Clinical Researcher—September 2021 (Volume 35, Issue 7)
TRIALS & TECHNOLOGY
Gadi Saarony, MBA/MIM
March 18, 2020 marked the day the U.S. Food and Drug Administration (FDA) brought clinical research to a near stop, sending the life science industry into an existential crisis. Almost immediately, clinical trial organizers found themselves in a fight for survival, contending with pandemic-related challenges in data collection, availability of site staff, scarcity of personal protective equipment, and, perhaps more importantly, dwindling participation and engagement of patients in clinical trial processes.
Despite these challenges, clinical trials and their practitioners have since persevered. They are not only experiencing a fundamental transformation, but an all-out renaissance.
In many ways, the pandemic has forced business leaders to completely rethink the ways in which they conduct clinical trials on a global scale—bridging legacy gaps that have long existed within the industry. Now, as a result of game-changing innovations in telemedicine, decentralized monitoring, and wearables, clinical trials are experiencing a resurgence in both engagement and interest—with 68% of U.S. adults with at least one medical condition saying they are now more likely to consider participating in a trial than they were before the pandemic.
With the above in mind, here are a few key insights about how the COVID-19 has catalyzed a digital renaissance within the clinical trial space.
Ask anyone in clinical trials, and they’re likely to say the same thing: trust is integral to the process. Because any data you collect are ultimately included as part of your regulatory submission, healthcare companies want to ensure—with the highest degree of certainty—that their therapeutics are manufactured, administered, and monitored correctly, every step of the way. However, due to safety concerns stemming from the COVID-19 pandemic, many in the industry were forced to put their trust in a digital world, albeit while asking how they can uphold confidence in processes they can’t be present to oversee.
In gaining this confidence, many life sciences company leaders needed to lean on existing technology in order to seamlessly adapt clinical trials processes to the new normal. Thankfully, equipped with the latest in telehealth, eConsent, and wearable technologies, clinical trial directors quickly realized that they could track and monitor patients in real time—using trusted devices—all from the comfort of their own homes. Not only did this make clinical trials easier, it made them smarter, connecting site training and patient engagement tools with existing regulatory compliance solutions and clinical site technologies that, consequently, improved data accuracy and quality.
With an estimated 85% of all Americans currently owning a smart phone, the ability to meet with, and record, trial participants remotely has since created a much smarter and more flexible approach to clinical trials, consequently giving healthcare companies access to a fuller picture of therapeutic efficacy.
While it’s difficult to label anything having to do with COVID-19 as a “positive,” one of the few blessings of the pandemic has been a heightened interest in clinical trials. Historically, clinical trials have taken anywhere from two to six years to complete. Now, with the COVID-19 vaccine rollout showcasing the incredible speed and efficacy of clinical trials at scale, life sciences companies have since realized that they can leverage decentralized technology to encourage optimal trial candidates to participate. In doing so, not only can they make data collection processes faster, they can also speed up data collection, analysis, and submission processes.
Consider the implications for future studies. Equipped with the very breakthroughs that “kept the lights on” during an otherwise dark period in research and development, scientists have since been able to speed up the process by which data are recorded, analyzed, and reported—leveraging past data to make informed decisions on everything from protocol optimization to site selection to patient engagement. In fact, some experts estimate that machine learning and other artificial intelligence technologies can potentially speed up clinical trial processes by 300%.
Sites that can leverage clinical research solutions are well prepared to bring this level of scale and access to the industry. By combining new cutting-edge tools with heightened interest in the process, trial organizers may finally be able to streamline costly and time-intensive processes that have long inhibited scientific advancement—all while providing trial access from the comfort of a patient’s own home.
Of course, it’s worth noting that the COVID-19 pandemic has played an incredibly important role in ensuring the safety of the clinical trials process as well. Imagine, for a moment, that you’re a scientist studying a promising therapeutic at the beginning of the COVID-19 pandemic. You’re in survival mode, working tirelessly to keep your trial alive while participants are scared. Yes, you’re worried about agility and efficiency, but safety is really of the utmost importance—ensuring that the potentially life-saving treatments you’re creating are actually helping, and not hurting, those who need them.
Thankfully, clinical trials directors have since been able to breathe a sigh of relief. Not only have remote technologies proven effective at ensuring trial safety, they have also been shown to be tremendously helpful at spotting red flags, monitoring side effects, and triaging symptoms before they become severe. Simply with a touch of a button, a patient’s smart phone has now become an outlet to ask questions and/or report problems, allowing scientists to focus on patient centricity, education, and enablement in a more direct and more transparent way.
Whereas before patients would have to wait for in-person visits to receive assistance, now they can reach out at all hours of the day—a game-changing advancement that has forever revolutionized the patient-provider relationship and allowed for around-the-clock access to valuable information.
As the threat of the COVID-19 pandemic recedes and we are beginning to return to normal, there will be hundreds of stories published about how industries have risen to the occasion in the face of adversity. None, however, will be as consequential as the tales told about clinical trials. At a time when many industries were paralyzed by indecision, the life science industry remained unwavering in its commitment to improving global health while leveraging pioneering digital advancements to keep its most promising assets alive. The result? A digital revitalization of legacy processes that proves that the best in clinical trials is surely yet to come.
Gadi Saarony, MBA/MIM, is Chief Executive Officer for Advarra and a former Executive Vice President for Parexel.