Learning from Experience: Recent Case Studies Guide DCT Trial Design – November 2021

Welcome to the November 2021 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. This month, we are looking back at some great case studies we’ve just published, and will give a sneak peek at our upcoming presentation at the Dynamic Global Events Virtual Clinical Trial conference in December.

When sponsors speak with us about incorporating DCT methodologies into their trial design, one of the most helpful things we can do is provide a case study that relates to the challenges that their trial poses. Let’s look at a few examples where incorporating Mobile Clinical Services (MCS) into a protocol made the sponsor’s trial more accessible to the patient population, while streamlining the efforts needed by the sponsor. A common need in certain rare disease trials is in-home services such as IV infusion of investigational product. This can be challenging for several reasons, not the least of which is that the process can take up to three hours, depending on the protocol. One sponsor came to us for help with a series of trials that would span 14 countries, needing not just the mobile clinician support to provide in-home services in these various countries, but also the expertise to manage the distribution of the investigational product itself. We were able to provide mobile support across all needed countries—including to areas that were rural or otherwise remote—along with central pharmacy services and cold-chain support to ensure the study drug was infused into the patient within stability. Through this entire process, a strict compliance monitoring protocol was followed. During a five-year period, more than 5,200 visits were conducted by our mobile clinicians. Read the full story here.

In another situation, the COVID-19 pandemic caused significant disruption to a pediatric neuromuscular clinical trial. The impact of the pandemic on clinical trials worldwide is well known, but this case study demonstrates how the inclusion of support for home visits allowed the MCS visits to be rapidly “switched on,” minimizing disruption to the study and preventing many patients from having to drop out. This study provided for the use of our MCS services in about 20 countries, each of which had its own unique and varying circumstances during this unprecedented time. By reducing the need for patients to go to visits at the investigator sites, we were able to promote the safety of all involved, demonstrating a significant increase in trial resiliency due to the inclusion of provisions for MCS support by the sponsor. While not all of the countries actually needed to use these MCS services to replace site visits, 12 countries did, allowing 136 patients to continue participating in the trial. Read the full story here.

Before we conclude this month’s blog, we want to call your attention to the upcoming Dynamic Global Events Virtual Clinical Trial conference. We are proud to be sponsoring this event, and will be presenting a talk titled: “Not feeling the connection? Three ways moving to digital workflows will improve the clinical trial experience.” John Cassidy, our Global Head of Product & Commercial, eClinical, will talk about the move to digital workflows connecting MCS and other elements of DCTs, with a focus on closing gaps and reducing risk. Through a case study approach, he will review the benefits of using a comprehensive digital platform and how it applies to real-world scenarios. We hope to see you—virtually!—there on December 15-16.

That wraps up this month’s DCT blog. Next month, we will have additional case studies and new capabilities to talk about!

Learning from Experience: Recent Case Studies Guide DCT Trial Design – November 2021

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