How a Remote Monitoring System Can Benefit Your Clinical Trials
There are many benefits of remote monitoring in clinical trials & there are several factors to consider. Not only do you have to figure out what the study should look for, but you also need to make sure that the data gathered in the study is accurate and reliable.
The COVID-19 pandemic was the tipping point for clinical trials and a blessing in disguise. Traditional clinical monitoring involves visiting the clinical sites and collecting the relevant data. However, now that movement has been restricted for some time, it became hard for sponsors to visits sites where clinical trials were being carried out. This did not lessen the fact that every trial must be meticulously monitored so that the results are accurate and reliable.
Fortunately, technology has been leading the way for some time. Remote monitoring has been the best alternative to carry research during a crisis. In fact, most regulatory bodies have updated their requirements. For example, the FDA released a guidance document in 2011 that prompted sponsors to fine-tune their monitoring plans to the needs at trials, which includes remote monitoring. Similarly, the ISO and ICH have also accepted this new trend and encouraged it in their guidelines.
What is Remote Monitoring?
Remote monitoring involves an offsite evaluation of the clinical site where the trials are being performed. It can be part of centralised monitoring where the sponsor personnel investigates a clinical site in a location away from where the trials are carried out. Like any other type of clinical monitoring, you must identify the potential threats to the success and adjust the methodology as per the requirements.
Methods for Remote Monitoring
Before any data is collected from subjects in a clinical trial, the subjects must consent to share the data with people out of the site. You can use several technologies for monitoring a site remotely, including retrieving and storing critical data. The most common of them include fax, emailing, and file-sharing systems. Other popular systems are using a cloud monitoring system (ELN) and the direct access electronic medical records (EMR).
The EMR is a set of wearable devices that allow a scholar to determine such information as heart rate, blood pressure, temperature and step count. This data is then sent to an electronic record for review.
Each of the methods has merits and demerits. As for the merits, these methods are quite cheap and do not require the users to buy new capital equipment or undergo some extensive training. However, the methods are prone to error. The staff on the site may feed the data wrong, forget to send critical data or errors in the sending process.
To solve these issues, you need a system that allows for collaborative review of data. This way, all the participants and managers of the site can access data, query and raise issues if they find any. It also prevents confusion where more than one person has the right to manipulate data. Everyone can see what changes were made and who made them. It ensures that the final information is accurate and free from human errors and omissions.
Benefits of Remote Monitoring
Using a purpose-built remote monitoring system can bring forth several benefits of remote monitoring in clinical trials. Here are some of them.
Improving Data Quality
In a traditional system, clinical trial associates must individually verify data contained in hundreds of papers at the site for a source data review and verification (SDR and SDV). This may cause some inconsistencies in the review process. All the monitors can access all that from a single repository, making process tracking a lot easier.
Compliance with Legal Requirements
Various regulations touch on collecting, transferring, and manipulating health data, depending on the country you are carrying out the clinical trial. However, most regulation bodies have similar regulations on the quality and privacy of the data. For example, the US HIPAA requires data to be confidential, free from unauthorised manipulation and access. These systems may help achieve that.
In any study, the process of collecting and organising data takes over half of the time. There is usually a back and forth communication between subjects and the team on the ground, which takeslots of time. With a remote monitoring system, you can track new data as it comes in and determines if additional information is required. New staff members also get to work in a predetermined workflow, making it easy to get on board. These activities save time and cost, and streamline the trial process.
Repeated on-site visits may disrupt clinical trial monitoring as the staff on the ground may be required to provide information and make explanations, which causes them to stop temporarily. However, with a system in place, you do not need a monitor to come to verify the data on-site.
Virtual monitoring clinical trial benefits outweighs the traditional ones, especially in the middle of the pandemic. If you are planning clinical research, consider remote-based monitoring using the available technologies for fast, safe data collection and transfer, lower costs and increased efficiency.