Monique Lacroix, Country Head, Development Operations (Clinical Research), Novartis Pharmaceuticals Canada Inc.

COVID-19 and clinical trials : point of view of Monique Lacroix

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 Monique Lacroix, Country Head, Development Operations (Clinical Research), Novartis Pharmaceutical Canada Inc.

Q. How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Quebec? 

It is necessary to preserve the integrity of the studies and to validate that protocols are being followed through continued oversight. While this monitoring helps to generate robust and reliable data, it is especially important to protectpatients participating in clinical trials by ensuring that they receive their medication and that proper follow-ups are done. In this regard, the COVID-19 crisis has created some challenges in making sure that study patients are adequately treated and followed. Quick adjustments had to be made in collaboration with all stakeholders involved.

“The crisis has forced us to revise our approaches to allow as many patients as possible to continue their treatment and participation in the studies.”

Many processes were quickly reassessed and restructured to allow as many patients as possible to continue participating in the clinical trials, such as implementing remote follow-up visits and home delivery of medication.

Decentralizing clinical research for patient follow-ups

Decentralizing clinical research has been an active topic of discussion for some time; it would offer several benefits to the patient, such as less travelling. However, current studies have not been designed to incorporate such features, as many protocols require physical examinations. In the future, experimental designs will need to be developed differently by integrating more digital tools; some examples are electronic sensor measurements, virtual visits, telemedicine, and online consent management.

“Decentralization will lead to clinical research that is more focused on the patient, their reality, and their needs.”

The pandemic is an opportunity to implement these new approaches more rapidly and to learn about decentralization’s best practices, as this transformation is likely to be beneficial in the post-crisis era.

Centralization of the administrative processes for clinical research

By contrast, the centralization and standardization of administrative processes would serve to accelerate decision-making and better manage a high volume of studies. To continue clinical trials during the pandemic, ethics committees had to act quickly in light of the urgency of the situation. Assessing and maintaining this approach may prove to be a positive result of the COVID-crisis.

Q. What are the economic, scientific, ethical, and public health issues facing the clinical trials industry during this COVID-19 pandemic?

Researchers and regulatory agencies have mobilised and come together quickly to find an effective treatment or vaccine against the coronavirus: more than 300 clinical trials have been started. Research in infectious diseases will undoubtedly continue after the crisis, as future pandemics could occur. Although significant financial resources are currently being put towards COVID-19, pharmaceutical companies will continue to invest and develop their pipeline in the other therapeutic areas.

Q. What are the impacts on patients? 

 “An interesting aspect of the pandemic is that it has increased the general public’s understanding of the importance of clinical research.”

The publicity the crisis has created for the sector has made people aware that finding new treatments takes time.  People will understand that solid evidence and randomized controlled trials are essential to ensure the effectiveness and safety of drugs.  Because of current confinement guidelines, the number of patients in studies will not increase in the short term. However, in the long term, this awareness may lead to more people participating in clinical trials.

Q. How can clinical research in Quebec be improved?

Starting projects faster is the key to being competitive internationally. I think CATALIS can support research centres during the crisis by providing standardization tools and the means to implement them more quickly. It is by centralizing decisions that stakeholders will be able to speed up the process.

We must also maximize the use of technological advances. Electronic medical records can be used to efficiently monitor and perform follow-ups of studies remotely; however, this practice is not very accessible in Quebec or elsewhere in Canada. The pandemic could prompt some hospitals to revise methods and find solutions to broaden access to electronic records securely.