Why "Decentralized" Doesn't Mean "Virtual" In Clinical Trials
September 1, 2022

What does decentralized mean? 

The word ‘decentralized,’ according to the Merriam-Webster dictionary is concisely defined as “the dispersion or distribution of functions and powers.” Furthermore, the Cambridge Dictionary states that “if a large company or organization decentralizes or is decentralized, its activities are moved from one large central place to several different, smaller places.” Note that the word itself does not inherently imply a means in which powers, services, functions, etc. are dispersed. 

Decentralized Clinical Trials 

Decentralized clinical trials or DCTs however are defined by the National Library of Medicine as being “characterized by less dependence on traditional research facilities or specialist intermediaries for data collection.” Although the definition does include an affiliation with the term ‘virtual clinical trials’ and explains that “DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes,” this isn’t exclusively true. Virtual clinical trial elements within a study can help decentralize a trial but are not necessary for doing so either. 

What does virtual mean in a clinical trial setting? 

Although many individuals in the clinical trials industry use the phrases “decentralized clinical trial,” “virtual clinical trial,” “siteless trial,” and even “digital clinical trial” interchangeably, this is typically not accurate. Most decentralized clinical trials can have a variety of virtual tools incorporated into the study with it being a fully ‘virtual clinical trial.’ A fully-virtual clinical trial describes a trial that takes place in a 100% virtual setting. This can include components of a decentralized clinical trial platform like telemedicine, use of virtual ePRO software, eConsent software, treatment shipments, etc.- the main point being that all elements of the trial take place in only a virtual setting. 

Decentralized trials may also use many if not all of the same components as virtual trials, but not all decentralized trials do. In fact, a decentralized clinical trial can be run with very minimal incorporation of virtual tools or a decentralized clinical trial platform (DCT platform). Every decentralized trial is different, the type of study components chosen should be based on the specific needs of a study and not based on the idea of what a study should be. 

So why does decentralized clinical trial not mean virtual clinical trial? 

There are many different definitions of decentralized clinical trials that exist today however, most follow the same premise. Decentralized clinical trials are clinical trials that incorporate various technologies, services, and health professionals into the study design which ultimately allow a study or parts of a study to take place in non-traditional settings. These settings can be completely virtual in which patients don’t ever have to leave their homes to participate but they can also include the utilization of local sites and physicians in patients’ own communities requiring some in-person aspects without making patients travel to physical, brick-and-mortar research centers.

Despite the fact that many use the terms ‘decentralized clinical trial’ and virtual clinical trial,’ interchangeable, the most important takeaway to understand is that decentralized clinical trials have the capacity to exist in many different forms and models. One benefit of decentralizing clinical trials is that virtual trials can exist but that is just one type of decentralized trial. For more examples of what different decentralized trials can look like - both virtual and not - read our whitepaper here to learn about different types of decentralized trials that we’ve conducted in the same therapeutic area. 

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Why "Decentralized" Doesn't Mean "Virtual" In Clinical Trials

September 1, 2022

Decentralized clinical trials have the capacity to exist in many different forms and models, where decentralized study components can be incorporated in a way that best first a specific study's needs

What does decentralized mean? 

The word ‘decentralized,’ according to the Merriam-Webster dictionary is concisely defined as “the dispersion or distribution of functions and powers.” Furthermore, the Cambridge Dictionary states that “if a large company or organization decentralizes or is decentralized, its activities are moved from one large central place to several different, smaller places.” Note that the word itself does not inherently imply a means in which powers, services, functions, etc. are dispersed. 

Decentralized Clinical Trials 

Decentralized clinical trials or DCTs however are defined by the National Library of Medicine as being “characterized by less dependence on traditional research facilities or specialist intermediaries for data collection.” Although the definition does include an affiliation with the term ‘virtual clinical trials’ and explains that “DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes,” this isn’t exclusively true. Virtual clinical trial elements within a study can help decentralize a trial but are not necessary for doing so either. 

What does virtual mean in a clinical trial setting? 

Although many individuals in the clinical trials industry use the phrases “decentralized clinical trial,” “virtual clinical trial,” “siteless trial,” and even “digital clinical trial” interchangeably, this is typically not accurate. Most decentralized clinical trials can have a variety of virtual tools incorporated into the study with it being a fully ‘virtual clinical trial.’ A fully-virtual clinical trial describes a trial that takes place in a 100% virtual setting. This can include components of a decentralized clinical trial platform like telemedicine, use of virtual ePRO software, eConsent software, treatment shipments, etc.- the main point being that all elements of the trial take place in only a virtual setting. 

Decentralized trials may also use many if not all of the same components as virtual trials, but not all decentralized trials do. In fact, a decentralized clinical trial can be run with very minimal incorporation of virtual tools or a decentralized clinical trial platform (DCT platform). Every decentralized trial is different, the type of study components chosen should be based on the specific needs of a study and not based on the idea of what a study should be. 

So why does decentralized clinical trial not mean virtual clinical trial? 

There are many different definitions of decentralized clinical trials that exist today however, most follow the same premise. Decentralized clinical trials are clinical trials that incorporate various technologies, services, and health professionals into the study design which ultimately allow a study or parts of a study to take place in non-traditional settings. These settings can be completely virtual in which patients don’t ever have to leave their homes to participate but they can also include the utilization of local sites and physicians in patients’ own communities requiring some in-person aspects without making patients travel to physical, brick-and-mortar research centers.

Despite the fact that many use the terms ‘decentralized clinical trial’ and virtual clinical trial,’ interchangeable, the most important takeaway to understand is that decentralized clinical trials have the capacity to exist in many different forms and models. One benefit of decentralizing clinical trials is that virtual trials can exist but that is just one type of decentralized trial. For more examples of what different decentralized trials can look like - both virtual and not - read our whitepaper here to learn about different types of decentralized trials that we’ve conducted in the same therapeutic area. 

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