Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials

Abstracts

Day 1: Wednesday September 30, 2015

Keynote Address

The Potential of Mobile Biosensor Technology to Revolutionize Clinical Health
Ian Ferguson, ARM

With an estimated 5 billion smart phones now in use in the world, consumers have an incredible amount of computing functionality at their fingertips and, as importantly, access to a wealth of information in the cloud. Wearable devices offer an incredible opportunity to enable a rich range of new healthcare services. That said, the first wave of devices are struggling to reach broad deployment levels. This keynote will attempt to give an audit of the current market and discuss the fundamental items that must be addressed by the industry to enable this technology to realize its potential.
 

Session I: Leveraging Mobile Biosensor Device Technology to Improve Clinical Trial Outcomes and Patient Health

Implementation of Mobile Sensor Device Technology into Clinical Trials
Tomasz Sablinski, MD, PhD, Transparency Life Sciences

Lost in Translation?: A Clinican's Perspective on the Mobile Health Opportunity
John D. Hixson, MD, University of California San Francisco and the San Francisco Veterans Affairs Center, San Francisco, California, United States

The development of sophisticated wearables, biometric sensors, and health-related mobile applications has led many to predict the rapid integration of these technologies into clinical trials and everyday healthcare delivery. Indeed, the potential for these hardware and software products is vast and exciting. However, to successfully achieve this potential, developers and researchers must realize and systematically address a number of practical barriers. The presentation will comment on three critical areas of attention, using specific examples from the presenter's experience in the management of epilepsy. First, mobile health developers must prioritize and demonstrate data accuracy, reliability, and integrity. In many clinical situations, 'medical grade' data is essential, and it may often need to be validated against established 'gold standard' metrics. Second, developers must compare these newly available data sets to the existing outcomes measures used in traditional clinical trials. In some cases, the 'value' of the mobile- or sensor-based data may need to be justified within a more traditional context. Finally, innovators must concurrently experiment with new workflow and economic models for integrating these novel data streams into clinical practice. By recognizing and addressing these needs proactively, the mobile health community stands the best chance of translating the potential into reality.
 

Session II: Commercial Health Applications of Mobile Biosensors and Apps for Expediting Clinical Discovery

The Role of Mobile Technologies in Innovative Healthcare Solutions
John J. Mastrototaro, PhD, Medtronic plc, Los Angeles, California, United States

The healthcare industry is undergoing a major transformation. New models are being established to address three universal healthcare needs, 1) improved patient outcomes, 2) expanded access, and 3) optimized cost and efficiency. The use of mobile technologies may be the key ingredient in addressing each of these healthcare needs. As value-based healthcare becomes the norm, with payment based on outcomes and not services rendered, incentives will be tied more directly to the value delivered. Medical device providers will be held more accountable for achieving positive clinical outcomes, and in order to assure success, they will need to create better solutions with their therapies. Instead of the touch point with patients being solely at the time of a procedure or sale of a medical device, there is a drive toward a more comprehensive partnership with patients, providers, and payers, extending the scope of services and interactions to provide a longitudinal continuum of care. In clinical trials, post-market surveillance, and routine patient management, mobile technologies are being incorporated into novel systems for monitoring and improved therapy delivery. Questions arise as to how and whether health and wellness devices as well as other unregulated products should be incorporated into these platforms. In this presentation, I will discuss the challenges of healthcare today and present some of the innovative solutions to revamp healthcare delivery by leveraging the pervasive use of mobile technologies and digital data.
 

Biometric Analysis of Racecar Drivers and its Application to Drug Discovery and Clinical Trials
Michelle Crouthamel, GlaxoSmithKline R&D, Collegeville, Pennsylvania, United States

The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Fundamentally, the conduct of clinical trial has not changed significantly over the last few decades. Emerging digital and mobile health technologies have the potential to improve the conduct of clinical trials, allowing for more efficient development of new medicines for patients. Seeking patients' input into the design and conduct of clinical trials is now possible via mobile devices, sensors and remote technologies that can enhance recruitment, retention, adherence and clinical endpoint measurement. Data and experiences from a number of clinical trials will be summarized, highlighting the opportunities and challenges in this new area of clinical development.
 

