The COVID-19 world-wide pandemic has forced the clinical trial industry to make rapid changes in order to continue protecting participant safety, privacy, and data integrity. Particularly at clinical sites, research teams have had to restructure their operations according to institutional directives to prevent the spread of COVID-19. In Canada clinical sites have been working towards upgrading electronic medical records and transfer, and the pandemic has forced institutions to speed implementation.
With the resulting new monitoring landscape in mind, this article is a follow-up to the March 2020 article “CRAs Play a Supporting Role in Patient-Centric Trials.” CRAs continue to be key players in supporting a patient centric approach to clinical trials, even as this now comes with new challenges.
Site Initiation Visits (SIVs) are now done remotely via teleconferencing in order to accommodate site restrictions on visitors and connect with site personnel who work from home. The challenge to provide effective training can be overcome by using webcams when available and conducting presentations with smaller groups. During these remote SIVs, CRAs should discuss with site personnel how study assessments and visits will be conducted given institutional restrictions. SIVs are also an opportunity for CRAs to discuss contingency plans in the event of a second wave and further restrictions. A better prepared team will be able to inform their participants of the expectations to attend on-site visits at the start of their involvement so there are no surprises through the course of their study participation.
Additionally, it should be made clear what is acceptable accommodation during the pandemic. For example: can local laboratories closer to a participant’s home be used for routine bloodwork? Does the pharmacy have a process to ship study drug directly to the participant’s home? How will drug returns be conducted to protect both the participant, site personnel, and ensure accountability? Establishing expectations and processes from the outset allows for a smoother participant experience.
Cancer patients, particularly those with advanced disease, rely on access to clinical trials for treatment options and therefore it is essential that recruitment and enrollment into oncology trials continue during the pandemic. All the while, eligibility must be verified to ensure participant safety and data integrity. CRAs have helped sites continue to recruit and enroll participants by communicating expectations for remote monitoring clearly and completely. Moreover, CRAs can guide clinical site teams to find systems and processes by sharing successful methods other sites have put in place to address common concerns.
This positive, solutions-focused teamwork between the CRA and site team ensures there is adequate oversight of enrollment activities.
Treatment and Follow-up Phase
Due to limited on-site access to facilities, CRAs have had to adapt how they review data and interact with sites. In the early days of the pandemic, it was evident that the site personnel did not have the bandwidth to handle source data verification-related requests on top of following up on participant assessments and safety. Moreover, several institutions limited the number of days that research staff could be on-site so it was not possible for research personnel to have access to all the participants’ documentation from home.
Given these constraints CRAs supported their site teams by prioritizing requests through a clear understanding of the limitations the COVID-19 pandemic placed on site personnel’s availability and access to their offices. This approach alleviates frustration and ensures participant safety, and critical data points are addressed promptly.
Presently, more and more institutions in Canada have established the infrastructure necessary to allow virtual and secured source data verification and even virtual review of investigator study files.
Foremost Clinical Trial Participants are People
This pandemic shocked the world, the clinical trial industry and the people that move this industry forward. Throughout the crisis, Scimega CRAs and country leads have kept participant safety at the forefront, viewing new challenges as opportunities to support site personnel as they continue to safely offer clinical trials to their cancer patients.
As the site personnel’s primary point of contact with the Sponsor, CRAs are positioned to best represent the values of the clinical trial team to sites and study participants. When site personnel are advocating on behalf of a patient’s questions or concerns, the CRA is an ally who conveys these concerns to the country lead for further discussion with the clinical trial team.
Now more than ever, site personnel appreciate Scimega CRA’s and country lead’s empathy for their struggle to adapt to a new normal while continuing to move clinical trials forward. Scimega CRA’s are also keenly aware of how this pandemic has placed additional burden on study participants. With a supportive CRO team, site personnel can more effectively adapt clinical trials to suit the needs of their study participants, resulting in a continued access to cutting edge oncology study drugs for participant.
This Niche Canadian Oncology CRO – Consistently Goes Above-and-Beyond
With 23 years unparalleled Canadian oncology experience Scimega Research has an optimal operations design critical to its ability to consistently go above-and-beyond for every one of your studies.
Contributed by: Catherine Simard-Morissette, B.Sc, Clinical Trial Leader