The FDA awarded biopharmaceutical company Transparency Life Sciences (TLS) Investigational New Drug status for their innovative clinical trial design. The design of this Phase 2a remote monitoring trial—the first of its kind—will rely heavily on data collected from participants’ homes and will include vital sign monitoring and secure video interaction between subjects and researchers through the telemonitoring company AMC Health.
Researchers plan to enroll 180 MS subjects into this telehealth initiative and evaluate the safety and efficacy of blood pressure drug lisinopril in the treatment of MS. The investigators are hopeful that this new type of trial design will effectively eliminate the kind of researcher bias that can occur with the collection of data in the clinical setting. In addition, AMC Health estimates that by using remote technologies and crowd sourcing, TLS can conduct the trial for $3.5 million less than the cost of a traditional Phase 2a trial.
“FDA approval of this innovative study design is a significant milestone,” noted John Holland, senior vice president for research and business development at AMC Health. He said mobile video interactions over the 12-month study period will “increase quality and quantity of data, and reduce the burden on patients.”