How can wearable devices benefit clinical trials?

The wearable device trend is popular among those who wish to manage their own health. With the help of a bracelet, smartwatch, mobile application or other gadget, patients can stay informed about various factors that contribute to their overall health. However, these devices can be used in more formal settings as well. Each wearable device collects a plethora of data from the individual sporting it, which makes it an ideal tool for clinical trials.

Wearables cut costs, improve data
The healthcare market is regularly teeming with new medications claiming to be the best treatment for one condition or another. However, how can one be sure of those assertions before these drugs hit the shelves?

"Wearables could detect issues early on to prevent extra costs or health concerns."

Any medical device or treatment goes through clinical trials to ensure its effectiveness before being sent to the United States Food and Drug Administration for approval, which can cost more than $2.5 billion per medication, according to Venture Beat. This cost includes various versions of the drug during development, along with testing and certification. That doesn't include the price of pharmaceutical marketing that will need to be done once it gets through the FDA. Clinical research organizations and medical companies will require more funding for that.

With the high costs CROs and their sponsors face, they are looking for ways to save money while boosting medical safety and effectiveness. Wearable devices may be the solution they're looking for. This technology could detect issues early in the study to prevent extra costs or health concerns, InformationWeek claimed. People's safety would be ensured and pharmaceutical companies could alter their treatments before they get too far into the research.

Because they collect an abundance of data, these gadgets could provide insight into various health conditions while patients participate in clinical trials, PharmaVOICE explained. With the help of business intelligence and similar software, CROs can detect patterns and visualize the information. This will eliminate the need for excess trials and aid pharmaceutical companies and researchers in creating a better product.

Advanced analytics could help get medications to the healthcare market faster, Venture Beat claimed. Mobile apps such as Apple's ResearchKit can help CROs speed up patient recruitment, which leads to an earlier start date to the study. Wearables may also reduce the number of times people need to physically appear at clinic meetings, as they can send data from their devices or researchers can monitor them remotely.

"As mHealth technologies become more sophisticated and intuitive, there is tremendous opportunity to use them in clinical trials," Kara Dennis, managing director of mHealth at Medidata, told PharmaVOICE. "These technologies have the potential to help gather more and better data on patients' response to therapy and progression of disease. Still, as with any transformative technology, mHealth tools present the industry with new operational, technical, and regulatory challenges."

Wearable devices provide myriad health information to CROs to help with medication development.Wearable devices provide myriad health information to CROs to help with medication development.

Problems need to be fixed before implementation
As with all new technology and processes, further research is needed to fully understand how wearables can be used in healthcare. To get the complete experience, those in the medical industry will have to determine the best design and usage for them through trial and error.

In the fitness world, users generally abandon their devices within six months because they are uncomfortable or need to be taken off too frequently, according to InformationWeek. While clinical trials have a time limit, their wearable devices will need to have a design that will ensure participants keep them on for the duration of the study.

Researchers will also need to determine an action plan that accounts for the non-controlled settings in which patients would be wearing the devices. There are also various types on the market, which create an inconsistency in the data collected. Because people behave differently in their daily lives and use myriad wearables, the information wouldn't be the same across the board, PharmaVOICE explained. Standards would need to be created to help with the use and monitoring of the devices. Researchers would need to determine how to balance the quantity and quality of data received.

"Planning for variability will require pre-determining the context within which data will be evaluated to determine what variability is acceptable, and what will be required in trial design to drive to the right degrees of statistical power and significance," Thaddeus Wolfram, senior manager of life sciences advisory practice at EY, told the source.

Despite the early stages of the devices, wearables could make a significant difference in the way clinical trials are conducted.

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