the Medidata Clinical Cloud platform and seamlessly integrated with other clinical trial information in a regulatory-compliant manner. Additionally, in assessing the feasibility of using a consumer-grade wearable device to monitor activity among people with type 2 diabetes in a real-world setting, MOVE-2014 demonstrated that continuous feedback on exercise and diet regimens could impact patient behavior and, ultimately, health outcomes; more than half of the study participants lost weight.
One of the challenges that the industry faces is on a regulatory front. As UBC reported, the FDA will most likely be overwhelmed with all the wearables data to review. It is important that developers and the life-science companies that they partner with for pilots develop tools that will truly impact clinical judgment.
As our experts note, the opportunities are great and mHealth technologies will transform the future of the industry.
Taren Grom, Editor
The use of smartphones and wearables in the general population will drive use in clinical research.
TV still reigns as the ad spending king of DTC, but numerous digital channels are being used to personalize consumer messaging.
Attention in the French pharma market is turning to generics, M&A, and the search for breakthrough R&D.
Coming in Nov/Dec 2016 Year in Preview
The Industrial Internet
Volume 16 • Number 9
Publisher Lisa Banket
Editor Taren Grom
Creative Director Marah Walsh
Director of Sales
National Account Manager
Webcast Network Producer
by PharmaLinx LLC, Titusville, NJ
Printed in the U.S.A.
Volume Sixteen, Number Nine
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