Transcript S1-2_Ho-Joong Kim_Mobile and Wearable Devices in Clinical

Mobile and wearable
device in Clinical Trials
Hojoong Kim
Korea
Samsung Medical Center
Mobile devices
The dose of digital website lists more than 300 pharma mobile health apps.
Healthcare Mobile Apps
More than 4000 apps are available within the Apple App Store aimed at patient endusers.
Mobile ownership
Almost all population below 60 are owning mobile device.
Wearable devices
More than 200 wearable devices are available at 2009.
Healthcare Wearables Sold
Wearable devices by body location
Global distribution of wearable devices
Wearables in Clinical Trials
Wearable devices in Clinical Trials
Google Wristband
For pulse, heart rhythm, skin temperature, light exposure, and noise levels
Biostamp by MC10
a patch-like device with built-in sensors, measuring the size of a band-aid that can stick to human skin
and relay data of blood pressure, temperature, pulse rate, oxygen saturation, etc.
Apple ResearchKit App
Apps to manage data collected via wearable devices and smartphones in Medical
Research.
ePRO (Electronic Patient Reported Outcome)
by PAREXEL
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more than two million patient assessments worldwide
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to capture patient self-reported data ranging from simple diaries to validated
instruments such as health-related quality of life (HRQL) questionnaires to complex
clinical assessments such as depression evaluation.
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ePRO methods
1) IVR (Interactive Voice Response): using the subject’s own telephone
2) web
What is mobile health?
Any patient health information accessed using mobile technology, such as a
smart phone, tablet, or other wireless device.
These health applications provide diagnostic and treatment support, remote
monitoring, data collection, awareness, wellness, training/education, and
tracking.
Example 1) 13-year-old boy checking his allergy app to see the pollen count
Example 2) 83-year-old mother receiving ECGs from her home care nurse
with a mobile device that records data and is sent back to her physician’s
office
Why is mHealth important?
According to Pew Research Center, 62% of smartphone owners have used their
phone in the last year to look up information about a health condition.
The global mobile health market to reach 23 billion by 2017 with monitoring,
diagnosis, and treatment-related programs to comprise over half of the market
within the next four years.
How can CTs leverage mHealth?
Provide patients with access to studies they would not otherwise know about
Reduce site visits by wireless data tracking via devices such as Smart Toilets and
ECG’s administered by home health nurses
Allow investigative site staff access to several different formats of study
materials and tools
Offer site and patient education/administration training in different iterations
Personalize patient retention activities such as
Email and SMS: Vvisit, medication and diary reminders
Online patient surveys and assessments
Wearables
Gamification and online community access
How wearable devices benefit CT?
Wearables cut costs, improve data
The healthcare market is regularly teeming with new medications claiming to
be the best treatment for one condition or another. However, how can one be
sure of those assertions before these drugs hit the shelves?
"Wearables could detect issues early on to prevent extra costs or health
concerns."
Problems need to be fixed
Researchers will also need to determine an action plan that accounts for the
non-controlled settings in which patients would be wearing the devices. There
are also various types on the market, which create an inconsistency in the data
collected. Because people behave differently in their daily lives and use myriad
wearables, the information wouldn't be the same across the board,
PharmaVOICE explained.
Standards would need to be created to help with the use and monitoring of
the devices. Researchers would need to determine how to balance the quantity
and quality of data received.
"Planning for variability will require pre-determining the context within which
data will be evaluated to determine what variability is acceptable, and what will
be required in trial design to drive to the right degrees of statistical power and
significance," Thaddeus Wolfram, senior manager of life sciences advisory
practice at EY, told the source.
The eCAALYX example
Mobile devices
Left: Main screen of the eCAALYX Mobile Application;
Right: Visualisation of the heart rate measurement.
The eCAALYX system
Architecture of the eCAALYX
eCAALYX Consortium
eCAALYX interface
FDA Guidance
Definitions
A. Mobile Platform
For purposes of this guidance, “mobile platforms” are defined as commercial off-theshelf (COTS) computing platforms, with or without wireless connectivity, that are
handheld in nature. Examples of these mobile platforms include mobile computers such
as smart phones, tablet computers, or other portable computers.
B. Mobile Application (Mobile App)
For purposes of this guidance, a mobile application or “mobile app” is defined as a
software application that can be executed (run) on a mobile platform (i.e., a handheld
commercial off-the-shelf computing platform, with or without wireless connectivity), or
a web-based software application that is tailored to a mobile platform but is executed
on a server.
C. Mobile Medical Application (Mobile Medical App)
For purposes of this guidance, a “mobile medical app” is a mobile app that meets the
definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act); and either is intended:
to be used as an accessory to a regulated medical device; or
to transform a mobile platform into a regulated medical device.
Examples, NOT medical devices
1. Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books,
audio books) of medical textbooks or other reference materials, medical dictionaries,
articles
2. Mobile apps that are intended for health care providers to use as educational tools for
medical training (e.g., medical flash cards with medical images, pictures, graphs, quiz)
3. Mobile apps that are intended for general patient education and facilitate patient
access to commonly used reference information.
o Interactive diagrams, useful links and help guide
o Provide information about gluten-free food products or restaurants;
o Help match patients with potentially appropriate clinical trials and facilitate
communication between the patient and clinical trial investigators;
o Provide tutorials or training videos on how to administer first-aid or CPR;
o Find the closest medical facilities and doctors to the user’s location;
o Provide lists of emergency hotlines and physician/nurse advice lines;
o Provide and compare costs of drugs and medical products at pharmacies in the
user’s
location.
4. Mobile apps that automate general office operations in a health care setting and are
not
intended for use in the diagnosis of disease or other conditions,
5. Mobile apps that are generic aids or general purpose products.
o Magnifying glass (but are not specifically intended for medical purposes
o Recording audio, note-taking, replaying audio with amplification
Examples of mobile app - FDA’s oversight
Mobile apps that use a sensor or lead that is connected to a mobile platform to measure
and display the electrical signal produced by the heart (electrocardiograph or ECG).
Mobile apps that use a sensor or electrode attached to the mobile platform or tools within
the mobile platform itself (e.g., microphone and speaker) to electronically amplify and
“project sounds associated with the heart, arteries and veins and other internal organs” (i.e.,
an electronic stethoscope).
Mobile apps that use a sensor or electrode attached to the mobile platform or tools within
the mobile platform itself (e.g., accelerometer) to measure physiological parameters during
cardiopulmonary resuscitation (CPR) and give feedback about the quality of CPR being
delivered.
Mobile apps that use a sensor attached to the mobile platform or tools within the mobile
platform itself to record, view, or analyze eye movements for use in the diagnosis of
balance disorders (i.e., nystagmograph).
Examples of current regulations
862.1345 Glucose test system
862.2100 Calculator/data processing module for clinical use
868.1850 Monitoring spirometer
868.1920 Esophageal stethoscope with electrical
868.2375 Breathing Frequency Monitor
868.2377 Apnea Monitor
870.1025 Arrhythmia detector and alarm
870.1110 Blood-Pressure Computer
870.1130 Noninvasive blood pressure measurement system
System
870.1875(b) Stethoscope, Lung Sound Monitor
870.2300 Cardiac Monitor (including cardiotachometer and rate alarm)
870.2340 Electrocardiograph monitor, ST Segment
870.2700 Oximeter
Thank you for attention
Thank you