Letter from the Editor

Contributed by:

Taren Grom, Editor

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

Clinical Data in Real Time

PV0315_TarenGromThe 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


pv01016_theirwordTheir word…

Denise Myshko
Managing Editor

The use of smartphones and wearables in the general population will drive use in clinical research.

Robin Robinson
Senior Editor

TV still reigns as the ad spending king of DTC, but numerous digital channels are being used to personalize consumer messaging.

Kim Ribbink
Features Editor

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

Cancer MoonShot
Combination Therapies
Gene Editing
Health Bots
The Industrial Internet
Precision Medicine
Smart Technology
Talent War
Triple Aim
Virtual Reality
Showcase:  e-Solutions



Volume 16 • Number 9
Publisher    Lisa Banket
Editor    Taren Grom
Creative Director    Marah Walsh

Managing Editor
Denise Myshko

Senior Editor
Robin Robinson

Features Editor
Kim Ribbink

Design Associate
Ariel Medel

Director of Sales
Cathy Tracy

National Account Manager
Suzanne Besse

Webcast Network Producer
Daniel Limbach

Circulation Assistant
Kathy Deiuliis

Copyright 2016
by PharmaLinx LLC, Titusville, NJ
Printed in the U.S.A.
Volume Sixteen, Number Nine

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