The post-pandemic world of clinical research will offer a stark contrast to its predecessor.
Hundreds of studies in the U.S. have been suspended since early-March, and researchers must now, with the support of the FDA, seek out alternative methods of data collection – notably, virtual and site-less trials, to ensure participant safety.
It is our conviction that companies that reconfigure their protocols to support a virtual trial model during the COVID-19 outbreak will find themselves ahead of the curve in the post-pandemic world.
There are five distinct advantages of virtual research that point to its solidification as the “new normal”:
When recruitment is managed through a physical site, meeting the enrollment goals can be a slow and inefficient process. Site-based enrollment restricts sponsors, bounding them by the distance a participant is willing to travel to get to the clinic for appointments. These boundaries make it harder to recruit, often extending timelines.
Virtual study designs makes digital recruitment possible anywhere – untapped participant populations are targeted via social media and optimal matches are rapidly enrolled without the need to schedule appointments.
People-centric research places emphasis on the participants’ needs during protocol design; this is easily done in a virtual setting. Participants find it difficult to continuously visit a physical site to complete study-related tasks and often quit the study before its end. By streamlining communications and minimizing site visits, virtual studies reduce the burden of labor-intensive tasks. Subjects are more likely to comply and thus less likely to drop out.
In today’s world, digital natives feel comfortable using smartphones for just about anything, including research. Post-COVID-19, this behavior will extend to many who have adopted digital practices out of necessity due to social distancing. The world will discover how a digital research platform can enable completion of study activities, allow for constant contact with the research staff and offer reminders or study-related push notifications to keep participants on track and engaged. Having experienced the benefits of remote research, neither sponsors nor participants will want to go back.
Site-based studies dictate that health-related data be collected in a lab or clinic. Yet most of the experiences studies seek to capture occur at home, at work, or during some other aspect of daily life.
When participants scramble to fill out study-reports on their way to the clinic at the last minute, they are often unable to remember their detailed activities, leading to recall bias. Consequently, data points are lost, and data accuracy can be compromised.
In a virtual clinical trial, participants can report and record their data in real-time, at the precise moment they experience the symptoms and/or interact with the study products. The result is more real-world data (RWD).
Centralized data collection means that all data flows from users into one virtual site. Data requires no re-entry, participants don’t need to recollect the events later on, thus limiting opportunities for error.
A digital system accelerates response times to potential health risks, making it less likely that an adverse event goes unreported.
Digital databases can be monitored constantly by the research staff who capture data in real-time and can spot health-related issues. Should a participant show elevated blood-pressure levels or have a negative reaction to the study product, the research team is notified immediately… no need to wait for the next doctor’s appointment.
And of course, when contagion is an issue, minimization of site visits increases safety – both for health workers and patients.
The are many reasons why traditional site-based studies are expensive; we can pinpoint recruitment and physical site operations as two of the key drivers.
Physician referrals are no longer the most efficient way to enroll participants. Often, sites can’t find enough patients and adding new sites to fill the gap is cumbersome, time-consuming and expensive. As the burden placed on a participant intensifies, (i.e. multiple lab visits) higher compensation is also expected. This is why site-based studies often see costs rise exponentially before enrollment is complete. Remote recruitment and remote-based monitoring can provide comparable results for a fraction of the cost.
Not all studies are an optimal fit for the fully virtual design: early-stage and high-risk research will likely require hypervigilant safety monitoring. However, certain components of even these more complex protocols can be conducted digitally.
Prior to COVID-19, the thought of integrating such virtual options was little more than a theory for most researchers. Now that this theory has become lived experience, the advantages of going virtual will reverberate through the industry for years to come.