Experts expand on the need for a comprehensive understanding of all sources of data in DCTs, and the need to evaluate those data centrally in real time to mitigate the risks associated with their capture (including data capture at the edge of the network (wearables)).

Every disruptive innovation must be complemented by adapted procedures, and this also applies to decentralized clinical trials (DCTs). Traditionally, sites entered clinical trial data in an Electronic Data Capture (EDC) system and these source data were verified at the site to confirm accuracy. Risk based monitoring focused on site level metrics such as screen failure rates, query rates, Serious Adverse Events (SAEs) reported, missed/late visits, etc. With DCTs, as source data are collected directly from participants this is no longer an option and a different approach is required to ensure the quality and integrity of the data. As a rule, a comprehensive understanding of all sources for data capture in a clinical trial and the process for centralization is essential. Also, it is important to evaluate the data collected in real time to allow early interventions that will ensure data integrity for regulatory submission.

In this webinar, Chitra Lele describes how centralized monitoring strategies can help aggregate and analyze data in real time and provide insights to a variety of functional teams across the trial continuum. Daniel Gutierrez describes how the Clinerion platform can boost data integrity in DCTs. The technology transforms global data sources to one query-able data model for structured medical data, while ensuring that the data keep its full resolution and integrity during aggregated queries.

Pierre Etienne talks about the expanding role of mobile Health Care Professionals (HCPs) and their crucial role in protecting data integrity. Clifton Chow finishes with a comparison of several artificial intelligence (AI) based binary classifiers for detecting the integrity of data obtained from Internet of Things (IoT) enabled wearable sensors.

Key Topics Include:

  • How centralized statistical monitoring works for DCTs.
  • Expanding role of mobile HCPs and their crucial role in preventing the spread of corrupted data in collaboration with the central statistical monitoring team.
  • Methods to identify and reject corrupted data from wearables (at the network edge).
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Presenters

Founder and President
Actu-Real, Inc.

Chitra Lele is a strong business leader with proven expertise in both strategy and operations, including entrepreneurial experience, along with a solid research and academic foundation; ability to connect the dots and offer solutions for unmet needs.

Director
Customer Solutions
Clinerion Ltd

Dr. Daniel Gutierrez is a Cardiac Physiologist by training. He obtained his degree from the University of Bern in Switzerland and later on developed his Post-doc at ETH in Zurich. At Clinerion (an Informa Company), Daniel is responsible for managing the hospitals that conform the Clinerion Network.

Co-Founder & CMO
Actu-Real, Inc.

Dr. Pierre Etienne is a well-recognized thought leader and scientist, with strong research as well as business acumen; extensive experience both in the pharma industry and in academia, research, and clinical practice.

HEOR Consultant
Health Economics and Outcomes Research (HEOR)
Actu-Real, Inc.

Dr. Clifton Chow is a health economist and policy analyst with over 20 years of health economic outcomes research (HEOR) experience. Prior to joining Actu-Real, he had been a director of HEOR with consulting firms that produced economic models, systematic literature reviews, and value dossier submissions for biotech and pharmaceutical clients.

Production Partner

Actu-Real

Actu-Real combines cross-functional skillsets to provide solutions to quality, cost and access challenges in healthcare for pharmaceutical cos, insurers and healthcare providers.

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