Technical professional organisation IEEE and the IEEE Standards Association (IEEE SA) have announced the launch of an IEEE Industry Connections activity entitled Technology and Data Harmonization for Enabling Remote Clinical Trials.
As a first step, an assimilated forum will be established for evaluating and testing the best methods to achieve data outputs and capabilities supporting clinical trials, which will require extensive process changes in order to evolve into the digital era.
Technologies, such as artificial intelligence (AI), blockchain and distributed ledger technologies (DLT), the Internet of Things (IoT), sensors and virtual and augmented reality (VR/AR), in combination with current technology systems, will be explored for improving remote clinical trials, from patient recruitment through to FDA submission.
Participants in the IEEE Technology and Data Harmonization for Enabling Remote Clinical Trials initiative will develop a consensus-driven workflow that will later be tested against a simulated clinical trial to prove the following outcomes: a more efficient and inclusive patient recruitment and engagement process; restored data integrity and validation, requiring fewer resources for audit and submission for approval; ability to enable one original and immutable patient log from informed consent through the publication of trial results; and reduction in cost and time for securing and establishing sites, patient recruitment and retention, quality control and audit of data.
Maria Palombini, director, Communities & Initiatives Development Emerging Technology, IEEE SA, will moderate the panel discussion and 1 hour workshop Tech & Data Harmonization for Enabling Remote Clinical Trials at the upcoming ConVerge2Xcelerate (#ConV2X) health-technology conference to be held on October 15, 2019 at the Seaport World Trade Center in Boston, MA.
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