While the adoption of decentralized clinical trials continues to grow, patients currently do not have a central application to track drug or ancillary material shipments, request a specimen pick-up, find a drop-off location, and schedule a home healthcare provider visit for protocol assessments, sample and specimen collection. Now, patients can access these features through a new platform that’s part of a partnership between Marken, UPS Healthcare’s clinical trial logistics unit, and THREAD, a decentralized clinical trial technology provider.
 
The companies recently partnered to bring together THREAD’s digital platform and Marken’s Home Healthcare and clinical trial logistics services to create a single seamless workflow for clients and patients. With the platform, sponsors and CROs don’t have to manage individual logistics and decentralized clinical trial platform vendors to set up a study. It also allows patients to coordinate all aspects of trial participation, from consent to sample analysis, with a single entity.
 
UPS Healthcare President Wes Wheeler shares insights about the partnership, the new platform, and the inspiration behind it. –KB
 
Contract Pharma: Please briefly describe the partnership with THREAD and how it works.
 
Wes Wheeler: Marken and THREAD recently announced a strategic partnership to support the first-ever in-home, unified solution for decentralized clinical trials. The new experience combines THREAD’s digital platform with Marken’s clinical trial logistic services to make the overall workflow of a clinical trial easier for the sponsors and patients, pulling everything into one convenient location. More specifically, patients can now coordinate all aspects of their clinical trial participation through one service.
 
The pandemic drastically changed how trials are conducted. It’s estimated that roughly 50% of trials were in “rescue mode” in 2020 due to the inability of medication delivery to subjects and continuing study visits. For years the industry has grappled with the idea of enabling at-home trials. The time has come to execute on this idea and make it a reality for both patients and sponsors.
 
Overall, the healthcare industry continues to trend toward at-home service, which was extremely evident throughout the pandemic. Marken is continually looking for new technologies and digital innovations to improve the overall patient experience.
 
This new offering joins Marken’s other patient-centric solution offerings, including Home Healthcare (HHC), Clinical Trial Logistics and Direct-to-Patient/Direct-from-Patient distribution services.
 
CP: What are the key challenges associated with decentralized clinical trials with respect to logistics and the digital technologies needed to run them?
 
WW: One key challenge associated with decentralized clinical trials is the limited amount of secure digital solutions that allow sponsors to manage the trials remotely, as well as accurately collect and manage trial data, while maintaining patient compliance.
 
Data tracking and data quality, particularly for those trials that aren’t used to working with virtual solutions, can be quite difficult as these represent potential risks as sponsors have limited ability to control or close the gaps in quality. Having the ability to collect both structured and unstructured data in a virtual setting offers multiple organizations and vendors the opportunity to collect and report real-time data throughout a clinical trial, while enhancing the quality of that data.
 
Logistics can be incredibly complex in a DCT model, as many vendors may not fully understand what is required for turnaround times, particularly in cases where medications may need to maintain a certain temperature throughout the process, as it’s delivered to a trial participant.  
 
CP: How can these challenges be addressed?
 
WW: Creating a detailed playbook for each decentralized clinical trial is a critical first step to addressing common challenges. This playbook should highlight the timeline, roles and responsibilities for all involved parties and clear and concise instructions for patients and sponsors to ensure everyone is aligned from the start.
 
Additionally, it’s imperative to gather and input all the information into one platform, which our partnership with THREAD accomplishes. This way all the details involved in the trial process is in one place, eliminating issues with incompatible software, data transfer errors and more.
 
Investing and implementing the right technologies can help sponsors, CROs and vendors shift from traditional on-site trials to a decentralized method. A unified platform or tech stack that brings everything together in one area to streamline and analyze data allows for more accessibility for trial participants and vendors alike, not to mention can enhance the overall patient experience. 
 
Effective staff training is a must to ensure the success of digital trials. It’s imperative for staff to know the software and platform inside and out so they can accurately support patients and sponsors input and access and analyze the information throughout the study. Additionally, with the proper training, techniques and resources, staff will be able to troubleshoot relevant issues that could arise with patients, ensuring they minimize tech-related concerns.
 
CP: How does the new platform work? (for sponsors, CROs, and patients)
 
WW: The new Sponsor, CRO and patient experience works through a tight and seamless integration between THREAD’s digital platform and Marken’s Apollo management system, pulling all trial data and detail into one convenient location.
 
Specifically, users will be able to log into a single application to view the overall study progress, specific patient visit history and details about specific activities within a visit. This information can also be securely extracted and sent to the CRO and/or Sponsor to be imported in an EDC platform.
 
This collected data, which includes everything from overall consent forms and trial guidelines in-home visit information to patient outcomes, are all protected and secure to ensure it follows HIPPA guidelines.
 
CP: What do you anticipate in the near term for decentralized trials?
 
WW: Decentralized trials are here to stay. The pandemic accelerated the development and implementation of various technologies in the healthcare industry, which is particularly evident in the decentralized clinical trial space. I believe over the next several years, more CROs, sponsors and vendors will continue to adopt new technologies and the shift to decentralized trials will continue to push forward as patient demand for at-home, convenient service increases.
 
Sponsors, providers and patients will continue to look for opportunities to incorporate technology in safe, secure and more efficient ways to collect, store and analyze data that’s measured and collected.
 
Additionally, as this technology is adapted by sponsors and patients, it’s going to be easier to engage and retain patients, which will ultimately provide stronger data collection to help address key issues impacting the market. 
 
As the industry continues to understand its approach and design to DCTs, there must be a truly deep understanding of the patient and their needs. DCTs will continue to evolve over time and must meet the patient where they are. It will be imperative for sponsors and CROs to provide patients with relevant, adaptable experiences, based on their personal environments, that offer streamlined options, easy workflows and greater accessibility.