FDA approves first remote monitoring drug trial

Tools

The U.S. Food & Drug Administration recently approved its first remote monitoring trial, a 12-month Phase 2a study by biopharmaceutical startup Transparency Life Sciences, according to an article posted by MedCity News. In the trial, multiple sclerosis patients will take the blood pressure drug lisinopril and wear vital sign monitors provided by New York-based telemonitoring company AMC Health.

The trial will include 180 subjects, and those with wearable vital sign monitors will transmit their data to investigators and also conduct secure video conferences with them. Researchers will 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, eliminating the need for frequent visits to a study site.

As a result, AMC Health's remote monitoring technologies will dramatically reduce the cost of the study to just $1.5 million. The trial is estimated to save $3.5 million over a traditional Phase 2a study, which can cost upward of $5 million AMC Senior Vice President for Research and Business Development John Holland tells MedCity News.

Patients will see clinical trial personnel twice over the course of the year-long study, according to an AMC Health announcement. In between those visits, all other study data will be collected from patients' homes. Secure mobile video visits will enable researchers and patients to see and talk with one another during the trial.

The study will help determine whether lisinopril is safe and has promise in the treatment of MS, and could lead to a follow-on Phase 3 efficacy trial. AMC Health also is providing telemonitoring services for a Phase 1 study of a new drug conducted by a major pharmaceutical company.

Last year, Danville, Pa.-based Geisinger Health Plan used a home telemonitoring program for patients with congestive heart failure that reduced their readmission rate by 44 percent, compared to a control group. The success of the telehealth program, which incorporated technology from AMC Health, has prompted Geisinger to expand those efforts to include patients with hypertension and diabetes.

To learn more:
- read the MedCity News article
- read the AMC Health announcement

Related Articles:
Few physicians refer patients to clinical trials
Terminal cancer patients may benefit from phase 1 trials
Study: Journal articles about drug trials missing or incorrect