There is a lot of discussion surrounding the introduction of virtual platforms into the clinical trial space and pharmaceutical sponsors are taking various approaches. As a result, these varying solutions provide different experiences for everyone involved. The following Q&A discusses the hybrid approach taken by Virtrial and how it aims to best serve all involved parties: sponsors, trial sites, and patients.
Kim Kundert is VP of Operations at Virtrial and the former Sr. VP of Operations at Radiant/Synexus US, where she was responsible for clinical operations for the largest site network in the US consisting of more than 85 sites. Kim has 20 years of site knowledge being involved in more than 12,000 trials and enrolling hundreds of thousands of patients.
Q. What challenges did you encounter while operating trial sites that led you to support the rise of virtual platforms for clinical trials?
It was a common scenario that we would find a perfectly qualified patient that met all trial criteria, yet they would decline participation because of the frequency of site visits required. When we explained the visit schedule, they would realize that they would be on vacation during a required visit time, or they might be a snowbird and be gone for months at a time. That was one of the biggest impediments to signing up trial patients.
By introducing virtual visits, we enable more patients to participate. It allows them to work around their personal schedules and still contribute to trial studies.
With streamlined access to site personnel, virtual visits also increase retention rates. Traditionally, we would see dropout rates increase over time, especially with longer trials. Perhaps someone’s boss initially agreed to allow the patient to leave work to visit the site on a regular basis, but over time changes his/her mind. Other common life events also get in the way – the kids get sick, the travel becomes a burden, etc. Virtual visits eliminate all of these issues and enable patients to participate in the trial regardless.
Q. How does a virtual trial platform address those challenges?
By allowing certain visits to be conducted at the patient’s home or work, participation becomes much easier. For a typical 12-month trial, a patient’s commitment to travel to the site may drop from four times during the year to only one. This allows them to carry on with their busy life and still participate. They don’t have to choose one or the other because virtual visits take the burden off them and gives them flexibility. As a result, it also enables pharmaceutical sponsors to complete trials faster.
Q. Are there specific scenarios or types of trials that are best suited for virtual trials?
A perfect scenario is a Phase 4 post-approval trial. Those trials may last three or four years so it can seem like a pretty heavy commitment for patients to make. However, if they only need to physically go to the site once a year for a physical, lab work, and to obtain medication, that becomes much more realistic. This hybrid approach to clinical trials adds convenience for patients, simplifies the process for trial sites, and shortens cycles for sponsors.
Phase 3 trials are also great candidates for hybrid virtual trials. Substituting virtual visits for physical appointments is a perfect solution for interim visits where a coordinator is only checking compliance and not a lot is needed at the site level.
A Hybrid Approach to Clinical Trials
Q. What exactly do you mean by a hybrid approach?
Many clinical trials require one or more physical visits to a clinical site. It is often imperative that patients are seen in person for certain activities like confirmation of diagnosis and study eligibility, physical exams, and dispensing of study medication. Due to these stipulations, it is often not possible to conduct a trial 100% virtually. We envision 25% – 50% of physical visits being replaced by virtual visits to make the virtual approach more realistic and applicable for more trials.
Q. Why do you believe a hybrid model is important?
Technology is not yet where it needs to be for 100% interventional virtual trials. While the development of apps to collect vital signs, ECGs and patient physical activity are becoming available they are not yet mainstream in trials. Also, telemedicine is not yet advanced enough to replace an in-person physical exam and aid the physician in diagnosing the patient via video. Until this happens, in-person visits will still need to take place to ensure patient safety and data integrity.
Q. What sets Virtrial apart from other virtual trial providers
Virtrial was built based on many years of experience operating clinical sites and running thousands of trials. Our solution offers several benefits not just for patients but also for the sites and pharmaceutical sponsors.
Virtrial can be used on any device including participants’ personal devices, (Apple, Android, tablet, smart phone, desktop) eliminating the sponsors’ expense of purchasing standard devices for each patient. Using a BYOD (bring your own device) model allows patients to use a device they are comfortable with and makes it easier for sites to train patients on the app. Conducting virtual trials with patients’ personal devices also means it’s possible to contact them 2 – 5 years later to fully assess safety effects in a real-world setting for longer post-approval trials, as is now being recommended by the FDA.
Our platform allows for up to 4-way calling and has the built-in ability to pull in interpreters with the click of a button. We provide translation for 20 languages via video and 183 via audio. Virtrial will soon have API integrations with numerous related technologies such as electronic diaries, electronic questionnaires, wearables and more so that sponsors get their information in one package vs. separate packages from multiple vendors.
Virtrial is flexible and enables pharmaceutical companies to run hybrid virtual trials using their preferred clinical networks. The platform is available for use at any site and Virtrial provides the training for clinical site staff.
Q. How can big pharma sponsors and clinical sites be confident that Virtrial is reliable, scalable, and secure?
Virtrial is built on the proven Stratus Video and Synzi telehealth platform which won the 2018 Medtech breakthrough award for virtual care innovation. The platform has been in use for the past eight years and is being used in over 1700 hospitals, conducting 100,000 virtual visits per day. It is hosted in a secure, cloud-based environment that is HIPAA compliant.
Additionally, the platform is designed so that sponsors can customize communications per protocol, per visit, or at the site level. For example, it can be set up to send a general message to every patient to remind them to click on the provided link when it’s time for an appointment, or a site can set up individual patient reminders for those that are at risk of non-compliance. The framework is available to customize as needed.
Q. What do you hope to accomplish with Virtrial?
Our company vision is to increase overall enrollment statistics for patients participating in clinical trials. Having been involved with so many trials over the years, I know how beneficial virtual visits will be for patients. I’m confident that the added convenience of virtual visits will cause the number of participants to go up as well as retention rates. And if we can increase retention in trials it will help the whole industry.
Our goal with the platform is to make the technology easy for patients to use and also easy for sites to use. Clinical sites are busy seeing patients and collecting information. Any new solution has to be simple and intuitive for the site to use or else we’re adding to their burden. Of course, the ultimate goal with all of this is getting new medications to market faster.
Q. How can a pharma sponsor connect with Virtrial to get more information and see a demo?
Contact us and request a demo. We customize every demo to suit your needs and can show any capability you want to see. If you’re interested in incorporating virtual trials into an upcoming trial, or an ongoing trial that isn’t going as planned, we can work with you to implement a virtual hybrid solution to improve enrollment and retention.