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Transparency Life Sciences (TLS), an all-digital drug development services company, announced the successful completion of its VISITOR (VIrtual, SIteless, Technology Open Research) clinical trial. VISITOR was designed to assess the feasibility and ease, along with the quality and integrity, of collecting research-grade clinical data directly from subjects in their homes or offices using the Transparency Virtual Trials (TVT) digital study hub.
The study demonstrated that participants were quickly able to adapt to using telemedicine devices to capture data commonly collected in clinical trials. Compliance in completing the virtual study visits was very high, and participants reported high levels of satisfaction with the overall study experience. The study demonstrated excellent levels of data integrity and accuracy, with a negligible number of missing data points. Detailed study results will be described in a future peer-reviewed scientific publication or presentation.
TLS co-founder and CEO, Tomasz Sablinski, MD, PhD, commented, “To our knowledge VISITOR is the first-ever clinical study integrating visit scheduling, participant screening, teleconsent, telemedicine, and collection of safety and efficacy variables via mobile device and data management technologies. We are very encouraged by the success of this study, which confirms that our virtual trial approach is feasible, accurate and well-received by participants.”
Dr. Sablinski added, “At TLS, we are putting patients at the center of the clinical research enterprise and reducing the burden of participation. Clinical trial sponsors benefit from greater patient engagement and retention, more representative study populations, and simplified and enhanced data capture. Our TVT platform is now ready to scale to collect data globally, accommodating a variety of wearable or hand-held devices and making virtual site-less trials possible across many therapeutic areas. We are currently collaborating with a number of sponsors interested in increasing the productivity of their development portfolios by fielding all-digital and hybrid clinical trials using our Transparency Virtual Trials platform.”
The VISITOR study enrolled healthy volunteers to assess the feasibility of capturing clinical data from subjects at home using TLS proprietary systems and widely available mobile technology. The primary efficacy outcome measure was an assessment of participants’ experiences during the virtual study visits. Other objectives included assessments of the completeness of data captured and suitability of the methodology for implementation in clinical research.
VISITOR did not include an experimental treatment, but it collected a number of standard data variables measured in all clinical trials, including vital signs such as blood pressure, heart rate and body weight. In addition, single-lead EKG was monitored as a safety variable and pulmonary function tests were performed as an efficacy variable, using a mobile spirometer. These pulmonary function tests are standard primary or secondary endpoints in clinical trials for lung diseases.
For more information about Transparency Virtual Trials, contact Emily Tabacchi at: firstname.lastname@example.org