LOS ANGELES—Medicus Research introduced its Virtual Research Clinic, which defines a new standard for how studies can be performed better, faster and cheaper.
Combining mobile apps and virtual telemedicine, virtual research studies provide many benefits, including faster enrollment, better interaction with participants, superior compliance, more reliable data and cost savings.
Recruitment time has been considerably decreased because potential enrollees don’t need to live within close proximity of a clinic. Recruitment can be done anywhere, at anytime, and screening happens rapidly. With the Virtual Clinic, the study can start more quickly.
Once remotely screened and enrolled, various data from subjects can be gathered through mobile apps, devices in the home (such as blood pressure cuffs and digital scales), or blood spot tests. If needed, the Virtual Clinic sets up remote integration with regional labs for more comprehensive blood testing.
Data is collected in real time from study participants (patient-reported outcomes) and a complete audit trail is provided of user activity across all systems. Ensuring their compliance, subjects are video recorded through the study app while taking the investigational product and fulfilling other requirements of the study protocol. All activities are time/date stamped.
If a subject has not used the app for two days in a row, they get an email, text or call from the monitoring team. In a traditional clinical trial, it is not known if a participant is noncompliant until his or her next in-clinic visit, and even then, daily paper diaries can be fabricated.
By reporting daily through their own smartphones, subjects feel more involved in the study and show better compliance, leading to more accurate study results.
The Virtual Research Clinic is the association of many different specialized teams working together to recruit study subjects, monitor their compliance in real time and analyze the data that streams into the Virtual Clinic daily.
Medicus Research has already performed more than 20 remote studies successfully, proving the virtual system not only works, but is superior to traditional clinical trials in many respects.
As a case in point, participants in the Medicus remote study for the popular Dukan Diet were required to download the study’s eCompliance App. Compliance was positively impacted when compared with traditional studies of a similar nature. Subjects participating in the virtual Dukan Diet study were documented to be 87 percent compliant. Average compliance rates for in-clinic weight loss trials are between 40 and 60 percent. Study results were recently presented at the 55th Annual American College of Nutrition Conference.
Medicus Research was the first CRO to publish results of a remote clinical trial for Natural Health products: "High Potency Fish Oil Supplement Improves Omega-3 Fatty Acid Status in Healthy Adults: An Open Label Study Using a Web-Based, Virtual Platform," which was published in the Nutrition Journal (Nutritional Journal, Aug. 2013).
Most recently, Medicus Research was invited to present its Virtual Remote Clinical Trial System to FDA.
Last year, the company also launched a new mobile application product for the dietary supplement industry: Wellness Apps.