Use of Wearable Devices in Clinical Trials

This ‘Wearable Devices in Clinical Trials Webinar’ will provide insights into how wearable devices work, how to find quality devices, how to derive the optimum value from the collected information, and how to position your business for the growth in this field. It will also review the new mobile devices guidelines of the Clinical Trials Transformation Initiative (CTTI, a private/public partnership initiated by Duke University and the FDA).

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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Jul-2019

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Why Should You Attend:

The application of wearable devices to a clinical trial is not just about procuring many consumer devices, providing them to the subjects, and integrating the readings into your study data. Such an approach might not provide the quality data required to support crucially important decisions in drug development.

For instance:

  • How do you know all 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  • Do you know how to prevent your data from going out of date as the technology changes?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?

There is great potential for improving and lowering the cost of drug development with the application of wearable devices to clinical trials. However, given the technical complexity of the devices, and the nature of the flooded consumer devices market, the conversion of the data to useful endpoints is a field that is not completely mature, and the regulatory environment is still evolving.

This course explores the limitations and capabilities of wearable devices for collecting real time data in clinical trials. It discusses the regulatory problems and delivers 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
Instructor Profile:
Barry Peterson 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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