How European Countries are Approaching Pandemic-Era Clinical Trials and Monitoring

Within just a couple of months, the coronavirus pandemic has brutally shaken many industries and companies, jeopardizing their business operations and threatening their entire existence. Adjustments have become inevitable for the clinical trial industry as well. Key regulating bodies (FDA, EMA, MHRA, Ministry of Health of Russia) have been urging sponsors to cancel any on-site visits. New measures are being introduced in many countries, including Russia, Europe and CIS countries, especially when it comes to the interaction of research centers with CRAs, who are the binding link between sponsors and investigators.

How to ensure the continuity of coordination of all the decisions made via online tools, compliance with all the GCP requirements and protocols; these and many other questions were addressed by Julia Stepanchuk, a project manager at the OCT Clinical CRO, and Anastasia Zaitseva, the Head of Data Management at Data MATRIX, a member company of the OCT Group. Both experts shared practical techniques and gave detailed comments on each of the highlighted issues.

Stepanchuk, along with the entire OCT’s clinical team, notes that the sites in all the countries of OCT’s operations (Russia, Ukraine, Georgia, Bulgaria, Latvia, Estonia, Lithuania, Belarus, Moldova, Serbia, Croatia, Spain, the Netherlands) that are not on a lockdown demonstrate high flexibility and willingness to adapt to the new reality. Most of the sites based in Russia that continue admitting and treating patients with acute pathologies are not on a lockdown either. None of the sites refused to participate in remote visits or showed any restraint toward remote interaction with CRAs.

“It is true, that working with sites under these circumstances is more labor- and resource-consuming for the team,” Stepanchuk said. “When interacting with investigators, it takes more time to resolve various issues, especially when it is a new site. Nevertheless, our team has been very quick to adapt to the new reality and keep working hard to ensure the continuity of studies.”

Several measures are also being taken regarding the work of the sites. First, it is necessary to select sites that are ready to work remotely, and those that are ready to conduct face-to-face visits and begin patient recruitment in such difficult conditions. In addition, lockdown risks are being included in the management plan, in cases when a site is in an active patient enrollment stage.

Stepanchuk said, “On our first remote visits we also invited sponsor representatives. This was done to assure a sponsor that the site in question is ready to participate in a proper CRA visit, despite the remote mode.”

It became clear that the introduction of restrictive measures led to the development of a whole range of measures initiated both by research sites and CROs. First, all project plans have been designed with the consideration of the COVID-19 pandemic. For instance, in accordance with the FDA, EMA, and the Ministry of Health of Russia, about 95% of CRA visits run by OCT Clinical are now carried out remotely. Secondly, CROs and sponsors have been developing clear instructions for conducting remote monitoring visits, while clinical teams are being trained on the specifics of conducting such visits.

“Each guideline is developed taking into account the specifics of a project and the number of checks that need to be done in each particular case; steps to be done before, during, and after the visit; what tools are required for a CRA to conduct a proper visit (audio, videos, photo),” Stepanchuk explained. “Prior to a visit, CRAs provide investigators with detailed information on what they need to deliver during the visit.”

In the meantime, the CRAs stress that they have to dedicate more time to such visits, which in the end pays off, because such an approach ensures continuous CRA-investigator communication, and that, in turn, results in faster and more effective resolution of various issues.

During a monitoring visit, a significant amount of time is taken up by the data verification procedure (Source Data Verification, SDV). This is a rather time-consuming procedure, the main purpose of which is to make sure that all the information entered in a CRF (case report form) matches the data from the source medical records. Also important is that, in the light of the pandemic, it became necessary to modify some of the eCRFs and to increase the time needed for remote data verification and query issues. This makes a day-to-day communication mode between CRAs and sites necessary.

“Some of the eCRFs, that were not supposed to include information on additional lab tests, are now being modified to include the entry on COVID-19 tests,” Zaitseva explained. “Though we haven’t encountered such cases yet, COVID-19 positive cases will be coded as adverse events, except when it is a COVID-19 trial.”

Following all the above cases, it becomes obvious that even operating within lockdown and self-isolation, it is possible to ensure the continuity of clinical trials without compromising quality and safety of the involved participants. Also, important to note is that there is a high probability that the situation will make necessary adjustments to the industry, which will be there even after everything is back to normal. It is the task of the clinical research players to stay alert in order to be able to adapt and quickly respond to all the changes, while always being aware of the top priority of clinical research which is to ensure the safety of all involved participants.

Julia Stepanchuk, project manager at the OCT Clinical CRO, and Anastasia Zaitseva, the Head of Data Management at Data MATRIX, a member company of the OCT Group.