Why Real-Time Monitoring is Saving Clinical Trials
Real-time monitoring in clinical trials is gaining ground because monitors do not have to visit the sites to transfer or review data. Data is captured virtually by using digital technology. This means that contract research organizations (CRO), hospitals, clinics, study sponsors, and research directors can see data from almost any location.
One clinical trial differs from the other because of the complexity of the trial and the degree of risk.
Remote monitoring in clinical trials is required to meet a set of minimum standards which include effective and timely monitoring. Those responsible must have the expertise to execute the task. Here are the components of real-time monitoring in clinical trials.
How Clinical Trials are Monitored
Clinical trials have evolved in ways necessary to protect patient safety. The pandemic has had the biggest influence on new regulations, technology, and monitoring methods. Below are the different ways to monitor clinical trials.
The traditional method involves in-person evaluations conducted by representatives or personnel at the investigation site. This approach is used in the early phases of clinical trials, mostly in human studies that are characteristic as high risk. This approach ensures accurate data entry and that it can be verified against a source of data. On-site monitoring visits are categorized into initiation visits, interim visits, and a final visit. After every visit, a report is required from the personnel.
This method involves conducting monitoring activities away from the investigation site. Remote monitoring in clinical trials requires documents to be delivered to the clinical research associate (CRA) through fax or mail, and conducting source document verification. The trial data is constantly monitored so the study team can identify missing data and deviations that require immediate action. Remote monitoring allows the study team to resolve concerns or confusion before they develop into larger problems.
This approach involves analytical evaluation conducted by representatives or sponsor personnel at a centralized location which is different from where the clinical investigation was carried out. Researchers collect data and case report forms. The case report forms notify researchers that they need to address a problem in the study.
Requirements for Real-Time Monitoring in Clinical Trials
Monitoring patient safety is critical while performing clinical studies. It is conducted by an expert who is independent of the trial. Safety monitoring requires immediate review of adverse events and an immediate response. Sponsors and other stakeholders are encouraged to explore effective monitoring strategies that will ensure a more risk-averse approach for real-time monitoring and remote monitoring in clinical trials.
Clinical trials should be conducted as per GCP (good clinical practice), and they should conform to regulatory requirements.
To ensure remote monitoring in clinical trials is effective, a risk assessment is performed and included in the monitoring plan. A monitoring risk assessment:
protects the welfare, rights, and safety of the participants.
requires quality and integrity of the provided data.
The monitoring plan is required to allow flexibility which can include the use of on-site monitoring in case any problems arise. The risks and nature of the trial determines the design of the monitoring plan.
Advantages of Real-Time Monitoring
It saves time. On-site monitoring or traditional monitoring processes can be a time burden for both the sponsors and the site monitors. Remote monitoring in clinical trials has minimized the travel and communication delays, thus increasing the overall speed of the trial. Real-time monitoring allows monitors to access data within seconds and as frequently as needed. By using less time, the monitor can focus their attention on other aspects of the clinical trials, and this will result in better quality trials.
It provides immediate information any time. The technology systems used in remote monitoring include features that allow streamlined communication. They include dashboards, email, and in-app messaging. Information can be accessed at any time and from any location as long as the device is connected to the internet.
It makes independent monitoring possible. Real-time monitoring platforms allow independent monitoring by monitors and sponsors. All information is available to those who have access. Independence is crucial since monitoring can be conducted outside regular working hours. This increases efficiency and effectiveness. It ensures credibility as well as control for clinical studies.
It eliminates the need for paperwork. Clinical trials have always been inconvenienced by the hassle of paperwork. Traditional monitoring uses paper-based methods, which limit the ability for repeatable processes making them less efficient. It is burdensome to physically store and organize large quantities of research documentation. New technology drives real-time monitoring. Real-time monitoring can be built into a process all at once, and data can be duplicated, and monitoring can be executed only by a few clicks. The user can create customized document templates for clinical studies. These documents can be duplicated across other sites and studies, and they can be stored without the need for physical space.
It notifies you of temperature excursions. By transitioning clinical studies into technology platforms, real-time monitoring can be done without physical assistance. Notifications and system alerts can be programmed for site activity so monitors can immediately respond to excursions. This makes managing trial activities much more efficient as well as effective.
The clinical supply chain of investigational medicinal products (IMP) is complex. Starting from designing and packaging kits to reaching the patient, safety is of utmost importance. Therefore, temperature management of IMP is critical to ensure the patients’ health is not jeopardized. Real-time monitoring and remote monitoring in clinical trials provide convenience to the participants and the monitors by eliminating or decreasing the need for site visits and travel.
Temperature monitoring is important for biological and chemical medicinal products because it ensures product integrity throughout their lifecycle. ELPRO is a global leader in environmental data monitoring solutions and GxP services. With over 30 years of experience, its intelligent hardware and software technology has been used by the world’s leading companies to monitor their critical assets throughout the entire cold chain.