AMC Health will offer an array of telemonitoring services for clinical trial of lisinopril, which will be conducted by Transparency Life Sciences (TLS).
US FDA has granted Investigational New Drug (IND) status to Lisinopril, which allows TLS to conduct phase 2a study to know the effects of the drug, used to treat blood pressure in multiple sclerosis (MS) patients.
AMC Health, in partnership with TLS, will provide telemonitoring technologies, enabling researchers to collect data on blood pressure and heart rate, mobility, physical and mental function, symptoms, side effects, quality of life and medication adherence, directly from patients in their homes avoiding the frequent physical presence at the study site.
AMC Health research and business development senior vice president John Holland said,''Pharmaceutical companies have been worried that the FDA would not accept telemonitoring in place of costly clinic visits."
"Frequent data collection at home is also expected to increase patient safety, because if a side effect were to appear, researchers will know about it sooner, without having to wait for the next study visit," Holland added.
TLS expects to bring down the 12-month trial costs to nearly $1.5m, from an estimated costs between $5-$10m by using AMC Health's telemonitoring resources.
Patients will be required to be present in person only twice during the total trial period, according to AMC Health.
