FDA Green Lights Mobile Monitoring for Drug Trial

FDA Green Lights Mobile Monitoring for Drug Trial   The U.S. Food & Drug Administration MS mobile monitoring mHealth Lisinopril FDA AMC Health The U.S. Food & Drug Administration is standing behind the pervasive force of mobile in all aspects of contemporary medicine.

As a result, the FDA is backing a new effort described as a first-of-its-kind remote monitoring trial for a blood pressure drug.

The underlying goal of the trial, however, is to learn more about the effectiveness of the blood pressure drug in question -  Lisinopril – on multiple sclerosis patients.

Remote monitoring for the trial will accompany the 12-month study as data is collected from 180 participants. The patients will remain in their homes and wear monitors that collect vital signs. Video interactions will also play a role in the trial.

The remote monitoring is made possible by mobile technologies and is said to substantially decrease the cost of the entire study. AMC Health will provide a broad array of telemonitoring services necessary for the venture.

In this 12-month study, patients will see clinical trial personnel only twice.

“FDA approval of this innovative study design is a significant milestone. Pharmaceutical companies have been worried that the FDA would not accept telemonitoring in place of costly clinic visits,” says John Holland, senior vice president for research and business development at AMC Health.

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