The landscape of clinical trials is becoming ever more multifaceted due to increased intricacy, regulatory rigidity, and the growing costs of conducting studies. The effort to combat these constraints has laid the foundation for technological maximization. Companies have been tasked with balancing study costs and timelines, while ensuring patient safety and complying with regulatory demands. This has increased the need for remote-based monitoring, not to be confused with risk-based monitoring. Alongside this, patient recruitment is still one of the greatest challenges faced in clinical research. Unlike site-based studies that recruit only patients treated at particular pre-selected sites, remote centered studies can also include patients without regard to proximity to a site.
What is remote-based monitoring? It’s an approach in which clinical trial professionals can remotely review the data, and ensure that their site visits are spent efficiently. If the data is collated in an eSource format, this smart monitoring strategy can advance the quality, lower the cost, and enhance the swiftness of clinical trials. For large studies, however, it’s not always feasible – and can be costly – to have monitors to go to sites. Therefore, it is more efficient to conduct monitoring remotely as it’s also in keeping with a risk based approach.
Remote-based monitoring is usually linked to treatment of chronic health care conditions such as diabetes. Patients that suffer from such disease management conditions are increasingly being monitored outside of the clinical environment. In this instance, remote-based monitoring is favorable as it is very compatible with the patient-centric lens that is becoming ever more important in this field. Patient centricity remains one of the biggest trends currently, and this is shaping the way trials are viewed and conducted.
As patient and advocacy groups continue to grow worldwide, it is becoming more important than ever to incorporate them into the drug development process. The industry is known for being slow to adapt to change, but with the strengthening of remote-based monitoring across many trials, we are seeing an embrace of innovation in order to meet the needs of patients and their families. It also gives clinical research associates (CRAs) and other clinical staff more time to focus on the study itself rather than on the operational constraints.
A clear advantage of remote-based monitoring as stated previously is that it maximizes patient availability and enrolment in clinical trials. Patient recruitment is usually seen as one of the tedious aspects of the clinical trial process and can have serious implications on trial completion. This method also had the ability to affect patient retention as dropout rates are a common aspect of this process; most dropouts occur due to travel inconveniences, and this can be mitigated by the use of remote-based monitoring. There is also an advantage in terms of data quality, as the process allows for data to be accessed instantaneously through the electronic systems. Data transfer is also then much more secure.
Despite the progressive contribution remote-based monitoring brings to clinical trials, there are still many challenges it presents to industry. One of the main challenges is to ensure the data is transmitted from patient monitors to doctors and clinicians efficiently and securely. It is paramount that the volumes of data which is transmitted from continuous patient monitors through cell networks to cloud-based data warehousing systems. Consequently, guaranteeing data security and obeying the Health Insurance Portability and Accountability Act (HIPAA) are two of the chief challenges facing software designers and developers in this space. Another challenge industry is faces is coping with and scrutinizing the mountains of data generated through this method of monitoring.
If you look from a site perspective, the use of remote-based monitoring can adversely affect the relationship with the sponsors, and this dynamic is very crucial, not only for the communication and understanding of the protocol, but for the success of the trial. So as remote-based monitoring seeks to improve certain parts of the process it may also exacerbate other challenges, such as trial design.
On the whole remote-based monitoring embodies the future of patient engagement, and this is integral if we want clinical trials to be a global and contemporary industry.