Why the DCT Model Isn't "All or Nothing"
With the rapid adoption of DCT trials and other health technologies in 2020, many have grown quite familiar with the concept of digital or remote health.
However, many associate digital health with being a fully remote/virtual model of care that was necessary under the strenuous conditions of the pandemic. What is often misunderstood, is that the implementation of these virtual/remote tools does not limit necessary in-person care or inhibit other health services to take place in a traditional or brick-and-mortar care setting. In fact, these tools and technologies, when implemented strategically, allow for a decentralization of healthcare that can revolutionize how and when patients receive care.
Furthermore, a decentralized care model can expand patient access to care, particularly in clinical trials, where patients may not otherwise have access to experimental treatments.
What is a DCT model?
DCTs or decentralized clinical trials, according to the Decentralized Trials & Research Alliance, are “clinical trial[s] utilizing technology, processes, and/or services that create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site.” In other words, decentralized clinical trials (sometimes called hybrid clinical trials, virtual clinical trials, siteless trials, decentralized clinical research, etc.) are a type of clinical study that utilizes a variety of services, tools, and technologies with the capacity to alleviate many physical location restrictions that typically exist with clinical studies.
With the right DCT vendor, this decentralized trial model can be implemented for a variety of different studies across many therapeutic areas including pharmaceutical/drug, infectious disease, digital therapeutics (DTx), medical devices, and much more.
A Model Built For Versatility
Decentralizing a trial can take on many different forms and so the concept of decentralized trials should be seen as a malleable model.
When people think of decentralized clinical trials, they may make the assumption that they correlate to fully virtual trials. Although this isn’t incorrect, virtual clinical trials are just a singular type of decentralized trial. When understanding DCT models, it is first important to understand Why "Decentralized" Doesn't Mean "Virtual" In Clinical Trials.
Many decentralized trials do still require in-person elements of care. In this circumstance, a hybrid decentralized model could be considered, however, is not always the best fit. This is because the right DCT vendor can implement the necessary decentralized elements into a trial, without requiring additional third-party software or platforms, while maintaining the desired study model. Meaning a sponsor has the ability to run a fully traditional (or brick-and-mortar) trial while being able to include as little as just one DCT element.
For example, a clinical trial for oncology, that requires the majority of patients to be seen by specific principal investigators (PIs) in person and consistently for six months may not initially require many DCT elements. However, after the initial six months, these participating patients need to fill out ePROs for several years following treatment. In this case, DCT technology and/or eClinical software can be incorporated early on in the study design with the intention to be implemented for long-term patient follow-up, ensuring patients remain engaged with high retention rates while collecting eCOAs that are protocol compliant.
Although a full-service DCT platform can offer sponsors and clinical trial sites a wide variety of capabilities to decentralize various components within a clinical study, this does not mean they all have to be used. The right DCT vendor can allow sponsors to pick and choose the right decentralized eClinical services, trial support software, and DCT technology that’s the best fit for their study.
You can learn more about specific DCT study design in Curebase’s DCT Vendor Guide.