So, My FitBit is Clinical Trial Grade Right? Keith Wenzel Senior Director, Solution Incubator PAREXEL International

Transcription

1 So, My FitBit is Clinical Trial Grade Right? Keith Wenzel Senior Director, Solution Incubator PAREXEL International 1

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 2

3 So, My FitBit is Clinical Trial Grade Right? Yes? No? Maybe? The ubiquity of consumer grade devices and associated, immediate data visualization belies the complexity of wearables use in clinical trials 3

4 Wearables in Clinical Trials Sponsors are actively evaluating the use of sensors for endpoints, to support drug marketing/adherence and/or for payor approval All major pharma now have innovation groups whose focus includes mhealth (patient engagement & retention, wearables/sensors, mobile enablement, leveraging social media) Drivers include supplemental data, less costly trials (fewer site visits and/or less in clinic procedures), more timely data collection There are many sensors today, but not many yet with high value for clinical trials FDA or EU medical device approval does not equate to acceptance of associated data for labeling claims New sensors are coming to market every year and we can expect medical value and data volume to increase substantially in the coming years 4

5 Wearables Segments 5

6 Wearables Market Size Frost & Sullivan estimates that the size of 6 wearables market for clinical trials is $200,000,000

7 Opportunities by Therapeutic Area 7

8 Therapeutic area targets 8

9 Smartphone Sensors to Measure Health Outcomes Source: DIA 2016 Annual Meeting, Byrom 9

10 Example Continuous Glucose Monitoring (CGM) Professional CGM Personal CGM Owned by CLINICIANS INTERMITTENT use BLIND evaluation RETROSPECTIVE data MINIMAL onboard effort Metrics available: Time-in-range Area under-curve % and # Hypo s Estimated A1C Patterns Meal/exercise markers Post meal response Owned by PATIENTS CONTINUOUS use Displays LIVE data & analysis REAL-TIME data COMPREHENSIVE onboarding Source: Medtronic, Inc. 10

11 CGM is already used in diabetes drug development trials Patient type N Drug Endpoint T2 144 Dulaglutide vs Glargine Time in range T2 598 saxagliptin + dapagliflozin AUC, hypoglycaemia T1 68 Albiglutide Glycaemic variability T1 48 Empagliflozin Time in range T1 500 Insulin A1C and time in range T2 30 DPP4 Time in range T1 24 Pramlintide and Insulin Glycaemic variability Source: Medtronic, Inc. 11

12 So, what does the whole system look like? End-to-end sensors components Reporting and Analytics 12

13 It s about the (BIG) data dummy! In clinical trials, there are no experts. Nobody has done it, and if you talk to traditional biostatisticians, they are absolutely paralyzed by fear of having more than five data points per visit, really. Here we're talking about millions. So we have to go to unusual players, not unusual for big data, but unusual for health care. You have to go to people who have been doing it for a good part of the last 20 years and are getting better at that. These are security experts with the Federal Aviation Administration that analyzes hundreds of thousands of data points a second You actually have to target mathematicians, because mathematicians understand big data...you have to get out of health care and certainly out of the clinical trial business to find people who are not scared by billions, really, billions of data points Sponsor Source: CTTI Webinar, April 17, 2017; MCT Mobile Devices: Evidence from Sponsors and Investigators Using Mobile Devices 13

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16 First it was EDC, then it was epro, now its Sensors 16

17 Minimum Components of a Companion App Schedule The subject can select the schedule tile icon to see when measurements are due. Readings Due The notification icon informs the subject of any readings that need to be taken on the current day. Support Selecting this tile icon allows the subject to find information on how each device should be set up and used. Study Information The Study Information tile icon information on the subject s study site. provides 17

18 Wearables / Sensors Readings Due Screen The Readings Due page shows the date selected, each of the devices the subject is allocated to, and when the measurements need to be taken. This will show the subject how many readings should be taken and how many readings they have completed for each device. The subject will see a notification when results have been received as well as if a measurement is still required to be taken. The subject will also be able to see the time of day the measurements should be taken (specific to study protocol). 18

19 So, My FitBit is Clinical Trial Grade Right? End-to-end, secure data transmission infrastructure in place Robust and scalable platform, by orders of magnitude Transformative analytics and persona-based visualization Life Sciences scientific expertise overlay Incubated within clinical research services processes Advanced, end-to-end supply logistics Omni-channel (mobile, web, IoT ) Multi-cloud integration 19

20 So, My FitBit is Clinical Trial Grade Right? Maybe 20

21 Thank You Keith Wenzel Senior Director, Solution Incubator PAREXEL Join the conversation #DIA