The world of drug development is constantly changing. Innovation and Veristat new technology have revolutionized the traditional clinical trial design. However, drug developers are struggling with how to shift from conventional methods to the latest ones. The industry is using different terms to address a seemingly one main idea: replacing traditional in-person activities in clinical research with digital interventions.
For this reason, you can easily get confused about differentiating decentralized clinical trials from virtual and hybrid—which is which? Below, we explore the main differences between the three to help choose the most suitable model to use in your clinical trial planning.
Understanding How Decentralized, Virtual, and Hybrid Trials Are Different
The three may seem like one main idea expressed in different ways. Each term represents a separate trial design that offers specific benefits and challenges to modern clinical trials. Let’s dive deeper to learn their differences.
What Is a Virtual Clinical Trial?
A virtual clinical trial replaces much (or all) of in-person activities in a clinical trial using software solutions, wearables, and other digital technologies. A fully virtual trial is entirely technology-based—no physical locations, in-person interactions, and no traditional clinical trial sites. Everything is completely virtual, from study start-up to patient enrollment to data collection and testing. In short, no physical patient-caregiver interaction—only data movement. However, virtual clinical trials barely exist since nearly all clinical studies rely heavily on human-to-patient interactions to succeed. Most trials using this model are partly virtual because they are technology-enabled.
What Is a Decentralized Clinical Trial?
It’s a clinical study that uses technology and local healthcare providers to bring the trial closer to the research patients (away from the central site). While decentralized clinical studies can be virtual, the model focuses on eliminating the burden of travel on research participants. Patients may not reside near a traditional clinical trial site. A decentralized clinical model moves the research closer to the participants from the main study center, which could be their local health center or homes.
Key takeaway: While a decentralized clinical trial can be conducted remotely and away from the main research center, it doesn’t have to be fully virtual. If trial leaders work with mobile health networks and local physicians, they can still perform in-person patient tests. A decentralized clinical trial aims to bring the study as close as possible to patients. This model is sometimes called a direct-to-participant clinical trial.
What Is a Hybrid Clinical Trial?
Hybrid clinical trials are partly virtual and partly in-person. They include both traditional and digital clinical research elements. Think of a mixed clinical trial as remotely monitoring participants but requiring them to visit the clinical site occasionally. It combines technology like eConsent forms and remote data collection with traditional on-site workflows to develop a smooth study experience. Here’s the best way to think of a hybrid clinical trial: traditional clinical research enhanced with virtual elements. Most areas of drug development are not ready for full virtual monitoring and decentralization. Most trials are too complex, so removing human supervision from the study protocol can make them fail.
For these clinical trials, a hybrid model is the most suitable approach that accommodates the preferred levels of technology enablement and human intervention. Most modern trials qualify as hybrid trials.