As COVID-19’s first wave crested and broke, the need for clinical studies became more acute. Studies related to treating the disease – not to mention the all-hands-on-deck drive toward a vaccine – shifted into high gear.
Prior to early 2020, life science clinical trial development teams relied heavily on in-person investigator meetings and patient visits, working through scheduling challenges and years-long development cycles to reach commercialization endpoints for new therapies. With about 80% of non-COVID trials stopped or interrupted by the pandemic, and many resources shifted to coronavirus-related studies, these fragile timelines were at risk of getting further off-track.
The shift to virtual trial tactics
With in-person interactions drastically restricted, patient availability and communication related to clinical trials – and the associated data – began to suffer. Teams looked for ways to rethink site initiation visits, monitoring visits, regulatory inspections, audits, and more, all while physicians and the life science industry at large could focus on little other than COVID-19 response.
The primary consideration for most industries navigating the pandemic included investing in new technology – in fact, nearly 25% of CEOs say their businesses will be more digital following COVID-19 – but clinical teams needed more than video conferencing platforms and instant messaging to ensure safe and successful studies. Instead, they needed to completely reimagine ways of working to enable viable, virtual engagement with HCPs, investigators, patients, and other trial stakeholders at every phase of drug and device development.
The acceleration of decentralized clinical trials
The pandemic didn’t create decentralized clinical trials (DCTs). Instead, it erased – nearly overnight – years of hesitation to employ a more virtual approach to patient monitoring and other trial activities. The ubiquity of smartphones and tablets, more reliable internet, and availability of wearable sensors and other devices contributed to an environment where virtual clinical trials were not only possible, but more efficient and more data-friendly than traditional methods. With patient monitoring and data collection going virtual, it only made sense to move toward a more virtual approach to elements like study design, clinical trial feasibility assessment or clinical trial site selection, data review, and other tasks that might typically have face-to-face elements and require travel.
Lessons learned for the future
In some cases buoyed by tech-savvy peers and in others simply taking a leap of faith, clinical teams adopted – and then championed – virtual engagement. They learned to rethink meeting structure, evolving from large-format live meetings to asynchronous sessions with on-demand webcast elements. The change not only allowed work to continue but also accommodated the human element: clinicians on the front lines or juggling work and family demands from home weren’t forced to carve out yet another hour of time multitasking while on camera, a welcome change for healthcare workers stretched to the limit. And by doing more virtual work and sitting through fewer virtual meetings, clinical teams began to see that virtual engagement wasn’t just a crisis-induced stopgap.
A new model for clinical teams
With coronavirus vaccines available, many people plan to resume pre-COVID habits like travel and face time (as opposed to no travel and FaceTime). However, as variants continue to emerge and governments and businesses remain cautious, clinical teams will continue to rely on virtual tools to not only keep trials running, but find ways to improve the execution and results of important studies.
What do clinical teams need to continue building value and accelerating innovation?
Open-mindedness. Without the willingness and flexibility to change your team’s approach to collaboration, making the shift to more virtual interaction is a no-go. Help your team understand the benefits of being more agile and less beholden to factors out of their control, like travel and other people’s schedules.
Internal change management. Any new process or new tech needs buy-in, and communicating the value of a new approach is critical. If you have to build a case for pivoting to more virtual engagement, make sure your justification aligns with the team and corporate goals.
A learning mindset. If there’s one thing teams can take from the COVID-19 crisis, it’s that change can have benefits. Once circumstances begin to stabilize and there are more options around how we meet and collaborate, we can choose to revert to old ways or continue to explore what’s possible with a fresh approach.
Patient focus. Home-based or virtual clinical trials are good for patients and tend to experience more successful enrollment and fewer dropouts. By prioritizing what patients want and need while participating in a clinical trial, teams will be positioned for success.
The last two years showed clinical teams the way to not only sustain but accelerate important work and innovation, regardless of the ability to do so in person. This is reason to be optimistic about successfully meeting challenges ahead, and about the potential to realize improvements in patient outcomes and human health.
