Remote monitoring is a method of supervising clinical trials from a distance, negating the need for researchers to interact with volunteers at a specific site.
This type of clinical trial monitoring has become more popular over recent years – particularly due to the challenges presented by the COVID-19 pandemic – and has proven to have many unique advantages.
We’ve explored remote monitoring in clinical trials to determine how it works, the challenges it presents, the benefits it can offer, and the impact it will have on medical research in the future.
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Types of monitoring in clinical trials
The types of monitoring usually undertaken in clinical trials include:
- On-site monitoring – visiting the trial site to review processes, verify data, and ensure compliance
- Remote monitoring – using digital tools to oversee activities and review data from a separate location to the participants
- Centralized monitoring – analyzing data collected from multiple sites to identify trends, anomalies, or risks
- Risk-based monitoring – allocating monitoring resources based on the risks associated with the study
What does remote monitoring in clinical trials mean?
Remote clinical trial monitoring involves overseeing research activities, collecting data, and reviewing and analyzing the results without any face-to face interaction with participants.
Instead of attending a trial site, volunteers are monitored and assessed from a separate location, and researchers use technology to gather information and observations. This means remote monitoring can potentially take place anywhere in the world, provided the technology supports it.
Benefits of remote monitoring
This type of clinical trial monitoring has several benefits, including better recruitment, enhanced patient safety, and improved trial efficiency.
Increased patient recruitment and retention
By accessing the trials remotely, there’s no need for volunteers to attend a trial site. This means participants can join from a much wider geographical area, and more people are willing to take part due to the simplified recruiting process. In addition, drop-out rates are usually much lower as it eliminates the need for frequent site visits, increasing convenience and making it easier for the participants to stay in the study.
Enhanced data quality and real-time access
These studies use advanced technology, which can result in more reliable outcomes. The information gathered by the sophisticated digital tools is highly accurate, and the data can be accessed in real-time, enabling on-the-spot analysis for more dynamic and responsive trial management.
Cost efficiency and resource allocation
Patient travel expenses are usually paid by the research company, and these can be avoided entirely. Remote monitoring also cuts the costs associated with on-site observation, such as additional personnel, energy supplies, and room rental. As a result, more resources can be allocated to critical areas such as data analysis, technology, and patient support, improving the efficiency and effectiveness of the research.
Improved patient safety and outcomes
Participants' health data can be traced continuously, ensuring a more detailed analysis of their condition, and a tailored treatment approach where appropriate. In addition, this live data immediately flags any adverse events, so any necessary interventions can be put in place straight away.
What types of clinical trials use remote monitoring?
Several types of clinical research use remote monitoring, including:
- interventional studies – tests for new medical interventions that assess patient outcomes and and side effects in real time
- observational studies – research that observes outcomes without any interventions, and collects data about patients’ health and/or behavior
- decentralized trials – completed through digital health technologies and telemedicine, enabling participants to join from any location
- post-marketing surveillance – assessing the long-term effectiveness and safety of new treatments in the general population
Tools used for remote monitoring in clinical trials
Most remotely monitored trials use a variety of tools to ensure consistent and accurate data collection and analysis. They might use:
- digital data collection tools (eg. mobile apps and wearables) to gather and share information
- data management systems to save, process, and analyze data
- patient engagement platforms (including telemedicine and patient portals) to allow participants and researchers to communicate
- regulatory compliance frameworks that ensure the monitoring adheres to ethical and legal requirements
How remote monitoring in clinical trials works
Several important stages are involved in planning, implementing, and gathering the results of remote monitoring.
Preparation and planning
A comprehensive plan is created, detailing the remote monitoring strategy along with timelines, data review schedules, and communication protocols.
The appropriate digital platforms and devices are then selected to ensure the data is collected and analyzed accurately, and communication is easy and secure for everyone involved.
This is supported by a comprehensive programme of training for both site staff and remote monitors, giving everyone a detailed understanding of the technology and trial protocols.