Session III: The Latest in Mobile Biosensor Development and Design for Emerging Clinical and Health Care Applications

Mobile Imaging, Sensing and Medical Diagnostics
Aydogan Ozcan, PhD, UCLA and Howard Hughes Medical Institute (HHMI), Los Angeles, California, United States

In this presentation I will discuss some of the emerging applications and the future opportunities/challenges created by the use of mobile phones and other consumer electronics devices as well as their embedded components for the development of next-generation imaging, sensing, diagnostics and measurement tools through computational photonics techniques. The massive volume of mobile phone users, which has now reached ~7 billion, drives the rapid improvements of the hardware, software and high-end imaging and sensing technologies embedded in our phones, transforming the mobile phone into a cost-effective and yet extremely powerful platform to run e.g., biomedical tests and perform scientific measurements that would normally require advanced laboratory instruments. This rapidly evolving and continuing trend on the use of mobile phones and other emerging consumer electronics devices including e.g., wearable computers, in advanced imaging and sensing experiments might help us transform current practices of medicine, engineering and sciences through democratization of measurement science and empowerment of citizen scientists, educators and researchers in resource limited settings and developing countries.
 

Innovative Design and Development of Mobile Sensor Device Technology
Veena Misra, PhD¹

Health care continues to be one of the biggest challenges facing our society. Factors such as lifestyle choices, genetics, aging, stress and environmental exposures play a critical role in determining health outcomes. Wearable technologies that can enable continuous/long-term personal health monitoring and personal environmental monitoring can empower users to make better lifestyle decisions and improve health outcomes. However, wearable technologies face challenges which limit their effectiveness. These challenges include poor battery life, large form factor, limited sensor functionality, poor configurability and insufficient data/value. The NSF Center for Advanced Self-Powered Systems of Integrated Sensors and Technology (ASSIST) Center is addressing the above challenges by developing wearable systems that are self-powered for continuous/long-term monitoring, have multi-modal sensing to monitor different signals on the body, are comfortable to wear over long periods of time and have the right algorithms and correlation to provide intelligent and actionable information to the health care user and providers. The self-powered operation enables continuous monitoring, which in turn can enable longitudinal health studies and assist in creating a paradigm shift towards data driven medicine. The talk will discuss the recent breakthroughs in these sensor platforms such as human body power harvesting, low-power health sensors (EKG, hydration, pulse-oximetry, biochemical markers such as cortisol and lactates), personal environmental exposure sensors (gasses, volatile organic compounds and particulate matter) and intelligent data algorithms. These integrated components can go much further than simple activity monitoring and provide a significantly more sophisticated understanding of human health through correlation of heterogeneous data streams.
 
Coauthors: Shekhar Bhansali, PhD², Alper Bozkurt, PhD¹, Benton Calhoun, PhD³, Suman Datta, PhD⁴, Jesse Jur, PhD¹, John Lach, PhD³, Omer Oralkan, PhD¹, Mehmet Ozturk, PhD¹, David Peden, MD⁵, Susan Trolier-McKinstry, PhD⁴
1 North Carolina State University, Raleigh, North Carolina, United States
2 Florida International Univeristy, Miami, Florida, United States
3 University of Virginia, Charlottesville, Virginia, United States
4 Pennsylvania State University, State College, Pennsylvania, United States
5 University of North Carolina, Chapel Hill, North Carolina, United States
 

Connected Materials at the Biological Interface
Fiorenzo Omenetto, PhD, Tufts University, Medford, Massachusetts, United States

Biomaterials offer opportunities for devices that operate seamlessly at the interface of the biological and technological worlds. Stringent requirements on material form and function are imposed when operating at the nanoscale or when interfacing such materials with microelectronic circuitry. Among the possible options, silk fibroin is a very attractive biopolymer for these purposes.  Devices such as silk-based photonic crystals, lasers, wireless antennas and resorbable electronics (along with a perspective for their integration) will be described as some examples of the possibilities that this water-processed, biocompatible material offers.
 

