The COVID-19 pandemic has disrupted every aspect of the clinical trial ecosystem. Processes, models, technologies, etc. are all being reimagined and companies are rising to the challenge to seize this opportunity to create positive and sustainable changes. In this interview, Jim Corrigan, President and CEO of ERT shares his thoughts on how COVID-19 has impacted clinical development, how ERT is responding, and what we can expect in a post-pandemic world.
Q: How has the COVID-19 pandemic impacted clinical operations?
COVID-19 has impacted essentially all clinical operations to some extent and accelerated the evolution in virtual engagement dynamics between patients, sites, and sponsors. As a result they are now adopting, much more ambitiously, virtual trial technologies for keeping their studies on track, running more efficiently, and offering added patient convenience.
Pandemic-driven stay home mandates are causing clinical trial sponsors and CROs to question their dependence on patients’ access to investigative sites for routine aspects of clinical trial data collection. As a result, they are now considering, much more ambitiously, the role that virtual capabilities can play in keeping their studies on track, running more efficiently, and offering added patient convenience during and after the pandemic.
In fact, an industry survey we conducted last month showed that 82% are making changes to existing trial models because of the COVID-19 pandemic; of those, three-quarters are incorporating some virtual trial elements and some are going completely virtual. Notably, when asked how they are collecting patient data during virtual trials, the majority of survey respondents indicated patients will use devices and/or telehealth systems for important study data capture. (Figure 1). We anticipate that many in the industry will continue to leverage virtual trial capabilities well after the pandemic ends, based on the improved efficiencies these technologies offer to all clinical trial stakeholders.
Figure 1: Patient devices and telehealth systems are primary data capture tools in virtual trials (Source: ERT Survey, May 2020).
Q: How is ERT innovating in light of the global pandemic?
ERT has always been at the forefront of delivering innovative technology solutions that help our customers accelerate clinical development. We have accelerated our innovation pipeline to expand our virtual solutions across our endpoint collection modalities and increase the optionality our customers need to successfully execute their specific safety and efficacy endpoint data collection. Simultaneously, we are expanding our partnerships and collaborations with technologies that further increase flexibility and information capture.
For example, we’ve recently launched additional Virtual Visit capabilities that are enabling patients to easily interact with investigative sites, and our COVID-19 Dashboard is integrating data on coronavirus infection rates in geographic areas surrounding study investigative sites, so sponsors and CROs can identify and proactively intervene where patient and site compliance to study protocols may be at risk. In addition to our ‘At-Home’ solutions that enable investigative site personnel to capture respiratory and cardiac safety data when they visit patients’ homes, our Patient-Administered ECG Solution enables patients to easily conduct their own cardiac safety assessments from home by themselves, via a novel hand-held ECG device deployed in partnership with AliveCor (Figure 2). Of course, these examples are just the beginning of our innovations around patient centered end point capture across all modalities.
Figure 2: Cardiac data from the KardiaMobile 6Lis captured by patients and integrated into ERT’s software to ensure patient safety during virtual clinical trials.
Q: Have ERT’s business operations changed in light of COVID-19?
Throughout the pandemic, our imperatives have been ensuring the safety of our employees and our customers while continuing to meet our operational commitments. As a technology company, we’ve always embraced a flexible approach to work arrangements and many of our employees already work remotely. Shifting the entire company to working from home was essentially seamless. Our operations team took extra critical steps to ensure our supply chain was secured with redundant inventory geographically dispersed, and we deployed our business continuity plan to ensure we had safe staffing approaches in place to continue our logistics activities.
Q: What do you believe will be the lasting impact on clinical operations/R&D?
I believe many aspects of modern life will be significantly changed and clinical operations will not be an exception. One of the few positives from the pandemic is the opportunity to operate differently. All stakeholders have been forced to adapt and in many instances been surprised by the enduring benefits of digital virtual technologies.
I see a post-pandemic scenario where the industry emphasizes optionality and leverages advanced technologies to better engage patients in clinical trials and optimize in-person investigative site visits for important complex trial aspects that uniquely require the capabilities of site personnel. There will be more virtual site visits, which will minimize the need for patients to travel to investigative sites, and increased device integrations with consumer and medical data capture tools, all of which will simplify patients’ participation in clinical trials and improve their overall engagement. By doing so, the industry will benefit from more streamlined clinical trials, expanded patient engagement and accelerated clinical development times.
Jim Corrigan is the President and CEO of ERT