All-digital clinical trial demonstrates the feasibility of siteless studies
Trial compliance in the VISITOR (VIrtual, SIteless, Technology Open Research) study was reported to be high, and participants also stated high levels of satisfaction with the overall study experience, according to the company. Patients consented to the trial via video and provided data through any of their computing devices with a web browser using the company’s digital study hub, Transparency Virtual Trials.
A spokesperson for Transparency Life Sciences (TLS) told us, “The Transparency Virtual Trials hub is designed to be flexible and can integrate point solutions developed by a wide variety of industry-leading technology partners.”
The company stated that, to its knowledge, this study is the first-ever clinical trial to integrate visit scheduling, participant screening, remote consent, and telemedicine, collecting safety and efficacy variables through mobile device and data management technologies.
The VISITOR study was comprised of healthy volunteers to assess the feasibility of capturing clinical data from subjects using widely -available mobile technology. Efficacy was measured through an assessment of the participant's experiences during the virtual study visits, as well as the data captured, and the suitability of the methodology for the implementation in clinical research.
Data collected in the study included standard variables such as vital signs and a single-lead EKG as an efficacy variable.
“Participant feedback was a key element of the study,” the spokesperson said, explaining that participants were asked to respond to structured feedback surveys as a form of electronic patient-reported outcome (ePRO). At the end of the study, responses were analyzed and quantified across multiple categories to provide systematic assessments of participants’ experience.
According to Tomasz Sablinksi, co-founder of TLS, Transparency Virtual Trials is now ready to be scaled to collect global data, accommodating both wearable and hand-held devices to make virtual siteless trials more feasible.
“In addition to testing the accuracy and reliability of direct-to-patient data-collection devices, a major area of investigation was quantifying participants’ level of trust in the virtual visit process. We found strong support across all demographics in terms of participants feeling comfortable generating clinical data using the digital devices themselves in the privacy and comfort of their homes,” said the TLS spokesperson.