Since the COVID-19 pandemic, remote monitoring in clinical trials has become increasingly popular. During the pandemic, on-site trial participation became disrupted, making it very difficult, if not impossible, to conduct on-site clinical monitoring. This forced the clinical research industry to explore the possibilities of remote monitoring.
Remote monitoring allows the investigator to collect and review data without visiting a site or patient in-person. Instead, the data is received digitally.
Even as much of the industry has returned to ‘normal’ after COVID-19, remote monitoring in clinical trials still remains a popular and effective option, offering CRO’s many benefits that assist in the clinical trial process. In this guide, we’ll explore the many benefits, alongside the challenges to consider.
What is Remote Monitoring in Clinical Trials?
Clinical monitoring is a key part of clinical trial site management, and is the way researchers keep a close eye on how the trial is going. This is done to make sure that the participants are safe, understand how patients are responding to treatments, and the trial is being conducted in adherence to standard protocols and procedures.
It is extremely important to ensure that clinical trials have effective clinical monitoring, because they involve human subjects. Having the correct monitoring place helps to safeguard study participants, and flag any adverse effects so that they can be reacted to swiftly.
For any clinical trial that involves testing new treatments, it’s necessary to have specific plans in place to monitor everything from the regulatory compliance of the trial, to the well-being and health of the participants. These plans cover all three main phases of the research.
During a clinical trial, clinical monitoring oversees several important aspects:
- Making sure the trial is compliant with the clinical study protocol.
- Keeping detailed records and managing the data collected during the trial.
- Reporting any adverse events that happen during the trial.
- Ensuring that the participants understand the trial and complete consent forms.
- Compliance with the necessary rules and regulations.
How Does Remote Monitoring Work?
Remote monitoring is part of a decentralised clinical trial workflow, and is a way of keeping an eye on clinical trial research, and any data that is generated from the study, without being on site. Instead of being physically present at the location where the research is happening, monitoring is done remotely, utilising technology which allows for easy digital data transfer, collection, and review.
Remote monitoring in a clinical trial can help improve communication between the research site and the sponsor. Technology systems allow monitoring personnel and sponsors to share notifications, messages, and other important information all in one convenient platform.
Participants of the clinical trial are given instructions to follow, which may include performing certain tasks for the study, and filling out dairies or other forms of regular records. This can be combined with having video calls with the clinical trial team, so discuss further steps, ask questions, or voice any concerns they might have.
The digital nature of remote monitoring in clinical trials means any participant feedback can be reviewed almost immediately, granting the monitors and clinical team much more time to respond to any challenges or concerns.
The Benefits of Remote Monitoring For Clinical Trials
Remote monitoring in clinical trials offers a slew of benefits that allow monitors and CROs to make the clinical trial process more efficient and effective. These benefits include:
- Improved trial efficiency
- Enhanced data quality
- Increased patient safety
- Lower costs
Improved Clinical Trial Efficiency
One of the major benefits that remote monitoring in clinical trials offers is that it can make the monitoring process much more efficient, which helps with the overall success of the clinical trial.
For a clinical monitor to collect results in-person, it means either the participant has to travel to a site, or the monitor needs to travel to the participant’s home. In both cases, it takes more time to collect data as schedules need to match up, as well as the physical amount of time it takes to travel.
Digitally collecting and monitoring data is much more efficient, whether it’s through participant written logs, or via a virtual ‘face-to-face’ meeting. Because this process is so much more efficient, it means reviewing the data can happen earlier too – depending on the remote monitoring methods used, reviewing data can start as early as day 1.
Respond Faster
Remote monitoring also allows the clinical team to respond to queries, challenges and outliers in the data. Because data can be submitted without having to wait for an in-person visit, data is typically processed faster.
Part of this fast response could be contacting participants who have stopped submitting data. If caught early, this could help CROs address potential site burden that is causing participants to stop submitting data and drop out of the trial. The higher the participant engagement and retention rates, the higher quality the overall data is likely to be.
Enhanced Data Quality
Due to the nature of remote monitoring, with instructions, participants can log their experiences digitally. Because of how easy this process can be, daily or even hourly logs can be very achievable, without taking too much time from the participant’s schedule. This means more data can be collected, resulting in a potentially much larger sample size, which typically means more accurate data.
