COVID-19 and clinical trials : point of view of Angela Genge
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 ofDr. Angela Genge, Neurologist and Director, Clinical Research Unit, Montreal Neurological Institute-Hospital.
Q. How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Quebec?
At the Neuro, we continue to conduct clinical trials during the crisis continuously. The Neuro is a designated non-COVID hospital in order to protect our specialized patient population. A second facility outside the hospital has been identified as able to welcome patients in clinical trials and arrangements have been made with the ethics committee to allow the transfer if necessary. However the crisis has provided an opportunity to look for a better way to conduct clinical trials in order to attract more clinical trials for Quebecers. The fact that pharmaceutical companies sponsor the majority of the Institute’s studies is providing insight into how the future will be different from the present.
“The crisis is an opportunity to attract pharmaceutical companies so that we can continue studies here that have been suspended elsewhere in the world because of COVID-19.”
Since many American and European cities have had to stop their clinical trials temporarily, pharmaceutical companies are now facing long, disastrous delays and must find a solution to continue those studies that do not pertain to COVID-19. Quebec’s health care system is managing the crisis well and the situation is under control, which allows us to attract these suspended studies to obtain the results necessary to achieve the primary objectives. To be efficient, effective and able to continue high quality clinical trial execution is our mandate. The pandemic is an opportunity to show that Quebec is a strong and dynamic place for drug development.
Improving patient recruitment methods
There has been diminished recruitment because of the crisis, as physicians no longer see patients and no longer refer them to studies. For research to continue, it is crucial to find new ways to attract patients. Since people are spending a lot of time online during this confinement period, social media could be an effective way to reach them. Creating a large registry of patients and their illnesses will make it easier to identify those who are eligible for clinical trials. We have three types of electronic medical records (RAMQ, DSQ and Omnimed/Oasis) that would be ideal resources to use to develop these platforms.
“To foster recruitment, direct communication with patients should be established, as initiatives are limited by a lack of awareness of the ethical considerations involved.”
Ethics committees have a protective attitude to ensure that patients are not recruited under duress. This protection, however, prevents them from getting the information they may need more directly. We need to inform them better and make studies more accessible. The current system is inadequate, and people are struggling to find trials even though these studies are being conducted in their condition in Quebec and could be useful to them. We absolutely must review our approach with ethics committees so we can recruit patients more directly into studies that could help them and improve their health and quality of life.
Q. How can clinical research in Quebec be improved?
At the Neuro, Dr. Genge is the head of the Clinical Research Unit. She helps researchers build their profile to attract companies to conduct studies relevant to their patient population. The funding of clinical trials by the pharmaceutical industry allows the center to be self-financing and to have its own facilities.
“University hospitals need to recognize the value of studies funded by pharmaceuticals.”
The most productive centers are those in which administrators consider financial sustainability and participate in patient recruitment. Facilities with their own premises that they can renovate and that are close to the clinic are the most efficient. Research sites should be more proactive in generating revenue and not requiring financial support from hospitals.
Providing support to scientists will foster research. One beneficial measure is to offer incentives to conduct clinical studies and recruit more patients while giving them freedom and control over their projects. Conversely, asking them to pay to use the clinical research units’ facilities discourages them. Collaboration between research and clinical care leads to success and must be developed further in hospitals.
The delays in signing contracts are often a significant obstacle to the development of clinical studies. One way to speed things up is to have direct and courteous contact with the contract office to minimize wasted time. The time it takes to obtain contract approval is critical to being able to participate in large-scale studies.