Vatche is the President and Founder of Vantage BioTrials, a Canadian CRO specialized in clinical trial management services. He’s contributed his strong drug development knowledge to the pharma and clinical research industry for over 22 years and has gained vast experience handling complicated trials across an array of therapeutic areas. He’s an expert in Clinical Operations, Project Management, Quality Assurance and Clinical Monitoring. He was recently appointed as an Advisor to Global Affairs Canada’s Life Science group, providing advice on how to better position Canada as an effective and competitive place to run clinical studies.
He spoke to IMC about the challenges of conducting clinical trials in the midst of a global pandemic.
IMC: Is Vantage BioTrials Inc. leading any COVID-19 related research?
We are excited to announce that we’ve just started planning a clinical study for a local Canadian biotechnology firm who is repurposing their current novel therapeutic product to fight against COVID-19 and actually change the impact and outcome of the disease. The study is currently in “start-up” phase and we’re anticipating recruiting our first patients in Canada and the U.S. very shortly. More details will be announced soon via newswire. In addition, we have been approached by several other life science firms and academic research institutes to run additional COVID-19 trials.
IMC: How is the COVID-19 pandemic affecting the clinical trial industry in Canada?
As soon as lockdowns were announced in March, we felt the immediate results. Our sites provided us with quick feedback that their trial participants were no longer willing or able to attend regular visits, and all new study initiations were being placed on hold until further notice. For us, this resulted in at least one major international study being postponed indefinitely, and a few others delayed due to a sudden halt in patient enrollment.
We’ve immediately noticed the following challenges for patients participating in a trial; social distancing requirements, site access restrictions, travel limitations, interruptions to the supply of investigational products, and an increased strain on hospital resources. These challenges have led to difficulties in meeting trial-specified procedures, including following mandatory visits, and access to laboratory or diagnostic testing.
It’s also been particularly difficult for oncology research participants. For many cancer patients, research represents hope, yet most understand that they are particularly vulnerable to COVID-19, are at increased risk of severe outcomes if they become infected. Oncology research is experiencing a hiatus at this time; trial participants have to be protected as much as possible, and this sometimes entails not enrolling them during the pandemic. We have therefore noticed a decrease in the number of new requests for non-COVID studies spanning all therapeutic areas. Whenever we do receive a new request for managing a non-COVID study, we perform a thorough feasibility and safety analysis with information on-hand, which then determines whether or not we should move forward in initiating the study during the pandemic.
IMC: How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Canada in the long term?
I believe the most positive result of this global pandemic and its effect on clinical trials is that technologies and services like virtual trials, remote monitoring, and home nursing/healthcare solutions are no longer just discussions. Instead, we are accelerating their use for almost every clinical trial that wants to continue providing support and safety to its patients. However, a big question remains, and the answer is highly dependent on the course of this novel virus in the next year or so: how long will it be before we find effective treatments/vaccines, and how can we best evaluate what the impact to clinical trials will be if none are found? Regardless of the answer, it’s obvious that a “new normal” is being established for the future of clinical research.
As the situation continues to develop and expand across all regions, we need to keep a close eye on regional number of active cases of the coronavirus spread in the country/state/province. The more active cases in a given region, the bigger the pressure on its healthcare system. This will have a direct negative effect on clinical trial uptake in hospitals and private clinics. We also need to remember that there’s a psychological effect and consequence behind an increased number of cases (or consequent “waves” of infection), as this makes people more scared to participate in any research which involves potential visits to healthcare facilities, especially for higher-risk patients with underlying conditions (e.g. cancer patients, those with auto-immune diseases, etc). Remote patient or at-home nursing visits are part of the future solution. We currently have about 50% of drugs that are biologics that require monitored infusions. I believe that home healthcare is a sector that will see an uptake, and home infusions are going to be an important part of that. Whether it’s measuring a patient’s vitals, drawing blood, or collecting data, it will need to be performed all remotely (which also presents interesting opportunities for the wearable device sector). Not to mention that we also have to figure out how to reliably ship clinical trial materials directly to patients and confirm that they received it.
We also need to contend with regional “stay at home” measures as consequent waves of new infections occur. The stricter the mandated quarantine, the fewer opportunities there are for conducting a clinical trial unless it is fully virtual.
In either case, we have no doubt of the importance and necessity for clinical trials to advance novel therapies, and they must keep moving forward. It’s up to us as an industry to innovate, think outside the box, and adopt or implement novel solutions to this dynamic problem. After all, history has only shown us that major advancements and steps in innovation occur during crises like the one we’re currently facing. I’m confident that our life science partners, represented by the amazing members of Innovative Medicines Canada, will continue to step up to the challenge and lead the way!