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. Rémi Quirion, Chief Scientist of Quebec.
Q. How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Quebec?
Preserve improvements in clinical research after the pandemic.
During the crisis, decisions were made much more quickly at various levels: Ministry of Health, public health, and Health Canada. After the pandemic, we must keep doing the things we have been doing well.
For the COLCORONA study, we managed to set up a relatively complicated clinical trial with ethics committee approval within 48 hours. The biobank is another example that proves that we can work together to decide on protocols in only a few days. Experience has shown us that it is possible to speed up the process without going through a whole series of steps, while still maintaining the impeccable study quality required to ensure rigorous results. New technologies such as artificial intelligence could be used for faster analyses.
“Why does the approval process normally take months? To keep these new, faster approaches in place once the pandemic is over, we will need to understand how we were able to expedite them. We are able to conduct high-quality studies faster, without cutting corners. We need to figure out how.”
There is no question that the pandemic has created countless problems. Fortunately, there have also been positive aspects, such as showing that there are ways to streamline regulatory steps to speed up the approval process. Since time is money, this should be an area of focus when looking at reducing the time it takes to develop drugs.
“A key element of this discussion will be that our elected leaders, ministers, premiers, and public health decision-makers should choose to move in that direction, namely that of streamlining processes.”
Our leaders will have to firmly state “This is what we want to do, and this is what we need to do.” That is the only way to get the bureaucratic machine to agree to it. However, decision-making at the federal level may be a problematic issue. While the provinces will likely be able to make good progress, they probably won’t agree to the Canadian government dictating which choices they can make. The fact that health care is under provincial jurisdiction could complicate the implementation of any changes. It is much easier to implement national guidelines in England, where health policies are federally regulated.
Agreeing to do things differently.
Change is often difficult to implement: many will say that since something hasn’t been done before, it shouldn’t be done now either. The pandemic has made us consider our current methods, look at (and review) our habits, and step out of our comfort zone. Each sector wants to protect its assets, and this territorial composition applies to all levels: within a hospital, a university, a company, the ministry, and the government.
“Now is the time to reconsider our exclusive domains.”
To find ways to streamline processes and integrate change, we should recruit people whose expertise is somewhat different from that of public servants, such as those with knowledge of artificial intelligence or digital technologies. Bureaucrats often resist integrating these technologies, which force them out of their comfort zone. They need to develop a new way of approaching problems and be open to modernizing methods of enforcing rules to minimize delays. To foster transformation, training which is adapted to the post-pandemic reality will be necessary.
“It won’t be easy to change the current methods, and there will be some resistance, but this change is necessary.”
Maintaining the progress made during the pandemic.
During the pandemic, telemedicine has taken center stage and faxes are no longer being used. Once the crisis is over, we should not go back to our old ways; we should look at what we have learned from the situation to find ways to do better in the future.
Technology has become more vital during the crisis. For example, in the case of COLCORONA, CGI set up a huge digital infrastructure so that the study could take place remotely at several sites in Quebec, Canada, and the United States. Several international institutions have also used this type of strategy in major COVID-19 initiatives. Remote trials will benefit everyone, especially developing countries. Although these studies offer many opportunities, we must still ensure that the quality of these trials is maintained.
“Patient partners need to be involved in the process without delay, as change is most likely to occur through them.”
Q. How has the crisis affected patients?
Looking for ways to restart non-COVID care.
Once the pandemic is over, there will be a lot of catching up to do since the current focus is solely on COVID-19. Patients with diabetes or heart problems have been afraid to go see their doctor, surgeries have been delayed, and clinical trials that were underway are experiencing delays. The future side effects of the crisis may be extensive. For example, Dr. Tardif, who usually focuses on cardiovascular disease, has put his work aside to devote himself to COVID-19 on a full-time basis.
“We won’t be able to keep up this pace for very long. We will have to figure out how to get patients back into the health care system.”
Considerable emphasis has been put on COVID-19, but other diseases should not be forgotten. People are waiting too long before going to the hospital. We need to tell the public that it is safe and that they need to seek care. There will be a lot of anxiety, so we will need to put implement additional health measures and explain them well.
When it comes to starting clinical research up again, it won’t be easy. A lot of money will have been lost, clinical trials will have to be extended, and patients may not show up because they fear entering hospital facilities.
The government will help to offset the private sector’s losses.
The enormous financial losses suffered by all clinical research stakeholders are also being felt in all economic sectors, such as the restaurant and tourism industries, in which the situation is even more dire. Over the next few months, governments will be offering support. In the past, companies were the ones who met these needs but now, it will be up to the government and various foundations to do so.
The federal government has announced a massive research financing program, which will temporarily replace money from private industry; a significant portion of it will go towards clinical studies. Quebec’s clinical research facilities will have to submit an application for this financing, which will cover indirect costs. In the short term, this is probably the best solution because the industry will undoubtedly face considerable challenges.
Q. How can we improve the way we conduct clinical research in Quebec?
Start clinical studies early to accelerate innovation.
Research is part of a continuum that leads to the innovation and commercialization of a product, process, patent or discovery. In order to accelerate innovation, clinical research needs to be started early in development and with substantial resources.
While here in Quebec, we don’t have all the means in the world to invest in early clinical research, yet we do have high-quality facilities and expertise; we must make the most of them. In my opinion, this is not what we are doing right now, particularly at the CHUM and the MUHC.
“We have very nice spaces and excellent facilities, but some are sitting empty or not used properly.”
We cannot ask the private sector to fill these facilities; we also need public agencies and academic researchers to become more invested in clinical research. Both sectors must be involved in this effort, but a lot of work still needs to be done. I hope the pandemic has taught us that not only can we do it, but we can also do it much more quickly.
Changing institutional culture regarding clinical research.
Clinical research must be integrated into hospital care. This message must come from the ministry and the government. To lead by example, they need to use places that are successful in blending the two, such as the Jewish General Hospital. Including clinical research as a component of a hospital’s or UHC’s operations is executive management’s responsibility. We will have to decentralize (even if that means backtracking a little) and include the responsibility of overseeing clinical research in local administrators’ mandates.
“Institutional culture will help to bring hospital care and research together, but the message has to come from the governments.”