What Are Decentralized Clinical Trials (DCTs)?
Clinical trials are a crucial aspect of modern healthcare. ClinicalTrials.gov shares that “In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet.”
Traditionally these clinical trials would take place in prestigious medical research centers and participating patients would travel to and from these research centers to receive the treatment. Although this model has led to FDA approvals in the past, it often aggressively limits the type of patients that can participate. If people want to participate in traditional clinical trials, they likely have to live within a reasonable distance from the participating research center, be capable of traveling to and from the research center or have a patient-partner who is able to assist them. Furthermore, the type of travel and time commitments associated with traditional trials can require time away from work, finding child care, and extended periods spent away from home.
Decentralized clinical trials (sometimes called hybrid clinical trials, virtual clinical trials, decentralized clinical research, etc.) address all of these challenges and more. The National Library of Medicine states “DCTs—also termed “direct-to-participant trials” or “virtual” studies— are characterized by less dependence on traditional research facilities or specialist intermediaries for data collection. 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.”
There are many different definitions of DCTs 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 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.
When did decentralized clinical trials start?
According to the National Library of Medicine, “On December 10, 2020, the Decentralized Trials & Research Alliance (DTRA) was launched, bringing together more than 50 international organizations, including the FDA and patient advocacy groups, to promote DCT methods.” Although the idea and implementation of decentralizing trials existed several years prior. DTRA was a way to offer guidance in best practices, promote new technology, and emphasize the power and importance of DCTs.
Since 2020, there have been enormous strides in the development and incorporation of DCTs in research centers. Currently The Decentralized Trials & Research Alliance “enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.” Their “vision is to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.”
Why are trials decentralized?
Put very simply, decentralized trials increase diverse recruitment and access, enhance patient engagement, and provide better patient experiences. By adding a decentralized component to clinical studies, trials become easier to participate in for a variety of reasons. DCTs compose a set of methodologies to add optionality to trial visits. This optionality gives patients the power to choose their health journey and actively participate in their care. Furthermore, this optionality allows patients who would normally not be able to access clinical research a chance to participate increasing and supporting diversity within the study.
Why is diversity important in clinical trials?
According to the U.S. Department of Health and Human Services and the National Institutes of Health, “It is important for clinical trials to have participants of different ages, sexes, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone. When clinical trials include diverse participants, the study results may have a much wider applicability.”
In other words, the more diverse a patient population is for a clinical trial, the more accurate the findings will be when applying them to the general population. It is important to include the demographics of all patients who could potentially receive the treatment being tested in order to understand the effects of the treatment in different groups of people. By decentralizing trials, researchers can ensure their study is reaching a wide population of potential patients while significantly expanding patient access to treatment.
What are key elements of decentralized trials?
Decentralized clinical trials (DCTs) can be used to describe a wide variety of trial methods most of which ultimately incorporate various decentralized components to allow the trial to take place in remote and community settings. Various DCT vendors can offer many different decentralized elements; furthermore, there are full-service DCT vendors that can offer all the necessary elements and allow research sponsors to pick and choose the decentralized study components that work best for them.
From a technology standpoint, DCTs may include: electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), eConsent, telemedicine, digital payments, wearables, direct-to-patient (DTP) recruitment workflows, EMR integrations, and notifications/reminders. Additionally, there are many site-based and trial management components that can be operated as DCT including remote patient monitoring, site-based and virtual Principal Investigators (PIs), inclusions of local practitioners, DCT platform and technology training for site staff, mobile nursing, mobile phlebotomy, virtual clinical research coordinators (CRCs) and much more.
Clinical trials have and continue to be a pinnacle for important medical advances today but, it is imperative for researchers and research centers to incorporate decentralized components to any study where possible in order to offer patient optionality, increase patient access, grow diversity, and expand trial capabilities and data collection.
Now that you understand DCTs, click to learn about Why the DCT Model Isn't "All or Nothing" and Why "Decentralized" Doesn't Mean "Virtual" In Clinical Trials