It is hard to conduct the on-site clinical trial monitoring due to travel obstruction and interruption of clinical trials. The alternative is to use telehealth monitoring, which is meaningful, and now the cost-effective and time-saving mode of telehealth monitoring is gradually becoming popular. Telehealth monitoring in clinical trials means that monitoring personnel will not visit the site to transmit and view data. Instead, data monitoring can be done virtually. By using digital technology, doctors and patients can view monitored data from anywhere.
Not only the trial monitor is remote, but also the patient, which means that we are conducting a completely remote clinical study. And remote monitoring benefits greatly, mainly real-time and real-world data collection and monitoring. It is important to understand the meaning of the terms "real world" and "real-time" and their relationship with telehealth monitoring.
If clinical telemedicine is used to monitor the clinic, but the data continues to be collected from the patients on the site, the data may not accurately reflect how the product works in the real world. On the contrary, in the virtual clinical trial environment, people are monitored in their daily lives when both the patient and the trial monitor are in remote locations, which is called the "real world". With the collection of these data, it is almost immediately "real-time" electronically transmitted back to the test monitor. It is this combination of real-world data and real-time transmission that changes the rules of the game, because it provides researchers with better insight, not only in terms of efficacy in the real world but also in terms of product compliance and patient behavior.
As telehealth monitoring constantly monitors trial data, doctors can immediately identify missing data and detect any strange outliers so that they can take quick action when needed. For example, if a patient forgets to complete some problems in a timely response to his or her doctor, the doctor can contact the patient to solve these problems before suspecting whether the condition is more serious. For on-site monitoring, the staff will not be aware of the gap unless the patient can personally report the protocol compliance. And it is often too late to correct patient behavior, with data loss or memory bias. Therefore, telehealth monitoring helps to minimize the data gap.