By Ryan Beckland

Throughout the duration of a study, researchers must frequently monitor clinical trial participants’ reactions to a drug and capture precise sets of measurements. These measurements have traditionally been gathered at frequent office visits or through constant at-home manual tracking by the participants. Utilizing digital health devices in remote patient monitoring can streamline the process, however, and enable the seamless collection of key biometric and activity data. Those patient insights can then be quickly transmitted directly to clinicians. This approach reduces the need for costly and time-consuming in-person evaluations and enables shorter clinical trial duration, benefitting researchers and trial participants alike.

Greater visibility for researchers

By arming participants with wearable and FDA Class II medical devices, sensors and mobile applications, researchers gain greater visibility, providing the following benefits:

• Holistic and objective view of a participant’s response to a drug. Researchers can gain a more holistic picture of a participant’s response to a drug by continuously collecting data from digital health devices between office visits. Additionally, the data collected via digital health devices is more objective than relying on a participant’s subjective recall, which can be skewed based on how he or she is feeling that day. 
• Earlier decision-making. Access to real-time data provides researchers the ability to make amendments to protocols and go or no-go decisions based on how participants are reacting to a drug. Early signals can also be detected to help identify whether the drug is more effective for specific subsets of the study population, as well as understand the impact of participant behaviors.
• More accurate intervention triggers. Data from digital health devices can alert researchers to potential adverse events sooner. Conversely, a lack of data transmitted from the devices is also informative—such as alerting researchers to potential non-adherence, thus providing them with better operational insight. For example, a null report from a connected glucose meter can trigger a reminder for the participant to take a reading or communication from the investigator to assess for other issues.

Patient-centric protocols enhance participant enrollment and engagement

Remote patient monitoring also enables pharmaceutical companies to design trial protocols that are patient-centric, reducing the burden on participants and enhancing engagement in a number of ways:

• Fewer office visits. Cumbersome trial requirements can deter patients from enrolling in a trial. By collecting data remotely, sponsors can design trials with fewer office visits, which can increase the likelihood that patients will or can enroll in a trial.
• Reduced recall burden. Trial sponsors are frequently concerned about the validity of patient recall. With remote monitoring, the continuous and real-time stream of data can provide feedback in a more consistent and comprehensive manner—thus reducing the burden on patients to recall information in a detailed manner.
• Less manual entry. Since data is automatically integrated from digital health devices, participants don’t need to track or record it manually. This reduces the potential for errors, as well as the time and effort required to record it.

As the pharmaceutical industry continues to embrace digital health offerings and the impact they can have on the drug development process, we’ll see all involved stakeholders benefit, and ultimately, the more efficient creation of drugs that can significantly impact patient lives.