Consumer health monitoring apps and devices have become popular tools to help individuals monitor and track their personal information. However, they are not the most viable data collection option for medical research. Pharmaceutical and clinical researchers looking for alternative ways to obtain data during the COVID-19 pandemic saw wearable devices, such as the Apple Watch and Fitbit, or user-reported data, as potential sources. given widespread availability and convenience, but the inconsistency has proven to be prohibitive.
Obtaining quality data while adhering to pandemic protocols has resulted in increased use of medical grade remote patient monitoring (RPM) technologies. As the use of RPM technology in clinical studies occurred before the pandemic, industry has been forced to pay more attention to its value, especially given the realities of inconsistencies, or black holes, in personal device data.
Vivalink, a leading provider of connected health solutions, asked pharmacy, biotechnology and clinical research professionals about their views on the current state of RPM and how technology has advanced healthcare professionals. decentralized clinical trials (DCT).
At the end of 2019, there was almost 326,000 clinical trials registered In progress. However, when much of the world closed in 2020 due to COVID-19, participants were reluctant to visit clinical facilities even with social distancing guidelines, and clinical sites were reluctant to agree to host tests. Savvy researchers have had to find ways to adapt to avoid serious disruption to the drug development process so dependent on successful product trials. Finding ways to encourage safe participation and expand the site’s reach included openness to decentralized trials.
The investigation reveals that nearly half (44%) have already adopted RPM for decentralized clinical trials or plan to do so within the next 12 months. The adoption of remote monitoring during testing largely stems from COVID-19, as 65% of those surveyed reported concerns about the pandemic as their primary driver for using RPM technology.
Data from RPM devices can be very useful, but only if the integrity of the data is consistent and never changes. There have been issues with research studies attempting to use data from portable consumer devices, like Apple Watches, which alter internal algorithms to process raw data, resulting in different results without the researcher’s knowledge. For example, the heart rate derived from portable consumer devices is based on the raw signals from the device which are filtered and interpreted using an internal “black box” algorithm. But if the algorithm changes, the results may vary. An alternative is to provide the raw data to the researcher so that they can control how they are processed.
While consumer healthcare devices are convenient, the issue for researchers is data integrity according to the requirements of the trial. Successful testing requires repeatable and consistent science, which is difficult with devices and applications filtered by unknown software. Data summaries through Apple and Google software are not always clinically validated and algorithms may change without notice. For example, JP Onnela, Associate Professor of Biostatistics at Harvard TH Chan School of Public Health, cited differences in data from portable devices by noting changes in algorithms that filter and analyze the information. Medical grade wearable devices such as those from Vivalink run on an enhanced platform to deliver raw and processed data so that researchers can extract the right types of data based on their research.
Over 70% of survey respondents said they used video conferencing and telemedicine for DCT participants to capture rudimentary data through observation and self-report. While this is a simple method that works, it only provides a limited window into what is happening with the patient over time. In the survey, 94 percent of those surveyed responded that continuous data entry, defined as 24 hours or more, was important to their trials. While most physiological parameters are important to monitor across the board, heart rate and blood pressure were cited as the most important to monitor for trials, with 69% and 57% citing them respectively. RPM portable devices can deliver a richer data set that improves the security and efficiency of the entire development process.
Continuous, automated data collection results in more contextual data. The time and date, even environmental factors such as pollen counts for those participating in lung or respiratory trials, provide a more viable dataset beyond physiological parameters alone. It is important to note a change in temperature, but this information is more valuable if it correlates with other simultaneous information such as an increase in heart rate or respiratory rate.
In pharmaceutical test which required temperature data to help monitor a potential side effect of a neurological drug, Vivalink auxiliary temperature monitors provided up to 50 readings per day for 21 days through a decentralized process. In this case, the data collection was performed automatically while the patient was outpatient and remotely. The ability to conduct a study without requiring participants to visit the sites opens up the possibility of wider geographic recruitment that could significantly speed up a trial.
While the use of RPM is certainly gaining popularity in clinical trials, patient adherence is the biggest challenge, with 69% of respondents noting. An advantage of portable medical devices is not only that they can capture multiple data points using a small form factor, but they can also be designed as a portable consumer device with ease of use at home. ‘spirit, which contributes significantly to the grip.
Without a doubt, COVID-19 has accelerated the demand for remote monitoring of patients, as evidenced by the rapid adoption over the past year and the continued adaptation of clinical trials to a decentralized model.
As the clinical environment moves to the patient’s home, it is important to design products that can be easily used by average consumers, while obtaining medical-grade data. This is the key to accelerate the adoption of RPM technologies for DCT.
Jiang Li, Founder and CEO, has both passion and extensive experience in bringing innovative technologies and products to market. Li’s nearly 20-year high-tech career took a new direction when a routine health check took him to the emergency room for examination, fearing he might be in the hospital. in the middle of a heart attack. Noticing outdated surveillance technologies in the hospital, he knew that emerging technologies could be properly implemented and sought to apply his experience in flexible electronics to healthcare. Prior to joining Vivalink, he was responsible for the development of new products and technologies as vice president of engineering at Kovio and Thinfilm Electronics, the leading printed electronics companies. Prior to that, he worked at AMD and in the AMD / Fujitsu joint venture, Spansion. As Vice President of Product Engineering at Spansion, Jiang managed major new product launches in Spansion. Jiang holds a doctorate. degree from the University of Wisconsin-Madison and a bachelor’s degree from Zhejiang University in China.