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Embedded Clinical Trials: A Technology-Enabled Approach for Improving Clinical Research

Author: Verana Health
December 2021

Verana Health’s Chief Medical Officer, Matthew Roe, MD, MHS, shared his perspective on the future of embedded clinical trials in a November 2021 presentation at the Australian Clinical Trials Alliance Annual Scientific Meeting.

In Dr. Roe’s presentation, titled “International Perspective on Embedding Clinical Trials in Health Care Settings,” he discussed the importance of developing strong community trial site networks and reusable data and technology infrastructure to power and facilitate trials repeatedly without having to build a new operational apparatus each time a new trial begins.

An embedded clinical trial is one that is integrated within healthcare delivery settings, designed to be easy and valuable for both patients and clinicians to participate, enabled by streamlined research workflows that fit into clinical care, and uses existing electronic health record (EHR) data generated during routine care delivery to plan and execute the trial.

Specifically, there are four types of embedded clinical trials: 

  • Registry-based trials: Leverage an existing registry infrastructure to operationalize the trial and use registry data as the primary source of data collection.
  • Real-world-data-enabled trials: Leverage available real-world data (EHR and claims data) to operationalize the trial and act as the primary data source for the study database. 
  • Large, simple trials: Leverage pragmatic trial approaches to simplify all aspects of the trial, making it easy to enroll, conduct, and complete; and thus, facilitate embedding it into care delivery through streamlined processes. 
  • Technology-enabled trials: Leverage reusable technology integrations and solutions to streamline trial conduct, connect disparate real-world data sources to operationalize the trial, and facilitate participation of patients and clinicians. 

As the industry looks to the future for reusable, streamlined approaches for embedding clinical trials, it has become clear that real-world data and technology solutions will be the key features needed to accomplish these goals on a repeatable basis. Dr. Roe also shared his perspective on this desired future-state in a post earlier this year

Ultimately, a future of data-driven, technology-enabled embedded clinical trials will benefit both patients and clinicians by making trials more accessible and inclusive. As we look forward to a robust and active year ahead, Verana Health is eager to continue to collaborate with all partners and stakeholders as we embrace this future vision.