Lessons Learned: site monitoring amid the height of the pandemic
By: Agnieszka Stawicka, Clinical Team Manager — Regional Clinical Operation Services
The ever-evolving COVID-19 pandemic and recommended safety protocols that stemmed from it forced all of us to change our well-established routines. At KCR, we instantly knew a swift shift in approach and the adjustment of our monitoring activities would enable us to fulfill obligations and ensure proper site oversight during these unprecedented times.
While all KCR Clinical Operations Managers were working diligently to perfect remote monitoring processes and develop strategies for continued site oversight, at the end of the day, success laid in the hands of CRAs and researchers at Clinical Sites. After months of successful monitoring during the COVID-19 pandemic, we have insights to share from our expert CRA teams across all KCR’s operational regions: North America, Western Europe, Central Europe and Eastern Europe.
Site Participation: maintaining patient visits & keeping up with monitoring
This new reality not only urged CROs and Sponsors to seek alternative methods and technologies, but it also encouraged Clinical Sites to search for new methods to continue research. This was not a one-sided effort from Sponsors/CROs to keep patient visits and monitoring activities going, but truly all parties were involved in ensuring patients treatment and Clinical Studies continuity.
As COVID-19 emerged, all parties involved in the study noted benefits from technology advancement. Accommodating the impact of lock-down was certainly easier for Clinical Sites, where processes for remote patient visits, telemedicine and remote access to Electronic Medical Records were already established.
For sites without remote capabilities, we observed prompt actions to ensure their implementation in a swift yet compliant manner. Sites worked to seek alternative contactless methods of collaboration extended to patient treatment as well, where telemedicine and phone contacts were implemented for procedures which did not require physical presence.
While EMR is common in the United States, it is not the case in most of Europe, although sites actively work to stay compliant with protocols and monitoring obligations. Sites have remained engaged to provide information and required documents, as well as to spend time on the phone/video with CRAs to enable remote oversight. Additionally, sites have worked on implementing sanitary protocols and adjusting work spaces to enable patients and CRAs onsite visits in accordance with health authorities’ guidelines. Despite limitations, the rate of onsite visits continuing in Europe was positive.
Patient’s first
Ewa Hartyniuk-Kempka, KCR Senior Clinical Research associate from Poland expands on this, noting, “Site Staff and Institutions understood that monitoring activities had continue, but the patient’s safety, site’s personnel safety, and compliance with laws and regulations are the priority”.
Though uncertainty and last-minute changes often disrupted day-to-day activities, it was crucial to provide reliable information to Sponsors about the situation at the site in a timely manner. While CRAs and sites were doing their best to ensure timely flow of information about study progress, site preparedness and proper oversight, there certainly were obstacles hard to overcome. It was common for sites to reduce their staff working hours or transition them to work-from-home, so they were not always able to get information from their offices, and while working continued to focus on priorities related to securing patient visits.
These disruptions caused delays in the delivery of required information. It was particularly challenging as CRA team had to balance immediate study needs with the preservation of relationships with our Sites, respecting the time they needed to adjust and re-establish processes at the site. Site teams were eager to ensure visible continuity of clinical research and monitoring activities, but patient’s always come first. Kasey Worklan, a CRA team member in the US, added “Once sites had policies and guidelines put into place, the staff were more amenable to focusing on the study again.”
Preparation is key
CRA, Lea Erhardt, Germany, shares the recipe for successful site management as “More preparation and more follow-up”.
One of the major lessons learned for all CRAs is the importance of good, forward thinking preparation for the visit. Across all countries, team members shared that diligent preparation and information provided to the sites in advance worked to get the most from the visit and enabled site team members to prepare as well. It was crucial to make remote monitoring successful, but was also essential for onsite visits, where interaction with the study team and access to certain areas were limited. This will remain routine for all CRA teams going forward, irrespective of monitoring visit setting. Diligent preparation also helped keep and strengthen collaboration with the site, as showed respect to site team workload and limited capabilities during COVID-19 lockdown.
It is important now for Sites to consider this new information while planning future resources, where remote monitoring and remote site management might be utilized long-term. What was easily accessible at sites for CRAs without engaging site team members, now requires steady involvement of site personnel. Making documents available in an electronic format and being prepared to spend time on video conference or phone to clarify issues and observations simply requires additional time and efforts.
End of the onsite visit era?
While we have the technology to enable and advance all aspects of remote Clinical Monitoring, and although there are benefits to remote monitoring, there are still areas where onsite presence is hard to be replaced. Understanding the site processes, verifying them in practice and most importantly, building relationships and trust, is hard to achieve without face-to-face interaction. Having good relationships with sites and understanding their routines makes for easier collaboration despite COVID-19 limitations.
Maxim Pogonets, with insight from monitoring in Russia, emphasized: “I have positive experiences with my sites for all aspects of remote collaboration — but this is a question of good communication. It is easier to cooperate with the familiar sites.”
We all are looking forward to meeting with Study Teams onsite again!
