Understanding Various Decentralized Terms in Research
As many research organizations are becoming more patient-centric and adapting to technological advancements and remote requirements, they are re-designing the way they conduct research. Accelerated by the COVID-19 pandemic, many trials have shifted from being exclusively conducted in a brick-and-mortar site to a decentralized clinical trial (DCT) model. This approach is typically more convenient for the participant, and it allows research to continue despite in-person limitations.
Within the DCT model, there are various labels and definitions to know. These definitions can change and evolve quickly, so it can be challenging to keep up with all the terminology. In this blog, we attempt to clarify the terminology, defining decentralized clinical trials and the various terms falling beneath the DCT umbrella. We also outline what this may mean for the clinical research industry.
What are Decentralized Trials?
A decentralized clinical trial utilizes technology and processes to create options for participation beyond an exclusive physical presence at research sites. Unlike a traditional clinical trial where data collection and trial procedures are conducted entirely at a physical research site location, decentralized trials can enable telemedicine, remote collection devices, and mobile/local healthcare providers to provide additional options to participants for in-home visits.
You may have also heard terms like “hybrid,” “virtual,” and “remote trials” used in conjunction with—or as quasi-synonyms for—the decentralized trial concept. What do these terms have to do with decentralized trials? What’s the difference?
Virtual and Remote Trials
Catalyzed by the COVID-19 pandemic, virtual and remote trials incorporate data collection and participant interaction outside of physical site locations as much as possible. Participants provide informed consent remotely, researchers collect any samples remotely, and data is captured through wearables issued for the research or even through the participant’s own devices or apps. While study staff often remain centrally located, mobile medical providers may visit the participants’ home when the collection of specimens or data requires the presence of a trained medical professional.
A hybrid clinical trial incorporates a range of decentralized, virtual, and/or remote modalities of a clinical trial. It also integrates elements of a traditional randomized controlled trial, with strategic design elements to support real-world data collection. These design elements typically focus on randomization, can accelerate product development, and help lower the cost of data collection and participant follow-up.
Many organizations across the research community are learning the value of using new and innovative study designs to increase access to research, as well as increase the quality of data and quantity of information. As a result, industry stakeholders are now using the term “hybrid trials” and “decentralized trials” somewhat interchangeably.
Telehealth Versus mHealth in Research
Telehealth – also referred to as telemedicine – typically refers to patients receiving care from a healthcare professional without physically entering into a building to see them. There are multiple ways to conduct telehealth, including using video chat, communicating via text messaging or email, and utilizing other remote monitoring technologies (e.g., smart glasses) to conduct research-related interactions with the participant without an in-person visit.
Mobile health (mHealth), on the other hand, is typically used to refer to capturing health data via a smart device and may be useful in clinical research. Examples include electronic patient diaries, electronic patient-reported outcomes, monitoring apps, and devices to measure activity. While participants typically use mHealth to capture and track data about themselves, mHealth may also allow them to access clinical records and communicate with providers as needed.
What Does this Mean for Clinical Research?
The relative explosion of DCT designs and technology brought on by necessity to deal with travel restrictions related to the pandemic will forever change the clinical research landscape. Sponsors and research sites who embrace these new modalities should see the quality and consistency of their data increase while capturing more data from participants where it really counts: in their natural environment. Eliminating logistical barriers to participation also enables an expansion in the diversity and the sheer number of participants in research. Participants who previously could not travel to the research clinic during weekday business hours are now able to participate through televisits, in-home measurements and specimen collection, and digital mHealth tools which are convenient to use both in terms of time and location.
No matter the nuances or differences between each of these terms, each of them will continue to play an increasingly important role in clinical research, especially as we continue to adapt to the digital age. When designing a study, it’s important to utilize the best study designs and methodologies for the specific trial and participant population. Remaining as patient-centric as possible should continue to be the main goal for sites and sponsors as they work to advance clinical research safer, faster, and smarter.