Virtual clinical trials can be considered more patient-centric than traditional trials, since modern technology enables patients to participate remotely, cutting down on transportation time and costs. But virtual trials create new challenges for patient recruitment and retention since they alter or limit what clinical trial participants say they value most: clear communications.
Patients in one survey said they value clear study communications 62% more than telemedicine options. That survey, conducted by Continuum Clinical and consultancy ZS, found patients consistently ranked the value of clear communication—especially details about their responsibilities and potential side effects—above all other trial elements, including free medical care, 24-hour support, medication delivery, free transportation, and wearable devices.
By their very nature, virtual trials limit or alter the kind of in-person communications that are so often important in a patient’s decision to enroll in a clinical trial. Successfully recruiting and retaining patients for virtual trials, then, will largely depend on developing virtual study communications to educate and empower patients while enhancing their understanding of the trial.
Virtually Replicating In-Person Interaction
In-person interaction naturally builds trust between patients and site staff. This is particularly important prior to enrollment, when the study coordinator explains the trial to the patient by having an empathetic conversation, where both the patient and study staff can read and respond to body language, ask and answer questions in real-time, and establish a trusting relationship. While the high-value relationships built with in-person interactions can never be fully replicated, they must be approximated as closely as possible. Virtual study communications and corresponding technology must be designed to replace these important connections between patients and the study staff, while offering a mechanism to enable patients to ask questions and receive answers real-time.
Virtual Welcome
Trial introduction letters and welcome books can be replaced with videos to communicate critical information once a patient is randomized. Video communication must be clear, patient-friendly, and educational, with a conversational tone and personalized messaging when possible. These videos will allow patients to digest study information as if they were talking with a site coordinator, while also introducing the virtual elements a patient will use throughout the duration of the trial.
Patient Support Resources
“How-To” video guides that clearly explain the virtual technology used throughout the trial, like an app and/or video conferencing software, will be vital to ensuring patients are comfortable with trial requirements. To supplement the “How-To” video guide, a troubleshooting video should be developed and made available to assist patients with technical issues. Incorporating these videos together with other study communications in a digital patient resource center will ensure patients stay connected and compliant throughout the study.
Digital Study Application
A virtual study app can replace paper study schedules and will help patients keep track of study appointments while ensuring they stay digitally connected with the trial. The study app can also record patient progress as they complete the trial. To signify completed study visits, award-style graphics representing the patient’s achievement will help to keep patients engaged throughout the duration of the trial. The study app should also encourage patients to voice concerns and may prompt patients to ask questions during their virtual study visits, recreating the back-and-forth that naturally happens during in-person study visits.
Virtual Study Communication Advantages
The development of virtual study communications in advance of a trial offers significant advantages to both sponsors and site staff. Sponsors will have greater control over trial communication, since they can ensure every patient receives the same clear and consistent messaging from enrollment to completion. Virtual study communications will also dramatically reduce the amount of time site staff typically spend with patients, minimizing site burden and allowing site staff to focus more time on other critical aspects of the trial.
As more clinical trials implement virtual elements into their design, patients will experience less in-person interaction and will lose the ability to form high-value relationships with site staff. An effective virtual trial will utilize technology not only as a tool to conduct the trial, but as a tool that provides patients with the clear communication they ask for and value.
