Use of Wearable Devices in Clinical Trials

Why Should You Attend:

It may appear that the application of wearable devices to a clinical trial is simply a matter of buying a lot of consumer devices, giving them to the subjects, and incorporating the readings into your study data. Unfortunately, this approach is unlikely to provide the quality data needed to support critically important decisions in drug development.

For example:

• How do you know all of the devices are behaving the same?
• How do you know each device is functioning the same as the battery wears down?
• Will your subjects really wear the devices?
• Do you know how the endpoints (e.g. sleep time, steps/day) are calculated?
• Are the algorithms in the device validated for your patient population?
• Will the sites know what to do if a device fails?
• Will you be able to explain to regulators how the data was obtained?
• Will you be sure the data are CFR 21Part11 compliant?
• Do you know how to prevent your data from going out of date as the technology changes?
• Are you sure that the value of the data is worth the cost?

The application of wearable devices to clinical trials has great potential for improving and lowering the cost of drug development. However, the devices are technically complex, the field is flooded with consumer devices, the conversion of the data to useful endpoints is an area that is not fully developed, and the regulatory environment is still evolving.

This webinar describes the capabilities and limitations of wearable devices for collecting real time data in clinical trials. It presents regulatory issues and provides guidelines for the optimal use of these devices in clinical trials.

Areas Covered in the Webinar:

• What is a wearable device?
• The “nuts and bolts” of wearable devices and clinical endpoints
• How wearable devices can change clinical trials
• How do we get from here to there?
• Better sensors
• Better algorithms
• Better data security
• Establishment of measurement standards
• Resolution of ethical/legal issues
• Current regulatory environment
• How to maximize the benefits of wearables in clinical trials

Who Will Benefit:

• Lead clinicians designing clinical trials in all therapeutic areas
• Technology personnel supporting clinical trial development in pharma
• Contract Research Organizations meeting the needs of Pharma customers
• Statisticians who will be dealing with data from wearable devices
• Clinical trial support personnel in pharma companies
• Clinical Research Associates (CRAs) at sites using wearable devices
• Manufactures of wearable devices interested in getting into the clinical trial space
• Science reporters wanting to understand the basics and potential of wearable devices

Barry Peterson
Independent Consultant, BTPeterson Consulting

Dr. Barry Peterson is now an independent consultant advising pharma and technology companies on the development of wearable device technology and their use in clinical trials. His expertise in this area comes from a career that includes academic research, technology development, drug development and regulatory issues.

Barry is currently a member of the Mobile Technologies group for CTTI (Clinical Trials Transformation Initiative) sponsored by Duke University and the FDA. This group has developed specific recommendations to the FDA on how to review data from clinical trials that incorporate wearable devices (July 2018). He began working with CTTI in 2016 while employed as Sr. Manager of Clinical Affairs at Philips Respironics (Aug 2011-Dec 2017). While at Philips he advised pharma customers on the use of wearable devices in drug trials and developed, published, and patented novel algorithms for analyzing motion data.

His focus on wearable devices began when he served as Director in Clinical Technology at Pfizer (Dec 1999-Aug 2011). During that time, he also developed and published on imaging technologies related to COPD, and liver disease.

Before joining Pfizer, Barry was Professor of Physiology at the University of Texas Health Center at Tyler (Aug 1984-Dec 1999) where he published dozens of papers on the pathophysiology of acute lung injury and the technologies used to investigate lung function. He worked in the same field during his tenure as Assistant Professor of Medicine at the University of Rochester (July 1980-July 1984).

Dr. Peterson holds a BS and MS and Physics and an MS and PhD in Biophysics. His postdoctoral work in lung disease was at the University of Rochester (1977-1978) and Vanderbilt University (1978-1980). Barry is currently on the external review committee of Vanderbilt''s Biomedical Engineering program. At the University of Texas, he served as chair of the policy subcommittee of the Human IRB.

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