President of Vantage BioTrials Interviewed by CATALIS on the State of Clinical Trials Industry in Quebec During the COVID-19 Crisis
Amid these unprecedented times during the COVID-19 pandemic, Vantage BioTrials’ President, Vatche Bartekian, was recently interviewed by CATALIS in order to gauge his understanding of the crisis and, with his valuable insights, explain how Vantage BioTrials is adapting to overcome some of the challenges.
The future of clinical research after COVID-19
How will this crisis affect the clinical trial industry in Quebec?
Just like in other industries, this pandemic, unfortunately, had an immediate impact on the pharmaceutical industry and notably clinical trials. The multiple restrictions limiting physical interactions between people entails many challenges and a multitude of projects that have been curtailed, postponed or even canceled. In the past weeks, we have observed four major problems linked to the current crisis:
- Many obstacles stop patients from going to their medical appointments.
- Clinical monitors are not allowed to be physically present on-site.
- There is a lack of available/working site personnel, which results in the delay in site activations/initiations and recruitment of patients during clinical trials.
- Cancellation of peer-to-peer conferences and meetings greatly reduces the access to continuing education and the possibility of new collaborations.
By reflecting on the situation we’re currently in, we had to react quickly and brainstorm different solutions in order to minimize disruptions to operations. Despite confinement, technology permits us to communicate efficiently. These technological tools can be utilized in order to limit the negative impacts caused by COVID-19.
“Meetings and physical encounters between stakeholders should be replaced with virtual secure platforms”
Companies have to adapt and encourage virtual meetings. Our pharmaceutical clients took time to put in place extra precautions and security measures in order to guarantee a safe method of communication of key data. Even if these initiatives take more planning and organization, they are beneficial and can reinforce relationships between parties.
“We should identify methods to facilitate a system for transporting patients”
We recommend for sites to implement a private transportation service in order to facilitate transportation for patients and to favor homecare healthcare services (e.g. drug administration under perfusion).
In order to facilitate follow-ups with patients following drug administrations, it is our recommendation to sites and sponsors to implement follow up from home or to manage with tiers in order to accelerate activities by using surveillance tools at a distance such as telemedicine.
Ethics committees are receptive to these types of modifications as they understand that this is necessary in order to guarantee access to healthcare services and clinical options concerning innovative therapies. The changes must be done carefully and the protocol amended accordingly in order to reflect the new procedure.
“The lack of available/working site staff has to be countered by prioritizing central ethics committee reviews”
Under-staffing also causes delays in review and approval by institutional local ethics committees. In order to avoid delays to new or ongoing studies, some local ethics committees might be open to allow a switch to central ethics committee reviews, and this should obviously be discussed and documented beforehand with the site in question. In Quebec, we already have a process to facilitate the administrative management of multi-centric ethics committee reviews using the “Nagano” system.
“Let’s be imaginative in order to organize collective virtual events”
As many in-person conferences are now canceled or indefinitely postponed, numerous groups in our industry are planning to organize virtual events in order for us to keep moving forward and share our ideas. As the organizer of the annual “Canada Talks Pharma” conference, we are currently in the process of putting together smaller online events in the style of “webinars”, while making sure to keep our participants highly engaged.
“The collaboration of all Quebec stakeholders in clinical research will allow us to overcome this crisis”
With the help and guidance from regulatory agencies and by using some common sense, we should be able to closely collaborate in order to get through this crisis together and come out of it stronger. With other initiatives being realized by CATALIS, we are already in a better position in Quebec to access clinical sites in order to activate them quicker so that projects start more rapidly.
Vantage BioTrials, Inc. is a leading Canadian Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to international biopharmaceutical, biotechnology, generic pharma, and medical device companies within North America and Europe. We are experts in implementing Risk-Based Management through the use of Quality by Design (QbD) methodologies, which helps accelerate the conduct of a study and reduces overall risk.