1. The emerging role of wearable devices for real-world data collection: Engagement or Activation?
October 18, 2016
Thom Schoenwaelder Vice President, PAREXEL Access, PAREXEL International

2. Today’s exploration Agenda
How will RWD (real world data) be affected by the growth of wearables, biosensors, smart devices and apps?
How will the use of RWD change utilization of Real World Evidence for access evaluation, and clinical development?
Can access to this data change the use of information to engaging stakeholders and activate them to take action at the sub- population and broader level?
Is this new trove of information able to change the threshold for evidence for access decisions and will it impact the definition of value moving forward?  

3. Definitions for today’s discussion
For the sake of this discussion, Real World Data (RWD) will be defined as:
Any patient generated data that is used for decision-making, collected outside of a randomized clinical trial
Real World Evidence (RWE) :
Relevant facts or data that has been analyzed using clinical, scientific and/or commercial rigor used in support of a conclusion or decision

4. What do we mean by “Wearables”?
Wearables are devices worn, applied, or ingested that are designed to measure or capture health-related data in digital format without intervention by the subject and their associated apps. Examples include:
Ingestible Sensors
Smart Contact Lenses
Biometric Watches
Body-Worn Sensors
Mobile Analytics Tools
Wi-Fi Skin
Sensors
Info Source and Image Inspiration: Google; Samsung, Polar, MC10, Proteus Digital Health, CBS News, John Rogers

5. As wearables evolve generationally, more sophisticated data will become available
With each successive generation of wearable technology the data collected is also becoming more clinically relevant, including:
ECG
Heart Rate
Blood Flow
Temperature
CO2 and O2 levels
Simulated Blood Pressure
Real-time ECG
Activity Tracker
Wi-Fi & Bluetooth
(It also tells the time)

6. Approximately between 4. 4 and 7
Approximately between 4.4 and 7.5% of all mobile apps are health related
Source: Statista.com, used with permission

7. The use of health apps has more than doubled in the last two years

8. Reach of Mobile Apps
Mobile Health Apps have a 35% Market reach in the Mobile app market
The estimated number of mobile devices in the U.S. is approximately 4.43 billion in according to Statista
Based on current estimated numbers this represents over 1.5 billion devices in the U.S. alone with some ability to collect health or fitness information, making the data collection potential enormous
Source: Statista.com, used with permission

9. Changing the view of real
world data

10. The Promise…
Vast amounts of objective patient generated data creating innumerable benefits and deep insights.…
The hope is:
No patient interference in data collection
Data collection up to 24/7/365
Broad-based, persistent longitudinal data
Population based metrics resulting in actionable insights
Identification of clinical endpoints based on data that could result in better outcomes
Discovery of digital “flags” to uncover areas in need of further study
To utilizing the data to prove product differentiation in a meaningful way
Based on current state, there is a realization that the promise in unable to live up to the practice

11. In practice (for now)… All data are inherently flawed!...
The reality is:
Policies will need to be created to deal with this influx of data and the myriad issues it creates.
HIPAA: Digital health companies are not bound by HIPAA, since the patient data is not connected to a protected “covered entity”, therefore digital health companies may use the data as they see fit
No data collection guidelines or standards; data transparency
Meager to non-existent quality control
Data integrity
No unified, integrated data aggregation or validation
Little to no interoperability of devices or data sets
real world data can serve to complement clinical trials, but will never replace them

12. Providers Patients Real World Data Policymakers Manufacturers Payers
Data stakeholders
Policymakers
Manufacturers
Payers
Real World Data
Patients
Providers

13. All stakeholders may benefit from access to Real world data
Payer: Provides evidence that a product will perform as expected in their populations; Enable clearer differentiation of products within a specific class; can provide like-to-like comparative evaluations of products to make coverage and reimbursement decisions Providers: Can gain a more well informed view of a product’s efficacy in a broader patient population or sub-population and can see results in patients that may have been otherwise excluded from a RCT Manufacturers: Will have the ability monitor the performance and safety of their products that could lead to patent extensions or new indications Policymakers: Will be able to combine RWD with other clinical and economic data to make prudent healthcare spending decisions Patients: Receive access to more effective treatments, more confidence that their treatment will perform as expected, with better outcomes

14. The issues are significant, however not insurmountable
As the ubiquity and access to these increasingly relevant data becomes more widespread, the issues will have to be addressed by regulatory bodies in order for promise to meet practice:
Questions around the adequacy of HIPAA are being discussed in light of the increasing volume of unregulated personal health data collected by digital health companies
Deciding which data mining tools can be validated and used being used to uncover clinically rigorous and valuable insights
Creation of accepted standards being developed around data transparency and integrity
Establishment of regulatory guidelines allowing wearable RWD submission to be evaluated alongside other clinical data

15. A Global perspective on
Real World Data

16. Regulatory View of Data evaluation (U.S.)
COST-EFFECTIVENESS ANALYSIS
REAL WORLD EVIDENCE
OBSERVATIONAL STUDIES
RANDOMIZED CLINICAL TRIALS

17. Health Technology Assessment View of data evaluation (ex-U.S.)
REAL WORLD EVIDENCE
OBSERVATIONAL STUDIES
COST-EFFECTIVENESS ANALYSIS
RANDOMIZED CLINICAL TRIALS

18. In conclusion

19. Real world data has significant potential, however there is more work to be done
“We hope that there is patient- generated evidence that can be journal worthy and even find its way into regulatory submissions for new products“…
...“If we can get that trifecta of patient-generated data, outcomes data and medical records all in the mix, we'll have a really amazing real-world evidence base to use for all kinds of decisions.” Jeremy Gilbert, Vice President, PatientsLikeMe
Source: ABBVIE Newsroom, Real-World Data Rounds Out Value Picture of Drugs; Jun 08, 2016

20. Questions?