Welcome to the Decentralized Clinical Trials (DCTs) monthly blog.
With patient-centric trial designs becoming a driving force in the drug development industry, we will be doing a series of monthly blogs that look back on recent events which give us insight into designing resilient clinical trials and ensuring study and data continuity.
For the last several months, it seems that the COVID-19 pandemic has impacted nearly every aspect of life – at home, at school and in the workplace – to create a “new normal” of social distancing and limited services. Clinical trials have been particularly impacted because of the pandemic’s global scale and the need for patients and CRAs to travel and be physically present at an investigator site to complete required study activities. Patient safety, study assessments, IP administration and data integrity are becoming increasingly difficult to navigate with several sites shuttered, patients and CRAs’ social distancing and the infrastructure that supports delivery of clinical trials grinding to a near halt.
The pandemic has accelerated a trend that was once perceived as futuristic, with home-based visit designs becoming more popular, and offering a potential advantage to sponsors to ensure patient contact and safety as well as study and data continuity. The importance of mobile phlebotomy for simple sample collection visits, or mobile nursing to conduct clinical assessments, study drug administration and collection of signs and symptoms, cannot be understated, as these services allow continued participation in trials from the convenience of the patient’s home. We expect this trend not just to continue, but to accelerate further. Surveys have shown that these patient-centric solutions are preferred because they reduce burden and limit disruptions to patients’ daily lives.
The utilization of mobile phlebotomy and nursing solutions is complex and requires detailed logistical and technological workflows that are integrated to prevent disrupting the site workflow. These solutions necessitate a global network of providers and country coordinators that can ensure quality delivery. In an age of shelter-in-place orders and reduced public transportation schedules, trial continuity is tangibly threatened. Mobile phlebotomy and nursing services can help ensure patient safety and study continuity.
We have been strategically redesigning the clinical trial process and our service offering, and recognized early on the need to offer reliable mobile health services on a global scale. For this reason, we acquired GlobalCare Clinical Trials, LLC. Now part of our family, GlobalCare will be fully integrated into our clinical trial solutions and allow us to offer cohesive services that seamlessly incorporate mobile nursing and phlebotomy solutions. Our aim is to reduce the burden of clinical trials for patients and optimize the site workflow to enable acceleration of key activities. Our acquisition of GlobalCare will enable us to scale this solution to start designing resilient trials. It will also allow us to provide a single collaboration engine for patients, nurses, CRAs and sites, and improve data transparency by providing near real-time data access to the investigator.
Mobile nursing, combined with our other unique services, will allow us to better support the “new normal” and make patient-centric solutions our “new normal” for conducting clinical trials, thereby improving the trial experience for patients, sites and customers. These solutions include our Patient Service Centers that allow patients to complete routine blood draws and biometrics at over 1,900 Labcorp facilities including participating Walgreens in the U.S., a patient-facing concierge contact center that provides logistical support to patients participating remotely and an interoperable digital health platform.
As we move forward with patient-centric trials being part of the “new normal” rather than a bleeding-edge innovation, we will continue our focus on patient safety and quality data generation. In this challenging time, it is critical that we listen even more attentively to our clients, our sites and our patients to enable trials that meet all necessary regulatory requirements, which are practical to implement and make protocol compliance convenient for patients.
Thank you for reading this month’s DCT blog. For more information on our acquisition of GlobalCare, please visit this link, or click here to download a brief overview.
To learn more about how we can help you build efficiencies into decentralized clinical trials, please visit our site.
You can also find additional DCT resources like case studies, white papers, scientific articles and more here.