Clinical trial transformation
Decentralization accelerates during pandemic, with positive results
A joint study released by THREAD, a global decentralized clinical trial (DCT) and eCOA provider, and Lokavant, a leading clinical trial intelligence company, showed that decentralized clinical trials far outperformed traditional trials in patient recruitment and retention during the first three quarters of 2020.
Although patient recruitment and retention dropped across the industry in early 2020 because of global quarantines and stay-at-home orders, decentralized trials rapidly returned to pre-pandemic recruitment and retention levels while traditionally designed clinical trials had yet to recover as of September 2020.
According to the report, “The COVID-19 pandemic has had a transformative impact on the delivery of clinical trials. The implementation of social distancing, quarantines, and stay-at-home orders has resulted in unprecedented delays and disruptions to operations across the globe, and thousands of trials have been suspended or stopped in 2020. The pandemic has also served as an accelerant for the adoption of technology-based innovations that have steadily been gaining traction for years.
“Perhaps the most significant evolution in clinical trial design and delivery throughout 2020 and into 2021 has been the widespread adoption of technologies to facilitate decentralization of clinical trials via solutions like digital recruitment, virtual visits, and eCOA captured via telehealth.”
The authors of the study began with the assumption that trials using THREAD’s decentralized trial platform rebounded quickly because they were already working with—or were able to rapidly add—decentralized technology features and services. In addition, the study demonstrated that DCT-enabled trials were able to pivot rapidly as different geographies shut down. Traditional clinical trials had greater difficulty doing that, in part because trial protocols, study technologies, and schedule of event designs precluded the adoption of decentralized approaches, according to the authors.
As John Reites, CEO of THREAD, explained, “This study is evidence that decentralized approaches are supporting sites and study teams to increase participant recruitment and retention in the more remote world that we now live in. Though the industry clearly understands the value, practicality, and promise of decentralized trials, it’s important for us to study, quantify, and report how these approaches positively impact clinical trials.”
The study was conducted to compare how well clinical trials performed using the THREAD DCT Platform versus those using traditional clinical trial processes with all site-based patient visits during the first three quarters of 2020. Study results were measured using Lokavant Insight, Lokavant’s clinical operations benchmarking solution.
“The study underscores the benefits of decentralized approaches in clinical trials by comparing trial methodologies through measurable operational data,” said Rohit Nambisan, president of Lokavant. “It also shows the importance of data-driven benchmarking, not only for developing a snapshot of relative study performance, but for planning studies effectively, managing trials proactively, and anticipating issues before they occur.”
The study explained that, according to the Society for Clinical Data Management (SCDM), one of the primary risk areas associated with clinical trials has been the dependency on research staff being continuously and physically on-site. Simple deviations to staff schedules, such as challenges to daily commute or personal leave, can cause delays to data entry and to site initiations and enrollments. As noted in the report, “In 2020, COVID-19 has transformed these constant background risks into pressing global issues. Several studies have sought to understand the broad impact of COVID-19 on clinical trials, but few have shown how this impact has differed between traditional site-based trials and those employing decentralized approaches for trial data collection. Now, more than a year after initial quarantines and stay-at-home orders took effect, we are able to start to understand whether the application of decentralized methods has allowed certain clinical trials to overcome these challenges.”
While the analysis is not supposed to be a comprehensive assessment of the impact of decentralized approaches on clinical trial success, the authors chose performance metrics relevant to clinical trial success and conducted the analysis to provide important information for industry, as research sponsors seek to integrate lessons from 2020 into future clinical trial designs. Additional analyses will be conducted in the future to supplement the analysis to more comprehensively and holistically address how decentralized trials fared in other performance focus areas against traditionally designed trials in 2020.
