The US Food and Drug Administration (FDA) has granted approval to Transparency Life Sciences (TLS) to conduct a study of the effects of a blood pressure drug on patients by using a remote monitoring service.
Researchers will collect data directly from patients in their homes equipped with tablets via 3G or 4G, so removing the need for frequent visits to a study site. Those outside cellular coverage will need to use a fixed connection.
Some media reports have described this as being the first time such an approval has been given but the FDA has approved other trials which featured a small component of remote monitoring.
But its backers say this is the first time approval has been given for a trial collecting such a broad range of data.
The remote monitoring element of the study is supplied by vendor AMC Health. “Pharmaceutical companies have been worried that the FDA would not accept telemonitoring in place of costly clinic visits,” said John Holland, SVP for research and business development at AMC Health.
In the 12-month trial, patients will see clinical trial staff twice. Between visits, all other data will be gathered from patients’ homes. Secure mobile video will also be available for contact between patients and researchers.
AMC Health does not specify whether the data is gathered from patients’ home via a broadband or mobile connection. Or whether they will be issued with a custom-built smartphones or tablets for the video conversations.
Generally, there is a growing interest in using mobile technology in drug trials. For instance, last year Vodafone and specialist firm Exco Intouch agreed to work together on a service that enables pharmaceutical companies and research organisations to more-effectively collect data from participants’ mobile phones during clinical trials.
TLS’s Phase 2 trial will help test a drug called Lisinopril. Unlike the $5-10 million that such a study typically costs, TLS expects the cost of the trial to be about $1.5 million “with the bulk of the savings reflecting the use of AMC Health’s telemonitoring resources”.