Over the past few years, remote patient monitoring (RPM) has gained traction as an effective way to improve clinical outcomes in healthcare. It's now being used in decentralized clinical trials (DCTs), a new kind of trial that is quickly becoming the norm.
Definition of clinical trial monitoring – an introduction
The term “clinical trial monitoring” is used to describe the process of tracking and reviewing the progress of a clinical trial. The goal of clinical trial monitoring is to ensure that the trial is conducted according to the protocol, that the patient data is accurately tracked and recorded, and that the patient's safety is maintained.
Remote patient monitoring in clinical trials explained further
In recent years, the use of remote patient monitoring (RPM) has become increasingly popular in clinical trial spaces. RPM allows for the collection and transmission of data from patients to clinical staff without the need for in-person visits. This can be beneficial for both patients and sponsors, as it makes trial participation more convenient, improves data quality and reduces costs.
Challenges of traditional monitoring in comparison to RPM in clinical trials
There are a number of challenges that come with traditional monitoring in clinical trials in comparison to RPM:
One of the biggest challenges is that traditional methods require onsite visits from monitors, which can be logistically difficult and expensive. Additionally, these onsite visits can often disrupt the flow of the trial, as monitors may need to see multiple sites in a single day.
2. Accurate and timely data
Another challenge with traditional monitoring is that it is difficult to get accurate and timely data. This is due to the fact that traditional methods often rely on paper-based documentation, which can be easily lost or misplaced. Additionally, data may not be captured in real-time, making it more difficult to identify issues early on.
RPM, on the other hand, offers a number of advantages that help to overcome these challenges…
Main benefits of RPM in decentralized patient trials
There are many benefits of using RPM in decentralized clinical trials:
1. Patient compliance
One of the main benefits of RPM is that it helps improve patient compliance. This is because patients can be monitored more closely, and they are more likely to stick to their treatment plan if they know that they are being monitored.
2. Reduced costs
RPM can help to reduce costs associated with clinical trials by reducing the need for travel and on-site visits.
3. Faster enrollment in trials
RPM can help speed up the enrollment process by allowing patients to enroll from their homes rather than having to travel to a central location.
4. Improved data quality
RPM can help to improve data quality by providing real-time data that is more accurate than data collected via paper-based methods.
How to deploy RPM in decentralized clinical trials
There is no one-size-fits-all answer to the question of how to deploy RPM in decentralized clinical trials. The approach that is best for a particular trial will depend on a number of factors, including the type of disease being studied, the size and geographic distribution of the patient population, and the resources that are available.
There are some general principles that should be followed when planning and implementing an RPM strategy for a decentralized clinical trial. Below are the six key considerations for successfully deploying RPM in a decentralized setting.
Define the scope of the RPM program.
Before anything else, it is important to define the goals and objectives of the RPM program. What data do you want to collect? How will it be used? Who will have access to it? Answering these questions will help to determine what type of RPM system is best suited for your needs.
Select the right technology platform.
There are a number of different technology platforms available for collecting and storing patient data. It is important to select one that is scalable, secure, and compliant with regulations such as HIPAA.
Train study staff on using the RPM system.
All staff who will be involved in using the RPM system need to be properly trained on how to use it. This includes both those who will be responsible for setting up the system and those who will be interacting with patients on a daily basis. Training should cover all
A word about wearable sensors for RPM in Patient clinical trials
Using wearable sensors in clinical trials has been shown to be a valuable addition both for patients and the trial conductors. Due to their ability to provide real-time data on subjects' physiological responses, researchers can implement wearable sensors to track the health of people during clinical trials, track vital health metrics, understand how people feel and respond to treatments and ascertain more effective treatment options.
With wearable sensors, clinicians can improve patient care and the safety of clinical trials. Such devices can be used to measure heart rate, blood pressure, carbon dioxide levels, and other vital signs.
The device is usually worn on a person’s body, as they go about their day. It captures data about a person’s physiology, including heart rate, breathing rate, and perspiration levels. Through a wireless connection, the researcher receives the information gathered by the device and analyzes it. In addition, the information is stored in a database so that researchers can observe changes over time.
The benefits of wearable sensors in clinical trials are numerous and include the following:
Remote trials tend to be more patient-centric - Making decentralized clinical studies more convenient for patients, especially those with chronic diseases such as congestive heart failure, diabetes, and hypertension.
Remote trials give more accurate readings - As patients are monitored in their natural environment rather than a clinical setting where factors such as white coat hypertension can affect readings. For example, measuring blood pressure at home can solve the challenge of white coat hypertension.
