The evolution of clinical research and the emergence of virtual trials introduces new models, processes, and terminology into what has been a fairly static industry for at least the last decade. As with most new technologies, virtual trials are available from multiple providers offering varying solutions and differing approaches. As such, understanding the industry jargon is critical in understanding the differences in the offerings and making the right choice for your organization.
The proposition of a ‘decentralized model’ has been getting attention lately, yet there is a lot of confusion about what that actually means and how it may or may not be beneficial to sponsors, sites, and patients. In fact, the notion of a decentralized model is a bit counter-intuitive on the surface, so let’s look at an example.
The Decentralized Model
The term decentralized sounds like it would create a wide-spread geographic swath of research sites to facilitate a more diverse group of participants. In fact, it is the opposite. Science 37, the most aggressive promoter of a decentralized model, has created what it calls a ‘metasite’ which is essentially a large conglomerate of clinical staff in one single location. This metasite acts as a central hub for all their trials.
If a sponsor wants to use a network of research sites they’ve worked with on previous trials, it is not possible with Science 37. The sponsor’s only option is to work through the metasite with an assigned Principal Investigator who is employed by Science 37. Because the Science 37 model is 100 percent virtual, participants do not have to be in a central geographic region, yet their research staff is one centralized group.
The Principal Investigator (PI) and team at the metasite oversee the trials virtually from start to finish. Patients go to a website to enroll and complete online questions to determine if they qualify. If they pass, they complete a remote consent form and enroll themselves. Science 37 then sends everything in a box to the patients’ addresses and all visits are conducted via video.
This ‘decentralized model’ aims to eliminate the reliance on independent research sites by creating ‘site-less’ trials. This approach also means that all study results are compiled and reported by a single entity vs. a community of diverse clinical research professionals from various regions and backgrounds.
A Hybrid Approach
By comparison, a hybrid approach to virtual trials take a more measured approach to introducing virtual trials into the clinical research industry. VirTrial’s vision for a hybrid approach is to enhance the traditional clinical trial process by adding to it the capacity to conduct 25 – 40 percent of visits virtually while still allowing patients the intrinsic value of human interaction. The option adds flexibility and reduces the burden on patients by reducing the number of times they need to travel to the site for in person visits.
A hybrid approach establishes and maintains a human connection and provides access to a physician via in-person visit when needed or wanted. It ensures that the patient meets all qualifications, understands their risks, and is properly trained on the telehealth platform via fact-to-face meeting at the onset of the trial.
Enabling optional virtual visits during trials gives patients more control, increases retention, and improves efficiency for all parties involved. It also ensures objectivity and validity of the trial by maintaining a diverse group of PIs who can apply their experience and share first-hand observations.
It’s important not to lose sight of the purpose of new technology. It should be applied thoughtfully to enhance current operations, improve safety, and support responsible clinical research. Virtual trial implementation should not be based solely on efficiency and cost-savings, but rather on what is best for the industry overall.
Time will tell whether patients prefer a 100 percent virtual experience with no option for face-to-face human connection or whether they prefer the option to see their physician in person as well as virtually. Early attempts at a site-less trial have shown extremely poor retention rates. In one study by GlaxoSmithKline, only 50 patients remained out of an initial 400+ that consented to participate after 12 weeks,* so our guess is that most patients will want to have a choice.