Increased Patient Safety
Using remote monitoring in a clinical trial can help to increase the safety of participants in multiple ways, by reducing face-to-face contact, and by being able to respond faster to adverse data submitted by participants.
Due to the nature of remote monitoring, there is significantly less face-to-face interaction, which can help protect more vulnerable participants from potential exposure to harmful contaminants or diseases.
With more immediate access to data, remote monitoring can help identify adverse events much faster. In a remote setup, participant should have constant access to a member of the clinical team via messaging or alerts, should they need it.
In contrast, the traditional site-based approach has limitations in communication, making it easier for adverse events or serious adverse events to go unnoticed or unreported for longer. As a result, clinical trials with remote monitoring can be safer for patients, as potential issues can be addressed promptly and effectively.
Lower Costs
Remote monitoring can help to lower the costs involved for a clinical trial because it doesn’t require face-to-face interactions, which reduces the costs in both travel and the need for a physical site for participants to go to.
Another way remote monitoring can help to bring down the costs is by streamlining the data collection and management process. Data can be acquired faster, and with fewer obstacles. Lacking sufficient data can delay clinical trials, which can be very costly – one day of delays in a clinical trial can cost anywhere between £450,000 to £6,000,000.
An additional benefit to the remote monitoring is that participants can participate from home. In this setting, participants are more likely to be more comfortable and secure. Not only does this reduce the costs associated with trial site management, home-based studies can also lead to improved patient retention, therefore saving costs.
The Challenges of Using Remote Monitoring in Clinical Trials
While the use of remote monitoring in clinical trial environments certainly offers a range of benefits, it also has its own set of challenges that need to be accounted for. Considering these challenges is key in maintaining the integrity of the clinical trials, ensuring participant safety, and making sure data is managed correctly.
Technology Adoption
One of the most obvious challenges that the effective use of remote monitoring faces is adopting new technologies, by participants, clinical teams, and the clinical trial industry as a whole.
Participants
While for some participants, particularly those who are digitally proficient, remote monitoring may offer a more convenient and easier solution. This is because they are more likely to be able to learn new software or technology with only a small amount of guidance.
However, there will be many people who will struggle to adapt to it easily, potentially increasing their site burden, even though they’re at home. To combat this, researchers should provide clear and easy to understand instructions, helping participants submit data and follow procedures with ease.
Clinical Teams
The clinical team needs to adapt to new technologies first, before it can be rolled out to any trial participants. It’s crucial that clinical teams are fully knowledgeable in the trial’s remote monitoring software. Without this knowledge, they are unable to educate participants on how to use it.
Clinical personnel must also be well-versed in remote monitoring software for the sake of data quality. As a process that revolves around collecting and managing patient data, it’s key that remote monitoring data is handled in the correct way. For instance, clinical teams must be aware of how data should be stored and processed.
Data Privacy & Protection
Another consideration in remote monitoring is data privacy and protection. Clinical research deals with Protected Health Information (PHI), which is one of the most sensitive types of personal data.
It’s crucial that remote monitoring activities prioritise the protection of PHI, ensuring that patient data is not compromised.
One way that remote monitoring teams can do this is with study ID numbers for patient names. This links the patient with an allocated ID, which is kept securely and only accessible to the research team. Additionally, monitoring databases should be password protected with access systems.
Regulatory Considerations
With remote monitoring solutions, comes the issue of making sure that the whole clinical trial process still complies with regulatory considerations. Because there are many different solutions and methods available when it comes to remote monitoring, it can be difficult to find a method that meets regulatory requirements, allows monitors to access the data they need quickly, and makes it easy for participants to submit data.
The main requirements needed in a solution or workflow are:
- Meets data protection requirements.
- Meets clinical regulation requirements.
- It is easy for monitors to access data quickly, and from any location.
- It is easy for participants to submit data.
- Participants must have access to clinical team staff when needed.
Some of the main considerations that need to be addressed so that remote monitoring meets regulatory guidelines are:
Researcher Regulation Familiarity
Researchers must be familiar with the relevant regulatory guidance for remote monitoring in their specific region or country. Providing the necessary training and resources to inform researchers should be a key task of any CRO.
