The COVID-19 pandemic proved the clinical trial industry can rally quickly to develop vaccines in record time. It also may have proven that remote monitoring of study sites is here to stay.
“Remote monitoring is not going away,” says Suzanne Sullivan, RN, CCRA, manager of Clinical Research Services for NAMSA. She’s in charge of a team of clinical research associates (CRAs) who successfully and rapidly pivoted from onsite to remote monitoring as the pandemic upended clinical trials early last year. “Our team did a phenomenal job; we didn’t drop the ball or lose clients,” Sullivan notes.
Sullivan and Nicole Tierney, CCRA, BA, a principal CRA with NAMSA, will share observations about what worked and other lessons learned during the ACRP 2021 virtual conference’s round of sessions in May.
Communication and flexibility are obvious ingredients in the secret sauce of success, Tierney says. However, she suggests that planning ahead is at least as critical a component because it allows practitioners to be proactive rather than reactive, even when something as mammoth as a global pandemic enters the operational picture.
While everyone is eagerly awaiting the day when COVID-19 is more of a memory and less of an obstacle in day-to-day trial conduct, Tierney implores sites to “plan ahead and assume remote monitoring will be involved” in trials from now on in some fashion. Even as some studies have returned to onsite monitoring, Tierney notes the situation could change again in a heartbeat. “We have to be ready to use remote monitoring again,” even if that’s not in the initial study plan, she says.
For smaller sites and those with little or no remote experience, that means getting together now with their information technology (IT) department to set up the technology needed, Tierney says, including having a cloud-based file sharing system and establishing remote communication tools such as Webex and Zoom. “Not doing this has been an issue with some sites in the past, where they haven’t run things by their IT department” to make sure they can handle the technological requirements of leveraging remote monitoring, Tierney warns.
Meanwhile, Sullivan stresses the importance of putting thought and care into developing realistic contracts and budgets. “Sites are needing to charge more in many cases because remote monitoring is taking more time” than they had anticipated, she says. That’s especially the case if both sides haven’t worked out clear, understandable policies for giving trial practitioners proper access to electronic medical records (EMRs), she notes. Often, the process is not standardized from one site to another, she adds.
“One site might have an easy, single-page confidentiality form to sign to gain EMR access, while another might have a complicated, seven-page document requiring multiple signatures,” Sullivan says. “It does everyone a lot of good to have that area cleared up from the very beginning.”
Author: Michael Causey