Session IV: Managing Mobile Biosensor Generated Data: Analysis, Infrastructure, and Security

The Beginnings of an Open Ecosystem in mHealth
Brian M. Bot, Sage Bionetworks, Seattle, Washington, United States

Mobile technologies have the potential to revolutionize both the way in which individuals monitor their health as well as the way researchers are able to collect frequent, yet sparse data on participants in clinical studies. In order for data from these devices to have maximal impact in a research setting however, the development of systems to collect, manage, and broadly share these data is essential. Possibly more important are the social constructs on which these systems need to be built to allow maximal utility to come from these data while minimizing adverse impact on individual participants. More specifically, the union of these systems and constructs must be an ecosystem build upon trust. We will present one such ecosystem focused on putting the participant at the center of the data collection: specifically by acknowledging possible risks to both individual participants as well as sub-populations of participants, providing opt-in settings for broad data sharing, and the development of an open research ecosystem built upon a social contract between researchers and research participants. A case study of one such mHealth study, leveraging Apple's ResearchKit framework, will be presented and discussed.
 
Coauthors: Andrew Trister, Michael Kellen, John Wilbanks, Stephen Friend, Sage Bionetworks, Seattle, Washington, United States
 

Mobile Health Apps Transforming Medical Research and Clinical Care: Using Apple's New ResearchKit for Asthma Mobile Health Study
Pei Wang, PhD¹

Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease particularly amenable to having a Mobile Health Application (MHA) facilitate active monitoring outside of periodic traditional medical visits. The asthma MHA is designed to facilitate asthma patient education and self-monitoring, promote positive behavioral changes, and reinforce adherence to treatment plans. Our research study will assess the association between the usage of the app and asthma symptom control, quality of life, and health care utilization. To date, the app has been downloaded approximately 50K times and over 8,000 individuals have electronically consented and enrolled in our Asthma Health research study. In the talk, we will describe the launch of the Asthma Mobile Health App as well as preliminary findings and lessons learned to date. We will discuss the infrastructure, data management and data analysis we used. We will also discuss the benefits and limitations in conducting medical research with mobile devices, using Apple's Research Kit and similar platforms as well as the promise of m-Health applications in improving clinical care.
 
Coauthors: Yu-Feng Yvonne Chan, MD, PhD¹, Linda Rogers, MD¹, Nicholas Genes, MD, PhD¹, Steve Hershman, PhD², Stephanie Thomas, MPH¹, Samantha Violante, MPH¹, Micol Zweig, MPH¹, Charles Powell, MD¹, Rosalind Wright, MD¹, Joel Dudley PhD¹, Rafhael Cedeno, BS², Eric Schadt, PhD¹
1 Icahn Medical School at Mount Sinai, New York, New York, United States
2 LifeMap Solutions Inc., San Francisco, California, United States
 

Managing Biometric Big Data: The Promise and Challenges
Pamela C. Baker, FierceBigData, Columbus, Georgia, United States

While the advent of wearables, sensors, smart fabrics, and apps is set to transform both clinical research and patient care, the challenges in analyzing, storing and securing the data they generate and collect continues to vex researchers and providers. In this high-level review of the promise and challenges these technologies present, and steps to take to address each, lies a surprising twist: how these technologies are fueling the restructuring of clinical research. Big data, small data, and tools galore, the real innovation here is in how these technologies are changing the way researchers think and work. This exploration of the possibilities in changing everything from traditional processes and collaborative models, to the new concept of cost-sharing to stretch research budgets will illustrate how to leverage these technologies to the researchers' utmost advantage. Managing biometric data far exceeds the traditional idea of data management. Now it includes strategic plays to stretch budget dollars, win research grants and funding, and get to the end goal and final payoff more efficiently and faster. This high-level overview covers all these possibilities and challenges in the most practical of terms. Attendees will leave the discussion with new ideas they can likely implement immediately or at least in the very near future.
 

Day 2: Thursday October 1, 2015

Keynote Address

The Impact of Wearable Technologies for the Healthcare Market
Christian Stammel, MBA, Wearable Technologies AG, Munich, Germany

The healthcare market is an important industry from both an economic and human wellness perspective. Introduction of medically certified products into the marketplace represents a huge challenge for the companies developing them. Long certification processes can often even lead to outdated products once they enter the market resulting in decreased consumer demand, however, it is also important for medical certification processes to be reliable and effective to ensure patient safety. This is especially important for technologies worn on the body for an extended amount of time, including wearable activity trackers that are commonly used by consumers to monitor vital physiological parameters with the goal of achieving improved overall health. Currently, there are companies innovating medical wearables such as doctor's glasses that make patient's veins more visible, tiny devices to monitor your blood pressure, and headsets that monitor brainwaves and translate them into meaningful data for clinical applications.
 