Patient enrollment and consent
The enrollment process is managed digitally, so patients can easily join the trial, regardless of where they’re located. This involves a digital consent process, which requires volunteers to read, understand, and agree to the trial protocols.
Monitoring and oversight
The research team will regularly review the data to assess the effectiveness of the intervention and the safety of the patients. They will also make sure the trial is adhering with the study protocol, ethical guidelines, and regulatory requirements.
Quality control and compliance
The research team will ensure the integrity of the data by frequently checking it for accuracy and reliability. They will also complete regulatory compliance reviews to be confident that the trial is adhering with applicable regulations, laws, and guidelines.
Issue resolution and support
Staff will promptly identify and resolve any issues that arise to minimize the impact on the trial – which can include anything from technical glitches to protocol deviations. Trial participants will also receive ongoing support from the researchers who will quickly respond to any queries that are raised.
Data collection and transmission
Digital devices, such as mobile apps, wearables, and other digital tools, continuously gather participant health data in real time. They use encryption and other security measures to ensure data is transmitted securely, protecting patient privacy.
Reporting and analysis
Statistical methods and data visualization tools are used to analyze the data and reach conclusions about the safety and effectiveness of the medical intervention being tested. A detailed report is then prepared for the sponsors, regulatory bodies, and the wider scientific community.
Closure and follow-up
Once the trial activities are complete and the data is collected, the study can formally close.
After the trial, it might be necessary to collect additional data from the participants to assess long-term outcomes, ensuring the scientists have a thorough understanding of the intervention’s impacts.
Challenges and considerations of remote monitoring
Remote monitoring can present unique difficulties for trial organizers. Because the information is gathered online, data security and reliability are extremely important. As such, the technology should use end-to-end encryption to prevent breaches, and it should be reliable and robust, with any malfunctions corrected swiftly.
If the participants are inputting manual data, extensive training and reminders will also be required to prevent mistakes and ensure accuracy, However, this can often be avoided by using tracking devices that automatically gather the information.
In addition, maintaining participants’ involvement and compliance from a distance can be a challenge, so it’s important that the study is easy and straightforward for all participants.
Researchers must also remain up-to-date with evolving regulations and guidelines related to remote monitoring, which will require some time and dedication.
Future directions and trends
Researchers recognize the unique benefits of remote clinical trials, and as such, we can expect more hybrid or fully decentralized trials to take place going forward. In support of this shift, protocols and monitoring tools will be developed to attract more participants, enhancing convenience and minimizing the burden of the research.
Researchers will also strive to standardize global remote monitoring and digital health technology regulations to facilitate international studies.
In addition, artificial intelligence will undoubtedly play a larger role in assessing the vast amounts of information that can be collected remotely – completing analysis and identifying trends far faster than we’re able to currently.
Conclusion
Although remote monitoring presents its challenges, it has the capability to significantly advance clinical trial management.
The flexible and efficient nature of the method allows researchers to access many more participants, gather improved, real-time data, save significant costs, and address some of the challenges traditional methods present.
As such, we can expect remote monitoring to become a more integral and commonly used research method, helping to accelerate medical discoveries and improve patient care and outcomes.
FAQs
Can all types of clinical trials be conducted remotely?
Many trials can incorporate remote monitoring. However, whether it can be used for an individual study depends on its unique requirements, the intervention being tested, and whether any in-person procedures are needed.
How do regulatory bodies view remote monitoring in clinical trials?
Regulatory bodies recognize the practicality and value of remote monitoring, which were highlighted during the COVID-19 pandemic. They are currently reviewing and updating the related regulations and guidelines to ensure patient safety and trial integrity.
What steps are taken to ensure the privacy and security of data in remote monitoring?
These types of trials use encrypted data transmission and secure data storage solutions to ensure patient information is protected. They must also comply with any privacy laws within the region, such as GDPR or HIPAA.