Remote Monitoring in Clinical Trials

With travel hampered and clinical trials disrupted, it’s difficult to conduct on-site clinical trial monitoring. The alternative — remote monitoring — has always made sense, but now this cost-effective, time-saving model is rightfully gaining steam. Remote monitoring in clinical trials means monitors don’t visit the site to transfer and review the data. Instead, the data monitoring is done virtually. With the use of digital technology, CROs and study sponsors/stakeholders can see the data from wherever they are located.
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Remote Patients & Remote Monitoring: A Game-changing Combo

In ObvioHealth’s case, not only are the trial monitors remote, but the patients are as well, meaning we are conducting fully remote clinical studies. This opens the door to a slew of advantages – primarily real-time and real-world data collection and monitoring. It’s important to be clear about what the terms “real-world” and “real-time” mean and how they relate to remote monitoring.

If clinical trial monitoring is conducted remotely, but data continues to be collected from patients at a site, the data may not reflect an accurate representation of how the product works in the real world. Instead, in a virtual clinical trial setting, where both the patients and the trial monitors are remote, people are monitored as they go about their daily lives – what we call “the real world.” As this data is collected, it’s electronically transmitted back to trial monitors almost instantly, in “real time.” It’s this combination of real-world data and transmission in real-time that’s a game-changer because it provides researchers with improved insights, not just on efficacy in the real-world, but also on product compliance and patient behaviors.

Real World Data

Remote study subjects follow the protocol from the comforts of their homes – perform the study tasks, fill out their daily diaries – and this real-world data is almost instantly available to trial monitors.

Real Time Monitoring

Because the patients' data is accessible so quickly, the study team can respond to operational challenges, meaning researchers can often avoid potentially time-consuming, expensive detours.

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Real World Data

Remote study subjects follow the protocol from the comforts of their homes – perform the study tasks, fill out their daily diaries – and this real-world data is almost instantly available to trial monitors.

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Real Time Monitoring

Because the patients' data is accessible so quickly, the study team can respond to operational challenges, meaning researchers can often avoid potentially time-consuming, expensive detours.

Our Virtual Platform

Enables Constant Communication Between the Study Staff and Participant

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What does Remote Data Monitoring in Clinical Trials Look Like?

For ObvioHealth clients, data from patients is viewable in an easy-to-read dashboard. This digestible format provides an overview of the trial data, highlights any outlier data, and allows the trial monitor to dig as deeply as desired.

An example of what a customized study dashboard may look like for an ObvioHealth client (on tablet).

Clients can track recruitment, enrollment, compliance, and study progress on an hourly, daily, or weekly basis… whatever suits them. In this way, both researchers and sponsors/stakeholders can spot issues like protocol deviations or adverse reactions to intervention(s) as they occur, allowing them to read and react to situations in real-time. This ability to identify problems quickly is an important advantage of remote monitoring in clinical trials.

Key Features of ObvioHealth's Remote Data Monitoring in Clinical Trials

Validated Scales: Our dashboard displays a week over week view of  efficacy using validated scales. These charts are updated in real-time, so you’re always aware of how the study product is performing.

Engagement & Compliance: Always be in-the-know when it comes to protocol and product adherence. A review of the study’s stats allows you to see how many participants have dropped out, how many remain in the study, and where your compliance rate stands. This makes it easier to search out and correct issues before they become problems.

Customized Alerts: Potential safety, compliance, and engagement complications are quickly identified, permitting the remote clinical research team to outline the necessary action steps to resolve various pain points. Does a participant need to be reminded to complete a study activity? Should a participant stop consuming the study product? Is medical attention required? Does a participant need to be removed from the study?

Learn More About Our Remote Clinical Studies Platform

Speak to our clinical operations team today about remote monitoring for your clinical trial.

Remote Site Monitoring in Clinical Trials helps Minimize Gaps in Data

Because the trial data is constantly being monitored, the study team can immediately pinpoint missing data and detect any odd outliers, allowing for quick action, if needed.

For example, if a patient has forgotten to complete study tasks, the study team can reach out to address and resolve confusion or concerns before they become trends. For studies with on-site monitoring, staff is often unaware of gaps until a participant can report protocol compliance in-person. At this point, it is often too late to course-correct patient behavior, the data is lost and/or recall bias is more likely.

Course Correction

A sponsor can lose anywhere between $600,000 to $8 million for each day product development and launch is delayed. But when remote monitoring allows the study team to see the data in real-time, issues within the study are usually identified quickly. This allows the researchers to remedy the problems before they become extraordinarily burdensome and expensive.

AE Detection

Adverse events are spotted sooner in trials with remote monitoring because access to the data occurs faster.In ObvioHealth’s trials, a patient has 24/7 access to a member of the study team to report symptoms if needed. In the site-based approach, communications are limited, and AE/SAE can easily go unnoticed/unreported. This means trials with remote monitoring are safer for patients.

