Lee Horner

	Pharmaceutical companies, large health systems, contract research organizations, and clinical trial agencies may be initially hesitant to incorporate virtual care in their study, as they are of any tool or technology that may require them to approach the design and execution of clinical trials in a different manner. However, new applications of technology are revealing a totally new value proposition that could rapidly accelerate the use of virtual care across clinical trials.  

	Virtual care technology is emerging as a valuable tool for clinical trials, helping to improve recruiting and strengthen retention while optimizing resources for the overall study. By using a virtual care platform, coordinators can conduct video interviews with potential study participants across multiple geographies. Once enrolled in a study, trial participants can receive pre-scheduled text or email reminders regarding upcoming appointments. During the study, coordinators and investigators can conduct convenient and timely virtual visits-essentially video check-ins-with patients to improve compliance, address emerging issues, and reduce dropout. Real-time virtual visits can reduce the number of trial sites needed and the related costs for trial participants and research team members.

	The technology platform can operate across commodity devices (e.g., laptops, smartphones, or tablets) which the research team and the patient likely already own. Planned communications-such as inviting a patient to participate in the initial screening process-can be scheduled and sent via email or text. Study participants will then have an opportunity to indicate if they want to receive ongoing appointment reminders via email and/or text. When a participant is required to check-in for a virtual visit, the virtual care platform can send the patient a text and/or email message with a request to launch a video call within a specified amount of time. By clicking on the request (on a laptop, smartphone, or tablet), the study participant can initiate the video call with a coordinator from anywhere and on any device. When prompted, the coordinator will accept the video call request and likely conduct the call on his/her laptop. If a study participant raises an unexpected side effect, a coordinator can also use the virtual care platform to quickly include an investigator in the video call. After receiving a notification to join the conversation, the investigator can communicate (verbally and visually) with the coordinator and the patient to better understand the situation. And, if a specialist is needed, the investigator can also reach out to a specialist to join the virtual visit. The virtual care platform can be configured to include contact information, scheduled availability and communication preferences for all stakeholders.

	Improve Recruiting
	Patients may be hesitant to enroll in a clinical trial, given the travel time needed to reach faraway study sites. Additional barriers may include the patient’s physical limitations due to age or health reasons, as well as the patient’s language preference or health literacy levels. With virtual care technology, trial coordinators can use video communications to simplify the screening process. Suitable study participants will not need to travel to a research site for the initial screening visit. As needed, an interpreter can be integrated into the initial screening appointment and can also be included in ongoing virtual visits. A virtual interview is more efficient from a timing standpoint and effective from a resource perspective.

	Strengthen Retention
	Patients can experience challenges in trying to remain in a study. Participants may drop out of a study due to the extensive travel time required for in-person appointments and assessments-in addition to the time spent away from family, work, school, etc. High rates of drop-outs may lead to insufficient data points and ultimately, a failed clinical trial. With virtual care technology, a research team can use video communications to enable study participants to conveniently check in with the trial coordinators and investigators, all from the comfort of their home. As needed, a specialist or pharmacist can also be integrated into the virtual visit to address the patient’s immediate concerns, emerging issues, and potential side effects in real-time; the research team can then determine if these issues impact the patient’s eligibility and outcomes. Virtual visits can drive enhanced retention and greater satisfaction amongst the participants, their caregivers, as well as the research coordinators and investigators.

	Optimize Resources
	The economics typically involved with clinical trials are quite steep; most studies maintain multiple trial sites, coordinators, and investigators dispersed across the nation or around the globe. With virtual care technology, an organization can use video communications to support a centralized trial, with a core team operating virtually with each other and with the study participants. The number of trial sites can be minimized, along with the costs for launching and maintaining the site. The number of study team members can also be minimized, along with the costs associated with their involvement. The number (and related expenses) of the research teams’ visits to multiple trial sites can also be reduced since the teams can communicate virtually throughout the course of the study.

	Virtual care technology has many viable applications for clinical trials, including strengthening recruiting and retention of participants and minimizing overall study sites, personnel, and related costs. With a virtual care platform, research studies can better identify and engage participants across the US and the globe, helping to improve compliance, reduce drop-out rates, and strengthen the needed data points.

Articles

Virtual care technology is emerging as a valuable tool for clinical trials, helping to improve recruiting and strengthen retention while optimizing resources for the overall study.

Lee Horner

Articles

Value of Virtual Care Technology in Clinical Trials