In order to understand the nuances of virtual (i.e. remote-based) and traditional (i.e. brick-and-mortar) trial sites, we need to first understand decentralized clinical trials (DCTs). The exact definition of decentralized clinical trials varies, but essentially boils down to this: DCTs move research into patients’ homes and real-world medical settings through the use of technology and local healthcare providers.
Often, the label “DCT” is misnomered as digital clinical trials, but it is important to note that decentralized does not necessarily mean digital. DCTs often include protocols for traditional in-person activities such as getting an x-ray at an imaging center. However, digitization is still a key component to decentralized clinical trials. In fact, decentralization offers the perfect opportunity for traditional and virtual clinical trial sites to work together in the same study.
What are “traditional” clinical trial sites?
Common examples of traditional clinical trial sites are academic medical institutions or privately owned research centers with the capacity to have the entire study staff on-site. Structurally, the team consists primarily of a principal investigator (PI), responsible for implementing and overseeing the clinical protocol, and clinical research coordinators (CRCs), responsible for managing the day-to-day activities of the study. But, the key point here is that all trial staff are physically present at the site.
Before moving into the CRO and Pharma side of the industry, I started my career as a CRC at QPS-MRA (Miami Research Associates), and over my 10 years of working in traditional settings, I recognized pervasive challenges for patients, sponsors, and site staff across highly centralized clinical studies that could be solved by leveraging digital technologies.
One of the challenges faced by traditional trial sites is geographical limitations. It is common knowledge within the industry that patients are generally not willing to travel far outside of their region to participate in a trial, especially if it requires going into the site multiple times throughout the course of the study. This presents a barrier for patient access and engagement and limits the study team’s ability to enroll and retain sufficient participants.
The “virtual trial site” offers a solution to fill the gaps that are otherwise not accessible to traditional trial sites.
What are “virtual” clinical trial sites?
Virtual trial sites engage local, mobile, and telehealth providers to conduct clinical trial activities. They are managed by a remote-based PI who may oversee sub-investigators, mobile nurses, mobile phlebotomists, remote-based CRCs, and other study staff located across dispersed areas. Trial staff record study data and communicate using technology.
Virtual sites look different for different trials. For one study, a virtual site may constitute five community clinics in Houston overseen by one remote-based PI with remote-based CRCs, located across the United States, meeting with patients via telehealth to review and sign eConsent documents. For another study, a virtual site may be the entire state of Texas. The PI, located in Ontario, manages a team of mobile phlebotomists based in Houston, San Antonio, and Austin with CRCs assisting remotely from Orlando.
The key difference from traditional sites is that virtual sites have no central location for trial staff. This decentralized structure allows for different types of sites, remote-based and physical, which opens up more opportunity for patients to enroll and engage with physicians they otherwise would not have access to. Virtual sites are also beneficial for sponsors because increased participant enrollment and diversity is highly desirable to all stakeholders. Virtual sites are used to unlock geographic regions where we otherwise would not likely have been able to recruit and manage participants relying on traditional sites alone.
So, how can we use them simultaneously?
Can “traditional” and “virtual” clinical trial sites work together in the same study?
Well, virtual trial sites don’t exist in a vacuum. Most clinical studies require at least some in-person activities, whether at-home or in a clinical setting. But, one of the major benefits of virtual trial sites is that they can be added into any study alongside traditional trial sites.
Let’s take a look at some examples:
A pharmaceutical company is running a phase II clinical trial evaluating a new dermatological drug that is stable at room temperature. They are using two well-established academic medical centers in North Carolina but are having trouble recruiting participants who are a bit out of reach due to the limited geographical area. In order to extend the reach of these institutions, the protocol is revised to allow participants who live anywhere in North Carolina to participate from home through the use of remote-based CRCs, mobile phlebotomists, and home drug delivery. The two existing PIs, in addition to maintaining oversight of the staff at their physical locations, oversee the remote-based staff and interact with participants remotely through the use of robust technology solutions.
A diagnostic medical device manufacturer is running a US-based pivotal trial. The study activities do not present significant risks to the participants (i.e. primarily blood collection, medical records review, and long-term follow up with participants over a two year period). The company has contracted with a CRO and has activated 75 traditional sites; however, recruitment is slower than anticipated. Despite having a large number of sites, the CRO recognizes that a number of regions, particularly in rural areas, are not covered and they are having difficulty identifying interested and qualified sites in those regions. The CRO decides to supplement their existing sites by setting up 15 virtual sites in the underrepresented areas. Each virtual site is able to complete all study activities through the use of a regional, remote-based PI, CRCs, and mobile phlebotomist – supported by fit-for-purpose technology solutions.
A digital therapeutics company is preparing to run a pivotal trial for a digitally delivered cognitive behavioral therapy. Given the risk-profile of the intervention and the digital nature of both the therapeutic and the primary endpoints (i.e. clinical outcome assessments that can be captured electronically), the company decides to run a fully decentralized trial, meaning all interactions between participants and site staff will occur remotely. The company partners with vendor(s) capable of providing both the technology and remote site staff required to run the trial. Ultimately, 20 virtual sites are activated within strategic locations to best reach a diverse set of patients that fit the target patient profile.
The first scenario showcases how virtual trial sites can augment already existing traditional trial sites capabilities, while the second scenario showcases how virtual trial sites can work alongside traditional trial sites, and the third scenario demonstrates the ability for virtual sites to be the sole solution in limited circumstances.
So, yes, virtual and traditional sites can work together. In fact, they are working together already on a number of trials. Through the various hybrid models available, we can recruit and retain a greater number of participants, ensure a more diverse and representative study population, and ultimately help bring safe and effective treatments to patients more quickly.
This article was originally published on The Curebase Blog and is republished here with permission.