Data Cleaning

As participants record their data using the ObvioHealth app, errors are inevitable. Sometimes we’ll see an accidental extra “0” added to a number. These errors must be “cleaned up” as to not negatively affect data interpretation.In many conventional designs, the participant must travel to the site location to relay data. It is only at this point that a study doctor can identify and clean up errors. The study staff is constrained to catching the mistakes when transferring the data from a source document into a database. Even then, there’s potential for the clinical research staff to commit additional errors during data transfer.In a virtual or hybrid trial design that employs remote monitoring, the participant inputs data that is directly transferred into a database. No need for manual data transfer, and no added risk of error. Instead, the study staff can monitor data as it comes in, ensuring that mistakes are quickly detected and resolved. Keep in mind that this process may even be configured to alert the staff to data outliers; no need to comb through each data set to uncover errors

Examples of Course Correction in Remote Clinical Research

Recruitment
Challenge: Constraining inclusion/exclusion criteria caused a high screen fail rate..

Advantages of Remote Monitoring: By observing how participants registered for a trial in real-time, ObvioHealth project managers were able to analyze demographic trends in real time and pivot when needed. When one racial demographic began to heavily outnumber another, the study team quickly reconfigured the recruitment strategy to prioritize regions with other high-density ethnic populations. With no site visits, patients were able to participate in the study from anywhere (even remote islands). The real-time, remote recruitment monitoring made it easy to pivot to new geographies.

Enrollment
Challenge: Constraining inclusion/exclusion criteria caused a high screen fail rate..

Advantages of Remote Monitoring: Because the research staff saw the enrollment data in real-time, they quickly pinpointed an apparent reason for screen fail. This prompted the study team to request a protocol amendment from the IRB, making a slight tweak to inclusion/exclusion criteria and changing the wording for some of the prescreen questionnaires. Although a protocol amendment was required, this ultimately saved the sponsor time and money on recruitment and enrollment and allowed researchers to pinpoint criteria that were impeding recruitment during prescreening.

Patient Reporting
Challenge: A patient-reported persistent headaches during a menopause study.

Advantages of Remote Monitoring: The PI immediately reached out to the participant via the app's instant messaging feature to evaluate the woman’s symptoms. In this situation, there was a need to determine whether the study product was the root cause of the AE. Due to remote monitoring, the study team recognized the possible AE, as the headaches were occurring, and the patient received immediate care and communication from the PI.

Data Collection
Challenge: Patients having difficulty adhering to the protocol.

Advantages of Remote Monitoring: Digital communications and reminders can combat faltering engagement and compliance. If a participant forgets to complete a study activity, the study team will see this lapse immediately and reach out to ascertain the nature of the error and correct it. In a traditional study with on-site monitoring, these lapses often go unnoticed.

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The Hybrid Model: Remote Site Monitoring in Clinical Trials

Not ready to go fully virtual with your clinical trial? A hybrid clinical trial employs virtual aspects, but might include a couple of site visits as well. In between site visits data collection occurs virtually through EPRO. To achieve remote monitoring in these instances,  the data from the site should filter into the same system with the patient reported data.

An ObvioHealth Case Study

This remote site monitoring clinical trial assessedthe safety and efficacy of rice vinegar as a treatment for pre-hypertensive adults, and those at high risk for cardiovascular disease.
The study included four site visits, and in-between site visits the patients used ObvioHealth’s app for ongoing data collection.

Challenge

This remote site monitoring clinical trial assessedthe safety and efficacy of rice vinegar as a treatment for pre-hypertensive adults, and those at high risk for cardiovascular disease.
The study included four site visits, and in-between site visits the patients used ObvioHealth’s app for ongoing data collection.

Solution

The two sites, located in Atlanta and Houston, used eCRF, which integrated into the ObvioHealth platform. All patient reported data and data from the sites was viewable in real time to the sponsor and study staff using ObvioHealth’s dashboards.

Results

By monitoring enrollment data reported from the sites in real-time, ObvioHealth was able to pinpoint an eligibility roadblock and propose a quick solution. Remote monitoring allowed for course correction during enrollment, which curtailed the wasting of resources. Enrollment was delayed by only a few days, as opposed to weeks or months had the issue not been identified quickly. Just before the completion of enrollment, ObvioHealth met with the client, who expressed appreciation for the teams’ responsiveness and adaptability.  

Enhancing Remote Monitoring in Clinical Trials through Device Integration & Artificial Intelligence

The monitoring of real-time, real-world data can be improved through inclusion of instruments like fitness trackers, medical devices, and other digital therapeutics. It seems patients are familiar with the concept of device integration (a good sign for researchers). The world has already embraced wearables; just look at the popularity of smartwatches and fitness trackers. These wearables collect health-related information and are often linked to an app within the users’ smartphone where the data is transferred and stored. When enabled, these devices can transmit data back to the study team, allowing real-time, real-world monitoring.

Passive Data Collection and Remote Monitoring in Clinical Research

When a patient spends time entering data, this is viewed as “active data.” When a patient’s health is monitored in a manner that doesn’t require manual data entry, this is called “passive data.” This type of data is not influenced by patient availability or perception. Instead, it is collected from the wearable, and the raw, unbiased information is sent directly from the device to a centralized database where researchers can monitor it remotely.

Learn More About Our Remote Clinical Studies Platform

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