Wearable sensors can help identify unexpected data findings - Remote patient monitoring (RPM) allows for a significant amount of data to be collected, including early detection of clinically significant hypertension during dialysis. RPMs come with an early warning score that triggers an alert if something goes wrong during dialysis, which can be challenging to detect with traditional measurement methods that are usually collected before or after dialysis.
Individualized drug prescribing - Similar alerts can also be applied for an array of physiological parameters in pharmaceutical clinical trials. For example, with RPM, it is even possible that physiological monitoring can lead to custom instructions for patients taking a particular drug. Some patients with high blood pressure may benefit more if they take a hypertension drug at night, while others will benefit more by taking it in the morning. RPM can monitor a patient’s vitals and let the researcher know which is better.
Warning alerts before a medical event - Researchers can use wearable sensors to determine if a patient is at risk of having a heart attack or stroke by monitoring their heart rate, blood pressure, and other vital signs. With these devices, doctors can monitor patients' health closely, allowing them to detect any changes that might signal an emergency. Doctors can decide when to administer treatment, improving a patient’s chances of survival.
Helping patients play an active role in responsibility for their health - Wearable sensors also give valuable insight into human behavior: they ‘force’ participants to take an active role in their own health, while the collected data can assist them in making better health and well-being decisions.
Attracting and encouraging more people to participate - As the RPM experience is less invasive than other clinical trial options, such as blood tests and physical examples, more people may be willing to participate, leading to a wider and more accurate data pool for researchers to dip into to gain knowledge and insights. Furthermore, wearable sensors can be utilized for both longitudinal and cross-sectional studies, enabling the collection of data over a period of time and even in real-time during a study.
Biobeat – The most advanced system for Remote Patient Monitoring
Biobeat is at the forefront of the Remote Patient Monitoring space with its cutting-edge platform, which represents the next generation of Health AI. Using wireless, non-invasive medical-grade technology and machine learning algorithms, our remote patient monitoring platform measures vital signs in real-time, enabling the provision of actionable insights on patient care.
The platform provides everything that pharma companies require for effectively and efficiently monitoring patients participating in a clinical trial:
Provides an Early Warning Score with customized thresholds per patient and scenario. Identifies changes in vitals and alert on high-risk patients Enables access to real-time patient data paired with AI capabilities to provide insights on trends and bring efficiency into the process of healthcare delivery Optimizes all data collection, providing medical staff the required clinical data instantly Empowers healthcare practitioners to adopt a data-driven approach to personalized medicine
Short and long-term remote monitoring solutions for clinical trials
Biobeat provides two key solutions for both short and long-term patient monitoring in clinical trials as follows:
For short-term monitoring, the company has developed a uniquely disposable, non-invasive, comfortable chest monitor.
For long-term monitoring, Biobeat provides a state-of-the-art wrist monitor similar in appearance to a wrist watch. The idea is that the patient being monitored in the trial can put the device on, like any other watch, and go about their day in their natural environment. The monitor is comfortable and non-invasive, causing no disruption to patient lifestyle or quality of life. Vitals are measured and transmitted to the cloud for the most accurate, real-time monitoring.
Biobeats unique benefits for pharma companies conducting clinical trials
Biobeat offers a unique solution for pharmaceutical companies conducting clinical trials as it allows for the measurement of a diverse range of health parameters using just one device. The system collects millions of data points per patient per day, made possible through proprietary data collection tools available through either a wrist-monitor or chest-monitor. Biobeat's PPG sensor is used in both devices, which is developed in-house and patented globally. This innovative technology provides an efficient and convenient method for monitoring patients in clinical trials, allowing for more comprehensive data collection and analysis.
Each of these devices is able to automatically measure thirteen vital signs, continuously, wirelessly and in real time:
With the help of those capabilities mentioned, should accelerate the organization time-to-market strategy, improving the drug development process and the regulatory framework for each new discovery.
Moreover, Biobeat’s AI and ML tools enable for sub-categorize data point for more granular and personalized data effecting the medication dosage and effectiveness.
Conclusion: RPM enables and supports decentralized clinical trial patient monitoring
Clinical trials should leverage RPM and wearable sensors to gather data and improve patient care. Using RPM in decentralized clinical trials improves patient engagement and retention, increases efficiency, and reduces costs. RPM has the potential to improve data quality by providing more accurate and timely information about a patient’s condition on a larger-scale, due to its ability to encourage more people to take part in the trial, and by removing any existing geographical barriers.