Session V: Regulation, Compliance, and Standards of Emerging Mobile Biosensor Technologies for Clinical Applications

Regulatory Considerations Regarding the Use of Biosensors in Clinical Trials
Leonard Sacks, MD, Office of Medical Policy, CDER, FDA, Silver Spring, Maryland, United States

Biosensors offer unprecedented opportunities to make unobtrusive physiological measurements, and to transmit data from remote locations. They allow real- time monitoring of responses in clinical trials, and in some situations may allow trials to be conducted from the patient's home. Important considerations in the measurement of physiological or pathological responses include the accuracy and validity of the measurement, the clinical significance of the measurement and the integrity of the record. For drug approval, the measurements should provide substantial evidence of drug efficacy and demonstrate a clinically meaningful benefit to patients. Their validity as trial endpoints is subject to the same considerations as are traditional clinical endpoints or surrogate endpoints.
 
Remote data transmission offers advantages for patient convenience, may reduce loss to follow-up and allows capture of data that was not previously possible. However offsite conduct of trials raises considerations regarding patient privacy, attributability of information and patient safety.
 
Despite the challenges presented by new technologies, the potential opportunities are likely to revolutionize the logistics of clinical trials. These technologies may improve the efficiency of drug development and may allow the study of conditions in ways that were not possible using traditional trial designs.
 

Data Privacy, Cybersecurity and Health IT Legal Issues in Emerging Mobile Health Technologies
Linda A. Malek, JD, Moses and Singer, LLP, New York, New York, United States

The rapid expansion in the field of mobile and personal health technologies has outpaced much of the current regulatory framework. Device manufacturers, app developers, researchers and clinicians have been quick to encourage adoption of wearable biosensor and similar mobile technologies, but these novel uses should consider evolving law and regulatory guidance. The intersection of mobile technology and healthcare in human subject research promises a deeper field of potential subjects and rapid results. Mobile apps that track symptoms, vital signs, and remind participants to take their medicines help provide personalized healthcare in real-time. Yet investigators, clinicians, manufacturers and developers need to take extra steps to ensure that the safety of the subject—and her personal information—continue to be of paramount importance.
 
This panel discussion will examine current and pending regulations, as well as certain gaps in the rules, related to health IT infrastructure, emerging technology, medical data privacy and security, and human subject research. We will discuss which agencies are responsible for regulating both healthcare and technology, such as the FDA, FCC, FTC, and the DOJ. Implications of HIPAA, HITECH, The Common Rule, and the EU Data Privacy Directive on the use of mobile apps and biosensors for clinical and research purposes will be explored as well.
 

Session VI: Societal Impact for the Use of Mobile Biosensor Technologies on Human Health

Societal Impact for the Use of Mobile Biosensor Technologies on Human Health
Bernard Munos, MS, MBA, FasterCures (a center of the Milken Institute), Indianapolis, Indiana, United States

Collecting data to test new therapies is a slow and expensive process that has throttled the speed of innovation and helped drive the price of new drugs to extreme levels. Mobile biosensor technologies promise to radically change that. With their low-cost and ability to capture large volumes of FDA-compliant data on all sorts of biomarkers, they will soon offer scientists behavioral, environmental, social network and outcome data that will help them understand how diseases develop and drugs perform in individual patients. The result will be more effective preventive therapies and a greater ability to design better drugs that interfere precisely with pathological processes while limiting toxicity. It will transform public health, but most importantly will also transform the economics of healthcare. By enhancing the health status of the population and lowering the cost of medicine, it will have a positive material impact on the economy.
 

The Ethics of Wearables: Challenges and Opportunities for Citizen Science
David C. Magnus, PhD, Stanford Center for Biomedical Ethics, Stanford, California, United States

The emergence of wearable technology and mobile health to vastly increase participation in research also presents opportunities for far more interactive approaches to research and clinical trials. Greater participation by and empowerment of citizen scientists challenges traditional approaches to regulation and ethics. How should we interpret the various roles that will soon be played by those living "quantified" lives?