Impact of COVID-19 pandemic
During the development of the COVID-19 pandemic, thousands of organizations reported disruptions in the conduct of clinical trials, with more than 42% of sites in the U.S. reporting that their trials had stopped altogether. As a result, there has been a re-examination of protocol designs in favor of virtual clinical trials that prioritize participant safety and maintain study integrity while adhering to social distance guidelines.
Virtual transformation, which once seemed like a radical idea, is now on the fast track. Sure, it’s a huge challenge for sponsors, but for patients, it’s an incredibly easy and cost-effective transition. Patients are open to participating in trials during a pandemic but prefer to use digital means to participate remotely. It appears many are realizing numerous benefits of virtual clinical trials.
Why do patients choose virtual clinical trials?
- Safety: Site visits are stressful, especially during a pandemic.
A pre-pandemic survey found that nearly 40 percent of clinical trial dropouts found facility visits “very/somewhat” stressful. As COVID-19 continues to ravage the United States, patients are not only stressed about visiting a clinic, but fear that it could lead to infection, so they are avoiding doctors’ offices and hospitals altogether. Since the start of the pandemic, visits to primary care physicians’ offices have dropped by 60 percent. What’s more, ACRP has seen an alarming 10 percent increase in the number of suspended checkups in the last months.
Virtual research eliminates these concerns by allowing patients to participate in the study from a secure location while maintaining virtual communication with the research team.
2. Accessibility: no geographic restrictions.
In traditional clinical trials, the pool of participants is often limited by the location of the site. The patient must live within commuting distance, which is particularly difficult with rural and suburban populations rarely within the study’s reach.
Therefore, experimental treatments may be inaccessible to those who need them most; 85% of patients are willing to participate in clinical trials, but nearly 70% live more than two hours away from the research center. Looking at the fact that there is no specific location for virtual trials, sponsors can write protocols that allow patients to live anywhere in the world. An example is ObvioHealth, which recently conducted a completely virtual dermatology study with participants from 48 U.S. states.
3. Flexibility: less disruption to daily life.
It can be difficult for some populations, such as working people or single parents, to find free time. While these people may live close to a trial site, their life circumstances – childcare or scheduling concerns – are major barriers to participation.
A 2018 report from Tufts University shows that the complexity of protocols has increased significantly over the past decade, with the total number of endpoints collected increasing by 86 percent. This data demonstrates the increasing burden on patients. With the ability to virtually participate in trials, patients can complete tasks on the go or at home, with little disruption to their daily routine.
What does it all mean?
Virtual clinical trials is the new trend for all those visits that can be done remotely and do not require a physical presence at the facility.
Site visits pose many problems for clinical trial sponsors, especially during an ongoing pandemic. However, research can continue with minimal risk to all involved if conducted virtually. Patients are adapting quickly, and as virtual becomes the norm, convincing participants to join traditional trials will be difficult.