New MS Drug Trial Will Rely on Remote Patient Telemonitoring

Published Online: Thursday, February 14, 2013
Follow Pharmacy_Times:
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.”

Related Articles
Rite Aid has announced the opening of HealthSpot stations inside 25 Rite Aid pharmacies in Ohio.
Walgreens, in collaboration with MDLIVE, the nation’s leading provider of telehealth services, today announced an expansion of its telehealth platform to users in Colorado, Illinois and Washington.
Despite an unprecedented boom in using technology to provide health care, telemedicine remains the red-headed stepchild of the industry.
Walgreens today introduced a new telehealth offering that will give Walgreens website users 24/7 access to U.S. board-certified doctors through its mobile application. With today’s launch, the service is now available to users in California and Michigan, with plans to rollout to additional states and markets over time.
Latest Issues
$auto_registration$