In March 2020 with the onset of the COVID-19 pandemic, most clinical research across Ontario and Canada stopped abruptly. As the province begins to reopen, hospitals are tasked with the challenge of resuming clinical activity and clinical research in a safe and responsible way. Over the past few months, the University Health Network (UHN) has taken on this challenge with great success. UHN is one of many hospitals across Ontario working on solutions to allow for safe and effective clinical research in our new reality.
Clinical Trials Ontario spoke with a few of the key players at UHN responsible for rolling out the restart of clinical research at their institution, including Dr. Harry Janssen, Chair of UHN’s Clinical Research Restart Committee, Katie Roposa, Director of Research Quality Integration, and Mike Voth, Manager of Research Quality Integration.
UHN’s path to restarting clinical research
When discussions regarding the restart of clinical trials began, UHN formed the Clinical Research Restart Committee. Comprised of about 25 people from UHN’s four hospitals (Princess Margaret Cancer Centre, Toronto General Hospital, Toronto Western Hospital, and Toronto Rehab), the committee includes research coordinators, research operations leaders, clinical scientists, patient representatives and others. As many trials run within the clinical areas across the hospitals, clinical research restart had to be balanced with the restart of clinical activity. The committee worked in lockstep with UHN’s Clinical Activity Working Group and adopted the same three-phase system to ensure a smooth, integrated restart in both areas. “It has been great to see everyone from across UHN, who often work in their own silos, come together to solve the issue of clinical research restart”, said Dr. Janssen, who in addition to chairing the Clinical Research Restart Committee also serves as Professor of Medicine at the University of Toronto, Chief of Hepatology at Toronto General Hospital and Director of the Toronto Centre for Liver Disease.
To begin the research restart process, the Clinical Research Restart Committee first came up with a set of guiding principles to inform their approach. “This set of principles was key to ensuring that everyone across UHN was on the same page,” said Katie Roposa, who was a key actor in establishing the committee through her role as Director of Research Quality Integration.
Next, the committee created an online assessment form to be filled out by Principal Investigators (PIs) across UHN. Part of the form asked basic questions about the feasibility and safety of restarting studies that had been suspended, and PIs were required to answer ‘yes’ to each one in order to qualify for restart. Questions considered key criteria such as: ‘Is the REB approval in place’; ‘Are there plans in place to ensure safe physical distancing of staff and participants?’; ‘Has the sponsor agreed to the restart including any modified activities such as remote participant visits, use of external labs, etc’; and ‘Have you ensured access to adequate personal protective equipment (PPE) for staff and participants?’.
The second part of the form helped UHN work with PIs to prioritize which studies which would restart in phase one, two or three of the restart process. With PIs answering on a scale of 0 to 3, it included questions such as: ‘Does the study require services above standard of care such as inpatient admission or additional testing?; ‘Does this study investigate an unmet clinical need for patients including a potentially lifesaving intervention?’; and ‘Does the study protocol add additional risk to UHN staff of acquiring COVID-19?’.
Using UHN’s existing clinical research department and division structure, each division appointed a Clinical Research Division Lead (CRDL), who was responsible to review submitted forms. The CRDL worked collaboratively with each PI to jointly decide when their study would restart. Phase 1 was successfully launched on June 20th and Phase 2 began on July 20th.
Overcoming key challenges
With a high level of collaboration among researchers, staff, patient partners and study sponsors, UHN was able to enact their clinical research restart plan in a remarkably short timeframe. But as with any process implementation, there were some hurdles along the way.
Balancing act: Balancing central coordination and oversight with autonomy for each clinical research division to review its own studies was a challenge faced by the committee during clinical research restart. Ultimately, they decided that CRDLs would review their PI’s online forms and assess the suitability of restart given the local context of their clinical area. The CRDL’s report to one of five Site Leads, one for Toronto General Hospital, Toronto Western Hospital, the Joint Department of Medical Imaging, Toronto Rehab (KITE) and Princess Margaret, who are all part of the Clinical Research Restart Committee. The Site Leads have a hospital-wide perspective and can advise CRDLs and make decisions in case of appeals from PI’s or other problems such as studies done across Divisions or even across Sites.
“Autonomy was important to efficiently making informed decisions about which studies should start and when,” explained Mike Voth. “Some areas of UHN are more conducive to allowing things such as increased foot traffic and the Clinical Research Division Leads were in the best position to make that judgement.”
To allow for central oversight, all forms were entered into a central repository using the REDcap system. This has enabled the committee to track the number of studies restarting in each phase, the number of additional staff needed on-site, and the number of participant visits at the hospital for in each study. “The ability to capture this data will be really powerful moving forward, as we have never had such a strong, clear view into our clinical research activity,” commented Dr. Janssen.
Remote monitoring: Another challenge was establishing remote monitoring access for study sponsors. To restart clinical trials, study sponsors must be able to conduct monitoring of the trial. “We were eager to implement remote monitoring to ensure that we could continue to limit the amount of non-essential visitors to the hospital,” said Roposa. Prior to the COVID-19 pandemic, UHN did not have systems for remote monitoring in place. However, through collaboration with study sponsors, they were quick to adapt. Immediately, UHN established interim remote monitoring access through Microsoft Teams screen sharing. They have now established direct remote access using the system Citrix Systems which will allow study sponsors direct, secure, remote access to electronic medical records.
Communication: Clear communication of the clinical research restart plan, both internally and to the community, was vital to UHN’s success. Extensive communication regarding the restart plan was done through email and virtual town halls delivered through Zoom and YouTube. These town halls mirrored the same format as UHN-wide town halls to ensure that information was being delivered in a familiar way. Several webinars were also held for Clinical Research Division Leads to walk them through the online form assessment process.
The future of clinical research at UHN
Members of the Clinical Research Restart Committee agree that the COVID-19 pandemic will shift the way UHN operates moving forward. “Our normal is going to change,” said Roposa. “This crisis has surfaced a lot of new challenges and has highlighted things we now know we can do better.” Prior to the pandemic, UHN had been developing a centralized oversight process to better integrate clinical research with clinical activity. COVID-19 has accelerated those initiatives.
“People say, never waste a good crisis. This is definitely true here,” said Dr. Janssen. “It was initially difficult to get the groups from across UHN together, due to each hospital having its own identity. But it will be beneficial for us to keep a clinical research committee intact post-COVID to continue to navigate our research community in a more integrated way.”
Remote activity may also become increasingly important moving forward. “The ability to do remote monitoring, remote consent, virtual clinical visits, and direct-to-patient medications will create opportunities to more efficiently conduct clinical research remotely where it is appropriate,” said Voth.
“Even though it hasn’t been easy, this is an exciting time to see how clinical research is evolving,” added Roposa.
Learn more: Webinar with key learnings for restarting clinical research
While UHN is one example of successful collaboration and innovation in clinical research restart, hospitals across the province are also resuming clinical trials. In addition, sponsors are working together with sites to come towards solutions to get trials up and running again. On August 12th Clinical Trials Ontario will be hosting a roundtable webinar to discuss challenges and solutions to clinical research restart. Register for the webinar here.