This webinar will provide a basic understanding of how devices work, how to identify quality devices, how to get the most value from the information collected, and how to be well positioned for the growth in this field. The new mobile devices guidelines provided by the Clinical Trials Transformation Initiative (CTTI, a private/public partnership initiated by Duke University and the FDA) will be reviewed.
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.
- 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- Do you know how to prevent your data from going out of date as the technology changes?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