COVID-19 and clinical trials : point of view of Marc Rivière
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 look for ways to adapt. The following statements detail the point of view of Marc Rivière, Chief Medical Officer, TVM Capital and Chairman of the Board of Directors, CATALIS Québec.
The future of clinical research after COVID-19
Q. How do you think the COVID-19 pandemic will affect current and future clinical research, both internationally and here in Quebec?
Right now, no one can predict how clinical research will change in the aftermath of the pandemic. The future depends on the scale of the pandemic and how long it takes to dissipate. Moreover, it would be a completely different challenge should COVID-19 become cyclical like influenza and return every year.
“Patients must be protected.”
A large proportion of the clinical studies conducted in Quebec relates to oncology and includes medically fragile patients; as a result, it can be risky to expose them to an infectious threat. Discussions on ethics and contamination management to help protect these patients are currently being held.
“This crisis is an opportunity to consider and review administrative and regulatory processes.”
Since the beginning of the pandemic, regulatory agencies, administrative structures, and ethics committees have had to readjust and adapt quickly to deal with the crisis. Protocols involving innovations in the management of patients with this coronavirus are being accepted with impressive speed. We can learn from these extreme circumstances and find ways to streamline and accelerate the overall approval process for clinical trials.
Quebec’s strong position
Since the CATALIS initiative was created, Quebec has gained a competitive advantage that allows it to better connect its research institutions with major pharmaceutical companies. The province must maintain these gains, and we must use the solutions developed throughout the current emergency to improve as a research community. All industry stakeholders must work together to improve processes, reorganize, and be fully prepared to start up again once the storm has passed. Fortunately, CATALIS is a small structure and can adapt more effectively than a more complex bureaucracy.
By accepting this rapid restructuring challenge with the various review committees, Quebec would be able to be operational in a shorter time than the rest of Canada and other countries, which could considerably increase our competitiveness and bring more clinical trials back to the province.
“The clinical research community must use this crisis to challenge and restructure itself.”
The situation is providing the clinical research sector with an exceptional opportunity to review and improve its working practices. Since the majority of clinical trials have been suspended, stakeholders who have not been laid off or reassigned could perform certain tasks, often overlooked during normal operations, to improve processes. Auditors also no longer perform their usual duties; this would be an excellent opportunity to virtually visit research sites to evaluate and help improve their methods. Once the crisis is over, the research teams will need to be rebuilt and trained so they can adjust their practices to the new reality.
Issues related to the COVID-19 crisis
Q. What do you see as the economic, scientific, ethical, and public health issues facing the clinical trials industry during this COVID-19 pandemic?
The primary concern created by the COVID-19 crisis is the industry’s finances.
- Quite a few biotech companies, especially the smaller ones, are at risk of closing due to a lack of capital.
- Depending on the situation, the marketing of several products will be delayed by anywhere from three months to a year.
- Numerous employees laid off during the pandemic will need to find a new job. It is possible that once the crisis is over, many of them (mainly nurses) will relocate elsewhere and not return to their clinical research positions.
“The companies that will survive are those that will be more flexible and responsive in finding solutions.”
The impacts of the pandemic
Q. In your opinion, what will the impacts on patients be, both in the short-term and the medium-term?
It is both unfortunate and evident that those who will suffer most from the crisis in the short-term are the patients with the most serious illnesses. Many will no longer have access to the innovative treatments and personalized care offered by clinical studies. However, the benefits of their participation in studies must be weighed against the risk of exposing them to COVID-19.
In the medium-term, patients with severe illnesses or orphan diseases may not receive treatment in time, yet those with a chronic disease who are not at immediate life-threatening risk will be less affected since they are already receiving appropriate therapies.