Clinical studies are carefully designed to address the unique needs of not only the sponsor, but more importantly, the patients that commit to participate. Depending on the nature and severity of the condition, study lengths vary. A cardiovascular outcome trial (CVOT), for example, requires a long duration (potentially up to five years) in order to effectively evaluate real-life, long-term outcomes. This long-term commitment from participants tends to lead to an increase in dropout rates over time. It is widely documented that participants often get bored or distracted before the trial completes.
Reducing those dropout rates, as well as ‘lost to follow up’ patients, is a key consideration in ensuring statistical significance of long term trials. It can be very expensive and time consuming for both sponsors and sites to track patients down when they fail to comply. Providing flexibility for participants is one way to help limit dropouts, especially for those that want to comply but are unable to travel to the site for check-ins. Early indicators show that introducing a flexible telemedicine platform for remote visits adds patient convenience and facilitates ongoing engagement, trust, and communication. The technology enables patients to stay connected regardless of where they move or travel.
How Hybrid Decentralized Clinical Trials (DCTs) Improve Outcomes
Convenient for Patients
The increased access and scheduling flexibility available within telemedicine platforms gives patients more control. By using a telemedicine platform, they can communicate via secure chat, email, or video and have the ability to take virtual visits from anywhere. The VirTrial Virtual Care Management (VCM) platform works on any device, including patients’ personal devices so patients do not need to be tech-savvy. Any necessary training can be done virtually.
Patients are often more engaged in the study when using a telemedicine platform since they can easily receive periodic communications (e.g., diet and exercise counseling). The app enables patients to receive reminders on study procedures throughout the trial and quickly alert site staff of changes outside of the visit window. This additional flexibility is especially effective when patients can continue their care with the same trusted physician with whom they’ve already established rapport.
Efficient for Sites
Introducing remote visits to study protocol provides sites with a tool to stay connected to patients more regularly throughout the duration of the study with less effort. Telemedicine platforms designed specifically for clinical studies follow a site’s workflow and streamline their processes. Options to set up and automate messages keeps the study requirements front and center of patients’ minds and eliminates hours of manual administrative work for site staff. VirTrial’s VCM works on any device (Android, Apple, phone, tablet, computer) including patients’ personal devices so that sites have no special phones to store or train on.
If your site struggles with enrollment and spends excessive time screening patients in the office only to find they are not qualified, a VCM platform can simplify that process as well. Virtual pre-screenings require less commitment from the patient, allow the site to pre-qualify a patient face to face remotely, and bring only those patients who are likely to enroll into the clinic. This results in reduced no shows, as well as reduced onsite screen fail rate, reducing the burden on both the patient and the site.
Easy on the Budget
Retaining patients is critical for ensuring statistical significance of a study, and of course, is less expensive than recruiting new patients. Simplifying the process for those that aren’t able or willing to travel on a regular basis increases the likelihood they will participate through the duration of the study and reduces sponsor costs by eliminating the need to pay a stipend for patient travel.
Because VirTrial’s VCM platform works on any device, there is no need to purchase or store a supply of specific devices for remote visits. When patients are using their own devices, you always have a method to contact them, which limits the need to pay third parties to track down patients who disappear during the trial.
Additionally, virtual pre-screenings can save a significant amount of money and reduce on-site screen failures for new studies by eliminating the need for potential participants to travel to the site in person.
VirTrial’s VCM platform works with any clinical site worldwide enabling pharmaceutical sponsors, CROs, and sites to maintain control over clinical studies and save time and money getting better medications to market more quickly. Contact us for more information on incorporating remote visits into your studies.