By Jim Rudman, CEO, Ashton Tweed
When Ed Seguine, CEO of Clinical Ink, joined the company in 2010, he saw that there was a huge opportunity for improvement in the clinical trial space. In an interview with Ashton Tweed, he says, “At the time, I’d been in the clinical trial technology space for about 10 years, and during that period, I looked at the way that clinical trials were being executed and concluded that we weren’t really doing anything different. Although the industry was starting to adopt new technologies, the process itself was complex, cumbersome, and manual. Sadly, the clinical trial business model still primarily revolves around transcribing data from system to system days or weeks after the patient leaves the office.” Of the digital changes that Seguine hopes to make in clinical trial execution, many revolve around the idea of going virtual.
The global pandemic has only highlighted the need for this drastic change. Although the life sciences industry plays a direct role in fighting the virus, organizations worldwide have suffered major disruptions. “Disruption of clinical trials has been the most costly, with patient recruitment slowing at many academic centers in the United States and much of Europe. Clinical outsourcing firm Icon reported on April 22 that nearly two-thirds of its global sites had been affected; a provisional study found that 1,099 trials were stopped for COVID-19–related reasons between December 2019 and May 2020[…] It’s possible that digital technologies to recruit and monitor trial patients remotely can help, but so far radical shifts in trial design to accommodate COVID-19 disruption have not happened,” (Nature). Unfortunately, as witnessed in the cautious rise of digital health in recent years, change is notoriously slow in our industry due to its highly regulated nature.
Over the past few months, we’ve spoken with many clients who have had to rethink their approach to trial patient interactions by utilizing technology and going virtual. We’ve also connected with virtual clinical trial companies who have amped up their services to support the influx of business during the coronavirus quarantine. Although many new trials are being delayed, critical trials are continuing in new and innovative ways. For example, Vertex Pharmaceuticals says it’s doing its best to continue with its pipeline strategy by developing a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures,” (Endpoints News). As companies embrace these new strategies, the benefits of remote patient monitoring in clinical trials are becoming clearer.
Benefits of Virtual Clinical Trials
Patient attraction, adherence, and retention are all common struggles when running clinical trials, and never before have companies been tested so brutally to overcome these obstacles as they are now by the global pandemic. However, not all industry responses have been slow – the rapid embrace of telehealth during the quarantine not only proves that change is welcome, but many patients hope the change is here to stay. “Video visits have become very commonplace and accepted within our system. We are finding patients absolutely love video visits,” says Kerry Palakanis, executive director, Connect Care operations at Salt Lake City-based Intermountain Healthcare (FierceHealthcare).
Patients need medicines regardless of what’s happening in the world around them, and our industry will have to pave new ways forward to safely complete clinical trials despite obstacles like Covid-19. As life science leaders look to make this shift, they will need to make sure they have the right talent in place – talent that has hands-on experience with clinical trials but also understands the digital component that remote patient monitoring entails. In many of our case studies, we’ve seen that interim talent is a successful hiring strategy to get your company through specific phases of your clinical timeline, and it will likely prove to be a valuable tactic when making virtual adaptations to your clinical operations.
Although our industry has been steadily expanding into the field of digital health, pharmaceutical and biotech companies are just now facing the reality of how important this capability can be – it may mean the difference of shutting down or staying on schedule during challenging times. It all comes back to the patients, who are relying on us to provide the drugs they need, and our industry has a responsibility to deliver them against all odds. What have your experiences been during the quarantine? We are curious to see how other life sciences companies are managing their clinical trial complications. Let us know in the comments below!
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