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 end-users.

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 more than two million patient assessments worldwide 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. 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-the-shelf (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 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 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) 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

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