If we weren’t working remotely before March 2020, odds are we had to start. Some of us were more prepared to ‘go virtual’ than others. Prior to COVID, there may have been occasional days we worked from home or did things ‘off site’. Few of us, however, contemplated all the nuanced requirements needed to perform our jobs without being in the office or traveling to the locations of study subjects. Regardless of work sector, we had to consider an overwhelming number of logistics. Everyone had to adapt.
In addition to study teams who met challenges when switching to remote work, subjects encountered obstacles that prevented them from attending their study visits. Some are still navigating these logistical challenges. Depending on the study’s protocol-specified procedures, subjects may be able to be monitored remotely via telehealth visits, home health professionals, alternate laboratories, and other options approved by the Sponsor and the site’s IRB. However, the studies that require intensive subject monitoring, investigational product preparation and infusion, specialized labs and procedures, and other more subject-intensive variables are not as easily converted to remote trials.
As a CRO, ProTrials was faced with the need to convert multiple studies from on-site to remote monitoring in a matter of days. We manage a wide variety of studies across vastly different therapeutic areas and in multiple study phases, so the need for flexibility and personalized planning was essential. There was not, and could not be, a one-size-fits-all approach. By design, certain studies lend themselves better to remote monitoring. Some were already remotely monitored as part of their study monitoring plan. But, for those that were not, a determination needed to be made about the capabilities of the Sponsor and each site.
The factors above can vary from Sponsor to Sponsor, study to study, and site to site. They need to be carefully considered before deciding on the best monitoring approach moving forward.
It is equally important to consider a study site’s capabilities for participating in remote monitoring. This can vary greatly within the same study. An individualized approach is often needed.
COVID has pushed many of us outside our comfort zones. We’ve had to think outside the box to get things done – especially when it came to keeping our trials going. As COVID numbers are decreasing, many sites are now seeing trial subjects in office again, on at least a modified schedule. However, based on the successes of remote work, site staff are using what they learned to examine alternate ways to care for subjects and perform studies that will be more efficient for all parties involved.
As we all move forward, incorporating remote monitoring into study monitoring plans, making allowances for telehealth visits, and looking at new technologies that allow for ease of subject participation will continue to increase. At ProTrials, we embrace new technologies, building remote monitoring into our studies as appropriate. We continue to work with each of our clients and sites to determine the most appropriate method to ensure data is reviewed promptly, data integrity is maintained, and subject safety, above all, is not jeopardized. ProTrials – the Clinical Monitoring Experts.