Jacques Hendlisz, Executive President, CATALIS Québec

Message from the President

I am delighted to be joining CATALIS Québec in order to contribute to the development of clinical research in Quebec and to foster solidarity between all industry stakeholders to improve the care of patients suffering from currently incurable diseases.

As the new President, I would like to take this opportunity to report on the exceptional and intense situation we are currently experiencing. As soon my mandate began, I made it a point to question a dozen industry leaders to gain a better understanding of the pandemic’s effects on clinical research and provide me with a realistic assessment of the situation. The impact on the sector is undeniable (loss of financing, workforce breakdown, delays in non-COVID trials), as is the effect on patients (limited access to care, fear of going into hospitals, and delays in bringing new innovative drugs to market). The COVID-19 crisis will significantly change the world of clinical research; the transformation has already started.

As soon as the crisis began, the network quickly took remote monitoring measures to protect patients while allowing them to remain in the studies and continue receiving their experimental treatments. Leaders agree that this decentralized approach will continue after the pandemic, but that protocols will need to be adapted and validated to maintain data integrity and patient safety.

In reaction to the urgency, ethics committees have also accelerated the approval of new protocols and amendments to studies in a most impressive fashion. This response to the crisis reflects the tremendous collaboration between all parties, the simplification of processes, and the reorganization of activities. This strategy must be maintained and strengthened so that processes can continue to be expedited even once the crisis is over.

While it is still difficult to accurately predict where all these changes will lead, one thing is certain: we will have to adapt and adjust to the changes resulting from the crisis to reaffirm our ability to conduct clinical studies in Quebec. The upcoming implementation of new regulations aimed at reducing the price of patented drugs, conducting clinical trials outside of hospital settings, and the possibility of fewer studies being financed by pharmaceutical companies are reforms that may impact the clinical research environment.

Talking with industry leaders has helped me understand that no matter which solutions are chosen, the lessons we have learned shouldn’t be ignored: we must ensure that these measures are beneficial to patients. Moreover, I consider that the province must position clinical research and view it as a continuation of patient care. For Quebec to remain competitive in attracting clinical trials, we must also change how studies sponsored by pharmaceutical companies are viewed, as they finance a large portion of clinical research and contribute to the survival of research centers. For example, in 2016, pharmaceutical clinical trials generated close to Can$760 million in costs avoided by the Quebec health care system (e.g., drug costs, equipment, patient procedures, administrative costs, and indirect costs).

We need to learn from the crisis to find ways to improve our practices and refine our ability to attract more clinical trials so that more patients can benefit from cutting-edge treatments.