Remote participant monitoring (RPM) approaches provide sponsors, investigators, and healthcare professionals a real-time and more comprehensive look into participants’ health—but these approaches must also work for the people they serve. Learn how participant input can help improve these technologies and ensure data quality and integrity while maintaining participants’ safety and care.
Remote participant monitoring (RPM) uses participant-centric technologies to improve health outcomes in the standard healthcare and pharmaceutical systems, including telemedicine. The same technologies and telehealth may also be used in modern clinical trials such as decentralized clinical trials (DCTs) to optimize efficiencies while obtaining quality data and serving participants with convenient access to care.
RPM offers many benefits for medical product developers, healthcare professionals, and participants alike. However, there are still some challenges that—if not properly addressed during trial design—can reduce trial and technology accessibility.
Issues to consider when thinking about incorporating RPM into a trial design:
- Power sources: Many RPM solutions run on batteries continuously to collect and send data from participants to investigators and medical professionals. This equipment must function according to its battery life to ensure the energy power doesn’t run out too fast or during critical moments of data collection. Additionally, not all participants around the world have access to electricity as a power source, which restricts use of these types of RPM technologies.
- Safety: RPM tools undergo rigorous verification, validation, and quality assurance (QA) and quality control (QC) testing, but the need for adopting fit-for-purpose technologies in a trial may require key considerations for usability. For instance, input voltage range, feedback mechanisms, output regulation, and output power and size considerations must all be considered when designing portable participant digital medical devices. Continued testing and monitoring of these medical devices under a QA/QC program ensures correct functioning within the specific context of use, reduces risks linked to malfunction, and helps eliminate safety concerns.
- Security: Participants need to know that their data is safe when transferred across digital medical devices and electronic platforms using RPM. RPM technologies like sensor patches may deliver participant data to healthcare providers in real-time, but that information and other outputs derived from diverse digital sources may be targeted by data thefts. Best-in-class security measures are critical to protecting participant data against attacks both during and after data transmission.
- Convenience: RPM may integrate with devices that participants already use. Ensuring devices are compatible with iOS, Android, Bluetooth, and other frequently used mobile interfaces will make RPM devices more convenient and effective for participants and investigators in many different settings.
Reducing the Burden of Participation for Participants and Healthcare Professionals
Remote participant monitoring allows health professionals to connect with participants in ways not previously possible. Surveys show that during the COVID-19 pandemic, telehealth visits increased by up to 86% during the first two weeks of the stay-at-home order in the United States. RPM helps decrease in-person visits, saving time and creating more cost-effective ways for participants to get the care they need. Additionally, RPM reduces or eliminates the amount of travel and associated costs often required for clinical trial participation, making care more accessible. Doctors, investigators, and other medical professionals can connect with participants from a distance—often using devices participants are already familiar with—leading to fewer visits to trial sites, higher participation, and increased participant retention rates.
These technologies can also help sponsors reach participants in minority and vulnerable groups that are often excluded from clinical research, including Black people, Indigenous populations, and people of color (BIPOC), LGBTQ+, low-income, and disabled people. Ensuring a more diverse participant population helps investigators obtain more robust, quality data and, ultimately, understand more accurately the safety and efficacy of a novel medical product in all people, not just a small sector of the population in multiple societies globally. RPM technology has improved throughout the pandemic due to a variety of safety measures, including social distancing. These improvements are helping medical product developers collect quality data and open clinical trials up to more people around the world.
Bringing Better Care to Participants Globally
Once sponsors understand how RPM does and doesn’t work for participants, they can continue to implement tools that make clinical trials work more efficiently for all involved—especially participants. Innovators may consider existing challenges with RPM, as well as how current technology benefits participants. Listening to what participants do and don’t appreciate about the technology and incorporating their feedback into creating more accessible technology is essential. This is called usability assessment and feasibility.
RPM can also yield new insights about participants when they are able to personalize their care and communicate with medical professionals more easily. RPM helps participants manage symptoms and get more immediate care in ways not previously possible without in-person doctor visits and expenses. It gathers more accurate and consistent data for investigators to analyze and use to improve care and treatments for more people.
RPM provides sponsors, investigators, and healthcare professionals a real-time look into participants’ health—but these tools must also work for the participants they serve. As the clinical research industry continues to improve upon these technologies, it’s important to remember how they impact participants so that we can provide them with the best possible care.
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