The Aperio Blog

Demystifying the Decentralized Clinical Trial 

Part I: Taking on Terminology  

Cari KniolaDirector, Corporate Strategy
April 14, 2021

COVID-19 lit a fire under decentralizing clinical trials. In one survey of biopharmaceutical and medical device companies and CROs, 76% of respondents reported that the pandemic has accelerated their company’s transition to decentralized clinical trials, with at least some of their trials already decentralized. 38% of respondents reported having decentralized at least half of their clinical trials. Nevertheless, about half of respondents also reported concerns about the clarity of regulatory guidance regarding decentralized trials and data collection.

While everyone is talking about decentralized clinical trials, there is more confusion than clarity about just what this means. The confusion starts with terminology. Are decentralized clinical trials the same as virtual clinical trials? Where do siteless trials and hybrid trials fit in? Can the same trial be called decentralized, virtual, siteless and hybrid, or are we talking about four different things?

“Siteless” Trials Are Rare

For the purposes of this discussion, “virtual trials” will refer to what are often called “siteless trials.” The label “virtual trial” implies that all clinical trial activities are performed outside of a physical site location via online recruitment / enrollment, patient wearables, telehealth, home health visits, direct-to-patient Investigational Product (IP) shipment, etc. The number of trials that are truly ‘siteless’ remains relatively small and fits a particular niche of study, such as late phase, observational / registries, or even some digital therapeutics trials.

In the case of a siteless or virtual clinical trial, there is likely a central investigator site that manages many tasks historically delegated to a multitude of clinical trial sites with offices anywhere from a few to hundreds of different locations. In these trials, patient-based activities are pushed out toward patient homes while other study tasks are completed at the central site.

One example of a virtual or siteless trial is DCRI’s iPERSONAL Study for Children and Teens with Lupus. This clinical study is run out of Duke University, is recruiting patients from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry, and has research staff provided by Science37. Data is collected virtually via telehealth, home health visits, ePro devices, and patient wearables.

Most Decentralized Clinical Trials Are “Hybrid” Trials  

The “hybrid” label acknowledges the reality that a preponderance of decentralized clinical trials can only decentralize a subset of activities. This subset may be limited to areas such as web-based patient recruitment and screening or may be more extensive, with activities like data capture and assessments performed in patient homes with the aid of mobile or wearable devices, telehealth, and home nursing visits. Because the overwhelming majority of decentralized clinical trials make select activities ‘virtual’, almost all decentralized trials are hybrid trials. Their design might look something like this:

 

Visit Location Study Tasks
Consenting Home eConsent
1 Site Physical exam, vitals, medical history/conmed collection, screening labs, screening imaging, enrollment / randomization, provide ePro tablet, dispense IP
2 Home Telehealth visit to assess AEs, home nurse visit to collect safety labs, daily ePro diary
3 Home Telehealth visit to assess AEs, home nurse visit to collect safety labs, daily ePro dairy
4 Site Return IP, return ePro tablet, physical exam, vitals, collect final safety labs
5 Home Follow-up telehealth visit to assess AEs

 

There Are Many Levels of Decentralization

The term ‘decentralized’ is so often associated with ‘siteless’ that a lot of us may not realize the level of experience we actually have with decentralizing a clinical trial. Have you given patients a tablet to complete a diary at home so they wouldn’t have to come to the investigational site to turn in their paper diary? Have you provided patients with an eConsent portal, so they could review the study information and the consent from the comfort of their home? Did you send a nurse to the patient’s home to collect safety labs, so they didn’t have to come to the site? Your study could include one or all of these examples, and it would have had an aspect of decentralization.

These individual pieces of decentralizing a clinical trial are not necessarily new. What is new is the challenge of seeing how many of these components we can fit into a trial, the drive for technology to make decentralization more streamlined, and the overall approach of making studies convenient and accessible for the patients.

Join us in Part 2 of this series, where we will discuss the pros and cons of decentralizing your clinical trial.

Cari Kniola

Director, Corporate Strategy

Cari’s role in Corporate Strategy includes oversight of marketing and proposals, and working with the C-Suite in developing and executing strategic corporate development and growth.

Cari has over 22 years of clinical research experience in both pharmaceutical and medical device studies. During her career she has served in various roles, including study coordinator, field based CRA, clinical trial manager and eight years in project management. Her operations experience included roles with sites, sponsors and CROs, and she understands the challenges that each face. For the last two years, Cari’s role has focused on the corporate side of clinical research, using her operations experience and business acumen to drive proposals, marketing and corporate strategies.

When not planning Aperio’s next move, Cari spends her free time strolling on the Lake Michigan shoreline, hiking in the Indiana Dunes and fulfilling her obsession with LEGOs.