Remote monitoring: Your clinical trial control center
27-07-2023
What advantages does it offer over traditional monitoring?
With remote monitoring, both investigators and sponsors can detect problems such as protocol deviations or adverse reactions to any interventions as they happen, allowing them to react to these situations in real-time. This capacity to identify problems quickly represents a significant advantage of remote monitoring in clinical trials. Remote site monitoring helps minimize data gaps since they are constantly monitored. The study team can immediately identify missing data and detect any outliers, which allows them, when necessary, to act quickly and communicate with the patient to address and resolve any questions or doubts they may have before they are converted into trends.
Increasingly, clinical trials include wearable devices that gather information related to the patient's health and are often connected to an application in the users' telephone, where the data are transferred and stored. These devices can transmit data to the study team when active, allowing for real-time monitoring. With this device, the patient does not have to spend time entering data (active data); instead, data is transferred automatically and is not influenced by the patient's availability or perception (passive data). Unbiased and unprocessed information is directly sent from the device to a centralized database, where investigators can review it remotely.
With RM, adverse events can be detected earlier because data access is faster. Patients have access 24/7 to a study team member in case they need to report any symptoms. In the site-based approach, communications are more limited, and adverse events can go unnoticed or unreported. Therefore, remote-monitored trials can be considered safer for patients.
In the case of clinical trials assessing how a product works in patients' daily life, everything is created in a virtual clinical trial setting, where both the patients and the study monitors engage remotely. People are monitored while conducting their activities of daily living in what we call "the real world." As data are gathered, they are electronically transmitted to the trial monitors "in real-time." This type of analysis provides enhanced information to the investigators, not only about real-world efficacy but also about product compliance and patient behavior.
What does RM include?
Validated scales that show a weekly view of the efficacy. These graphs are updated in real-time, which means that the performance of the study product can always be analyzed.
Commitment and compliance data provide information on adherence to the protocol and the product. A review of the study statistics showing how many patients have withdrawn, how many remain in the study, and their compliance rate. This tool helps search and correct certain situations before they become an issue.
Customized alerts regarding safety, compliance, and commitment, allowing the remote clinical research team to describe any actions required to resolve weaknesses. These include reminding a patient to complete a study activity, telling a patient to discontinue the study product, indicating the need for medical attention to any participants, or the need to withdraw a patient from the study.
With remote monitoring, both investigators and sponsors can detect problems such as protocol deviations or adverse reactions to any interventions as they happen, allowing them to react to these situations in real-time. This capacity to identify problems quickly represents a significant advantage of remote monitoring in clinical trials. Remote site monitoring helps minimize data gaps since they are constantly monitored. The study team can immediately identify missing data and detect any outliers, which allows them, when necessary, to act quickly and communicate with the patient to address and resolve any questions or doubts they may have before they are converted into trends.
Increasingly, clinical trials include wearable devices that gather information related to the patient's health and are often connected to an application in the users' telephone, where the data are transferred and stored. These devices can transmit data to the study team when active, allowing for real-time monitoring. With this device, the patient does not have to spend time entering data (active data); instead, data is transferred automatically and is not influenced by the patient's availability or perception (passive data). Unbiased and unprocessed information is directly sent from the device to a centralized database, where investigators can review it remotely.
With RM, adverse events can be detected earlier because data access is faster. Patients have access 24/7 to a study team member in case they need to report any symptoms. In the site-based approach, communications are more limited, and adverse events can go unnoticed or unreported. Therefore, remote-monitored trials can be considered safer for patients.
In the case of clinical trials assessing how a product works in patients' daily life, everything is created in a virtual clinical trial setting, where both the patients and the study monitors engage remotely. People are monitored while conducting their activities of daily living in what we call "the real world." As data are gathered, they are electronically transmitted to the trial monitors "in real-time." This type of analysis provides enhanced information to the investigators, not only about real-world efficacy but also about product compliance and patient behavior.
What does RM include?
Validated scales that show a weekly view of the efficacy. These graphs are updated in real-time, which means that the performance of the study product can always be analyzed.
Commitment and compliance data provide information on adherence to the protocol and the product. A review of the study statistics showing how many patients have withdrawn, how many remain in the study, and their compliance rate. This tool helps search and correct certain situations before they become an issue.
Customized alerts regarding safety, compliance, and commitment, allowing the remote clinical research team to describe any actions required to resolve weaknesses. These include reminding a patient to complete a study activity, telling a patient to discontinue the study product, indicating the need for medical attention to any participants, or the need to withdraw a patient from the study.
