COVID-19 and clinical trials : point of view of Julie Autmizguine
In light of the exceptional situation surrounding COVID-19, CATALIS interviewed clinical research leaders in Quebec to find out their perspectives on the crisis and to look for ways to adapt. The following statements detail the point of view of Dr. Julie Autmizguine, Assistant Director of Clinical Research, Sainte-Justine UHC Research Center, Pediatric Infectious Disease Physician, Sainte-Justine UHC, and Clinical Associate Professor, Université de Montréal.
Q. How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Quebec?
The pandemic’s impact on clinical research is significant due to the decrease or postponement of many research activities. The crisis is causing heavy losses of institutional revenues and personnel since only projects deemed essential remain ongoing.
The current context is serving to accelerate the use and development of technologies that allow home visits. This methodology has been considered for several years, and the pandemic is forcing us to use it to mitigate the risk to patients.
The crisis limits the scope of the studies’ secondary endpoints.
Remote monitoring requires more pragmatic protocols with fewer secondary endpoints to minimize the number of samples, as the crisis has limited the quantity of swabs and protective equipment available. When considering ways to use less equipment and reduce the number of visits, more extensive analyses, such as viral load clearance analysis, are difficult to conduct. This limits more ambitious projects such as the biobank. More comprehensive studies are needed to understand the disease better and consequently find therapeutic solutions.
“Once the crisis is over, remote monitoring could continue, with the hope that the number of samples would no longer be limited so that we could explore the issues more deeply than the crisis currently allows us to.”
Staff shortages may slow the resumption of activities.
To minimize the risk of infection, the plan to resume clinical research, like the one to restart outpatient activities, will also need to be assessed. Staff shortages are currently an issue when it comes to conducting studies. As a result, schedules may need to be redefined, condensed or optimized. Regulatory agencies have suggested making adjustments to protocols to safeguard participants’ safety.
If the crisis were to last for an extended period, a space that could reduce the risk of infection by being isolated from clinical care areas is a solution worth considering. Two issues of concern for any such relocation are sufficient staffing and available space.
The crisis has led to many job losses.
A major issue created by the crisis is the significant loss of revenue due to the suspension of trials and the lack of new contracts with the industry. The number of jobs lost is substantial. Furthermore, students and research employees associated with public institutions are not eligible for the current compensation measures available.
It is not known whether laid-off personnel will agree to return and accept this type of job insecurity. Some of the employees may simply not return. Finding and keeping staff was already an issue before the pandemic. This difficulty is likely to be amplified once the crisis is over.
How has the crisis affected patients?
Some patients are currently refusing to come in for visits for fear of contamination. This decrease in follow-up visits creates a risk to participants’ safety and the studies’ integrity.
Studies deemed non-essential, such as those on vaccination, natural products, preventive methods, and diagnostic tests, have been suspended. The research projects provided benefits to patients, but they no longer have access to them. These benefits, however minor, have been taken away from patients. Only trials for treatments of last resort were allowed to continue.
How can we improve the way we conduct clinical research in Quebec?
Sainte-Justine is currently restructuring its clinical research to strengthen medico-administrative management, in which unprecedented investments have been made. Better coordination between clinical research units and research administrators is being implemented, including pairing an operations manager with an experienced clinical researcher to provide support to the various units. We hope that a follow-up of the studies in all units will be digitalized to monitor the trials’ progress and provide a better overview of their status. This sizeable investment will be beneficial and allow us to identify how our processes can be improved. The hemato-oncology department was the first to be standardized, and the effects are very positive.
“Standardizing methods throughout the research center will help to improve institutional quality and enhance contact with pharmaceutical companies, especially during audits.”