COVID-19 and clinical trials : point of view of Jean-Claude Tardif
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. Jean-Claude Tardif, Research Director, Montreal Heart Institute and COLCORONA clinical trial investigator.
Q. How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Quebec?
The impact of COVID-19 on clinical research was immediate: the COLCORONA study is a good example. Confinement has meant that measures had to be taken so that patients aren’t required to leave their homes: recruitment by phone, electronic consent, home delivery of medications, and telephone follow-ups.
“The crisis has forced us to find innovative solutions to conducting studies quickly.”
The crisis is an opportunity to learn a great deal about remote clinical research. These methods could certainly be implemented in the future. In fact, once the pandemic is over, we will be announcing that a new study will be conducted using this type of approach, i.e. without requiring that patients go to clinics or hospitals.
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 purpose of clinical trials is to demonstrate the effects of new treatments and methods for patients. These studies are the key to finding solutions to the crisis. The unexpected situation brought about by COVID-19 forced us to be creative in conducting research without patients having to travel. COLCORONA is a world first that was established in six days – a record time – and involves technological and telephone tools with much lower operating costs.
“We must not repeat past mistakes.”
Over the last ten years, the pharmaceutical industry has reduced investments in, and moved away from, microbiology and virology studies. In retrospect, this strategy was a mistake; infections remain a threat to humanity and need to be investigated more thoroughly. While allocating more resources to COVID-19 research right now is a natural response, it is essential to continue to invest in infectiology in the future. However, pathologies such as chronic diseases (including cardiovascular disease, cancer, and dementia) must also be studied as they are major factors of morbidity and mortality.
Q. In your opinion, what are the impacts on patients?
Clinical research is what advances patient care practices and improves all aspects of medicine, such as diagnostics, treatment algorithms, therapies, etc. Double-blind, randomized controlled studies with good statistical power are the basis of all new knowledge used to change medical practice significantly. During the advent of HIV and the SARS outbreak, small open (not double-blinded) studies were conducted, but their conclusions were not robust. We must learn from the mistakes of the past. In the case of COVID-19, only a robust clinical trial will bring adequate answers for the patient, the health care system, and the government.
“The patient is at the core of clinical research.”
The pandemic has reminded us of the importance of clinical research in medicine and, above all, highlights that patients are at the core of the solution. If patients don’t agree to participate in studies, there will be no answers, no treatments, and no vaccines in the short term.