In this free webinar, the featured speakers will present a strategy to identify devices that are “fit for purpose” and outline a framework for Digital Endpoint selection and validation to ensure the outcome measurement is robust, reliable and interpretable. They will address the key considerations that arise when using digital technology to support endpoint generation in clinical studies such as Device Selection, Endpoint Reliability and Sensitivity, Meaningful Change Thresholds and Analysis Strategy and Interpretation.
TORONTO (PRWEB) May 07, 2020
The COVID-19 pandemic has heightened interest in mHealth and mobile technology to capture patient insights outside of the traditional clinical setting. Although mHealth devices and sensors are continuing to evolve, and it is now possible to capture a vast array of physiological data, the operationalization of digital trial is not without challenges.
Now more than ever there is a need to generate data from connected devices that are robust, reliable and relevant, of sufficient quality and ensuring minimal data loss. At the heart of the decision to use a digital device in a clinical programme is the study objective. However, as more of these technologies are being used in clinical studies, questions are arising as to how to ensure that the data generated by these devices can be validated and used to support endpoints.
In this webinar, it will be proposed how the application of COA principles and techniques can build the evidence package, when considering the evidence required to support digital endpoints for their submission to regulatory bodies and reimbursement stakeholders.
Join Marie McCarthy, Senior Director of Innovation, ICON, Rachel Ballinger, Principal, Patient Centred Outcomes, ICON and Hannah Lewis, Principal, Patient Centred Outcomes, ICON in a live webinar on Friday, May 22, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Digital Endpoint Strategy and Validation.
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