Decentralized Clinical Trials (DCT) Monthly Blog – October 2021

This month in the blog, we are going to look at how new options within the U.S. for handling investigator oversight of clinical trials.

When the concept of decentralized clinical trials (DCTs) was new, there was a lot of discussion about eliminating the investigator sites entirely. The idea behind this was that by eliminating them, and using centralized review of medical data while outsourcing other traditional investigator functions such as recruitment, a more efficient and patient centric model would emerge, delivering substantial cost savings to sponsors.

Instead, what we have found is that for most registrational trials, it makes sense to maintain an important role for traditional investigator sites, both in terms of local recruitment and medical oversight, while at the same time bringing as many services closer to the patient as makes sense: home visits by mobile clinicians, app-based ePRO reporting, Televisits, and so on. This balanced role of the investigator site benefits them as well: they perform less routine/administrative work per patient, and are able to have the capacity to enroll and oversee more patients. Most DCTs we work on use this win-win approach.

There are some studies, however, including some post-marketing & real world evidence studies, as well as certain device and consumer product studies, where there actually is no need for any in-person visits by participants at an investigator site. For cases like this that are fully decentralized/virtualized projects, we are pleased to introduce the Decentralized Clinical Trial Investigator Network, in partnership with Circuit Clinical®.  This network covers the United States and provides appropriately credentialed investigators for each state from which patients are to be recruited.  They provide remote oversight and medical data review, without requiring patients to physically visit them. In this model, patients may have samples collected at their home via our Mobile Clinical Services team, or at a convenient Labcorp Patient Service Center near their home or work location.  All screening, identity verification, enrollment tasks, and outcome reporting can be done via our online tech platform, either over the web or via convenient mobile applications.

In addition to reducing participant burden, this model saves investigators considerable effort because all of the investigators can be centrally contracted through the DCT-IN, replacing the model where each investigator is contracted separately.  By streamlining the budget and contracting process, studies startup can be accelerated. There is also the benefit of central IRB submissions and regulatory document management.  And due to Circuit Clinical’s site infrastructure and experience running traditional clinical studies, our new service is fully regulatory compliant. By eliminating the need for physical site visits, it is practical to enroll a more diverse participant group, targeting any under-represented groups needed to ensure study validity.

You can learn more about the DCT-IN HERE [hyperlink to DCT IN one pager], and you can also hear about this model at the Mobile in Clinical Trials conference on Monday, September 27, at 2:15pm US Eastern Time, from Kristen Andrews. She is our Senior Director for Site Centric Solutions, Feasibility, Recruitment, and Engagement.  This virtual presentation will not just introduce how the DCT-IN works, it will present a use case showing how the various elements of a fully decentralized trial can be put together. If you can’t make it to the presentation, stay tuned for a link to the presentation that you can view whenever is convenient for you.

Thank you for joining us here at the Labcorp DCT blog.  Next month, we will discuss the use of DCTs as applied to pediatric trials, and some new tools to keep youth engaged in the process.