Informed Consent
Participants must provide informed consent for remote monitoring, and they should be fully informed of the procedures, potential risks, and benefits associated with the remote monitoring process. Ideally resources should be produced and on-hand, either physically or digitally, so that participants can easily access this information whenever they need or want to.
Regulatory Reporting
Researchers and sponsors must comply with any reporting requirements set forth by regulatory authorities. This includes the submission of study data and safety reports.
Training and Standard Operating Procedure
Study personnel involved in remote monitoring should be appropriately trained, and Standard Operating Procedures should be in place to guide the remote monitoring process. This is important as remote monitoring inherently contains more, separate moving parts, which need to be standardised as much as possible.
The Latest Technology in Remote Monitoring
The effectiveness of remote monitoring can be influenced by the chosen approach. It is crucial to ensure that data and documents remain under the ownership of the site to comply with GCP standards. Additionally, granting sites control over monitor access is essential.
There are three common options available for remote monitoring of clinical trials:
Sponsor-driven remote monitoring: Initially, this was the most prevalent method, requiring software solutions that integrate with existing site technologies and workflows. This presented technology compatibility issues with existing software or needed bespoke software that would work with current workflows, which could be costly.
Site-managed electronic investigator site file (eISF) platforms: Recently, these platforms have gained popularity. They are connected to the sponsor’s electronic trial master file (eTMF) and align with both site processes and sponsor requirements. They enable proactive workflow improvement and can be utilised for multiple studies. Sponsors benefit from having a unified platform for all sites and studies, streamlining monitoring activities without disrupting site workflows or burdening sites.
Site-driven remote monitoring and eISF management: This is a more recent option where sponsors are willing to finance the development of such solutions due to their numerous benefits. These include:
- Increased efficiency and cost savings
- Leveraging existing processes for enhanced productivity
- Real-time access for better oversight and transparency
- Improved communication and collaboration through electronic document exchange
- Centralised data access for tracking and trending
- Reduced compliance risks
- It is also possible to use a single platform across all studies conducted at the site
What’s Next For Remote Monitoring in Clinical Trials?
Over the next few years we are likely to see more and more CRO’s starting to implement remote monitoring in clinical trials. Once some of the challenges that remote monitoring presents are accounted for, then the benefits it provides offer significant boosts to efficiency, recruitment/retention and
- More CRO’s leaning to remote monitoring
- Hybrid solution becoming the norm
- Streamlining of remote monitoring process
- More software developed that will contain the whole remote monitoring process, as a centralised app
- It is expected that remote monitoring plans will undergo revisions, with a focus on realising the long-term benefits associated with this approach, such as improved efficiency, cost reduction, and enhanced data quality.
Conclusion
In recent years, there has been a shift towards implementing remote monitoring in clinical trials, which for some already existed as a secondary solution. However, since COVID-19, CRO’s were forced to think of, and implement, remote monitoring solutions in order to carry on with clinical trials. Even with COVID-19 being less prevalent, remote monitoring still presents many benefits such as more efficiency, cheaper costs and an increase in patient safety.
A hybrid solution that involves remote monitoring the majority of the time, because of the advantages mentioned above, but with participants coming to physical sites when needed, is becoming much more common. This solution offers the best of both worlds.
How Simbec-Orion Can Help With Remote Monitoring
At Simbec-Orion, we are a leading CRO that is experienced in both site management and clinical monitoring. Check our library of case studies to see how we have helped previous clinical trials to streamline their processes and achieve higher quality results.
Get in touch with us today to see how we can help you implement remote monitoring solutions into your clinical trials.
FAQs
What is remote monitoring in clinical trials?
Remote monitoring is a clinical trial, which refers to a workflow where monitors and participants don’t visit a physical site to transfer data and feedback. Instead, the monitoring is done virtually, making use of technology via video calls, file transfer software, or even bespoke custom all-in-one solutions that allow data submission and review. The benefits of this are numerous, helping to reduce costs and increase efficiency.
What is the risk of remote monitoring in clinical trials?
The main risks that remote monitoring in clinical trials presents are technology adoption and data management/protection. The nature of a clinical trial means a vast amount of confidential data is generated, which needs to be protected and stored correctly. HIPAA requires that all personal health information needs to be encrypted when it is transmitted. The remote monitoring solution that is used must make this easy for participants in the clinical trial, who might not be familiar with the software being used.