Vatche Bartekian, President, Vantage BioTrials Inc.

COVID-19 and clinical trials : point of view of Vatche Bartekian

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 Vatche Bartekian, President of Vantage BioTrials Inc.

The future of clinical research after COVID-19

Q. How do you think the crisis will affect Quebec’s clinical trials industry?

Unfortunately, this pandemic had an almost immediate impact on the pharmaceutical industry,
particularly on clinical trials, just as it did in other sectors. The many restrictions limiting physical
interactions between people brought their share of challenges, and a large number of projects were
slowed down, postponed or even cancelled. We have noted four troubling issues caused by the crisis:

  • Several obstacles are preventing patients from attending their medical appointments
  • Clinical fellows are no longer allowed to visit research sites
  • Staff shortages are delaying the recruitment of patients and the launch of clinical trials
  • The cancellation of major conferences and meetings reduces access to education and the
    opportunity for new collaborations

While considering the current situation, we had to react quickly and suggest solutions to facilitate the
continuation of clinical trials. Despite the ongoing confinement, technology lets us communicate
effectively; we must make full use of it to limit the damage caused by COVID-19.

“In-person interactions and meetings must be replaced by secure virtual initiatives.”

Companies must adapt and promote virtual meetings. Our pharmaceutical clients have taken extra
precautions to ensure the secure transmission of key clinical data. Although these initiatives require
more organization, they are beneficial and can only strengthen relationships between the various

“We must identify ways to make it easier for patients to travel to the research sites.”

One of our recommendations is that sites implement a private transportation system to facilitate
patient travel and encourage in-home health services (e.g., infusion drug therapy).

​ To make it easier to follow up with patients after their doses have been administered, we recommend
that sites and sponsors use remote monitoring or third parties to expedite the process by using tools
such as telemedicine.

Ethics committees are very receptive to changes to current plans, as they understand that these
modifications are necessary to ensure that patients have access to the care and clinical options that
innovative drugs provide. Changes must be carefully considered in protocol amendments so that they
accurately reflect the new procedure(s).

“Staff shortages must be offset by prioritizing central ethics committees.”

Some local ethics committees are more likely to cause delays that could sometimes be avoided by
prioritizing central ethics committees and by discussing and documenting this possibility with the site in
question in advance. With the “Nagano” computer system, Quebec is fortunate to have a facilitated
system for the administrative management of multicenter ethics reviews.

“Let’s be creative in organizing virtual events that bring people together.”

Several groups in our industry are considering organizing simulated virtual events in the near future so
that we can continue to move forward and share our ideas. As organizers of the “Canada Talks Pharma”
conference, we are currently in the process of setting up several online webinar-style
micro-conferences that will still provide opportunities for interaction between participants.

“The collaboration of all Quebec clinical research stakeholders will help us get through the crisis.”

Thanks to the guidelines developed by our regulatory agencies and with a little common sense, we
should be able to work closely with each other to get through this crisis together and be stronger in the
end. Along with other CATALIS initiatives, those of us in Quebec are already in a better position to
access clinical sites and activate them more quickly to launch projects.

For more information on the new guidelines on conducting clinical trials during the pandemic, consult
the guides published by the FDA and Health Canada:

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors