Udani said the primary benefits of the new approach toward conducting clinical trials makes for faster enrollment, better engagement with subjects and significant cost savings. The Agoura Hills, CA-based contract research organization uses patented mobile application technologies rather than in-clinic visits to work with subjects. The approach combines mobile apps and virtual telemedicine with specialized teams of experts remotely monitoring all of activities related to the study.
Udani said the approach can significantly improve compliance and the quality of the data.
“The vast majority of studies are based on patient-reported outcomes. In that case the data generated by the mobile approach is the most meaningful because it is gathered in real time and there is an audit trail around that,” Udani told NutraIngredients-USA.
Data from subjects is gathered via blood spot tests, in home devices such as blood pressure cuffs, digital scales and so forth. Study subjects record the images or in some cases the data is loaded directly. And there is an audit trail around making sure subjects are remaining in compliance with dosage requirements, Udani said.
“There is a video record of the patients taking the product with a time stamp on it,” Udani said.
The approach helps with compliance because the participation of subjects in the study is managed in real time by Medicus employees. If a subject is drifting out of compliance, it is immediately apparent, Udani said.
“If you have not uploaded data for two days in a row you will get a an e-mail, a text message or a call from a real person. It is remarkably more efficient, more cost effective, faster and more engaging for the subjects,” Udani said.
Better representation
In standard research studies, the selection of study subjects is generally limited to a certain travel radius around a given research center. Using the smartphone approach, subjects can be recruited from anywhere. While Udani admitted that limits the potential reach to those subjects who have smartphones and are comfortable using them, that now applies to a growing majority of the US population. And those type of potential research subjects tend to be the kind of people who buy dietary supplements anyway, Udani said.
In addition to the increased reach, the technology means subjects can be recruited much more rapidly, getting a study up and running quickly. And part of the cost savings come in with lower stipends offered to study participants.
Lower costs equals more research
Udani said he hopes that the lower cost threshold means more meaningful research can be done on dietary supplements. He estimates the overall cost savings of the mobile app studies is about 40% over conventional methods. Companies that already conduct studies can consider adding subjects to increase the statistical power of a study. And it could mean that companies that were previously priced out of the market could now contemplate conducting their own research.
“Industry needs clinical studies with real outcomes in real world settings,” Udani said. “Using this technology, you are starting with studies that have a high enough sample size at price ranges well within many companies in the industry.”
Udani said his company has been asked to make a guest presentation of the technology to FDA. The agency is considering using it for pharmaceutical trials, he said.