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In the third part of our blog series exploring the results of our recent survey on the impact of COVID-19 and the shift toward decentralized trials, we are looking at the varying perspectives on these types of trials. As noted in previous blogs in this series, Mednet surveyed its customers in 2020 to understand how clinical trial teams viewed COVID-19 and how it impacted their work and the design and conduct of clinical trials. Several weeks ago, we conducted a second survey, asking many of the same questions, but also expanding the questions to assess the trend toward decentralized trials.  

Survey respondents indicated they see the potential for significant benefits across hybrid, virtual, and decentralized trials. Nearly two-thirds (64%) see accelerating patient recruitment as an important benefit, followed closely by improved efficiency (59%) and reduced costs (59%). Forty-one percent felt increasing patient diversity was crucial, and about a quarter (23%) felt the ability to engage underserved populations was a key benefit. These benefits represent an opportunity to expand clinical research to broader populations and potentially do it quickly and efficiently.  

Along with the benefits, survey respondents were also aware of significant challenges. Approximately three quarters of respondents (76%) listed data privacy and security, technological failure or loss of data, and participant comfort levels with limited or no in-person interactions as key challenges. Data privacy and security, and technological failures are closely tied to compliance, technical infrastructure, and validated systems and processes. Participant comfort levels require clinical trial teams to look at the entire participant experience, including engagement and education. It will be incumbent on clinical trial teams to vet patient technologies and design and build engagement programs that ensure adherence. These challenges may become more complex as outreach expands to underserved populations.  

Sponsors and Contract Research Organizations (CROs) are clearly moving forward with hybrid trials. All of the CROs responding to the survey indicated they are conducting or planning hybrid trials. Approximately two-thirds (67%) of both medical device and pharma / biotech teams are also conducting or planning hybrid trials.  

The numbers tell a different story for virtual trials. Not surprisingly, none of the respondents from medical device companies indicated they are currently conducting or planning a virtual trial. Only a third (33%) of CROs reported working toward a virtual trial. However, approximately two-thirds (67%) of pharma / biotech respondents are conducting or planning to conduct an entirely virtual trial. These numbers may reflect the common need for in-person device service visits and the need for site staff to access an investigational device throughout the trial. The higher numbers of pharma / biotech compared to CROs may also be indicative of a phased approach. Many clinical research teams evaluate and test virtual models on small, early-phase trials. This approach allows them to gain experience and develop best practices with virtual trials while limiting risk.  

Only one-third (33%) of pharma / biotech respondents reported planning or conducting a decentralized trial. With the current popularity of the topic and the number of recent industry initiatives increasing, we expect to see this number increase in the coming year. 

As clinical research teams prepare to support hybrid, virtual, and decentralized trials, they have an opportunity to rethink their processes and leverage technology in new ways. Eighty-three percent of CROs, 86% of medical device, and 75% of pharma / biotech respondents said a flexible platform is an important factor when evaluating a technology vendor. Since the industry is still early in adopting hybrid, virtual, and decentralized trial designs, flexibility will be necessary. This will be particularly true for CROs needing to support sponsors with various levels of requirements and experience in hybrid, virtual, and decentralized trials. As teams learn from their experience, adopt best practices, and implement new technologies, other essential and advanced technological requirements will most likely emerge.  

The Mednet team continues to monitor trends across the industry. We are actively translating requirements for hybrid, virtual, and decentralized trials into our product strategy. We understand our clients need the same level of support, regardless of the types or number of trials they are planning or conducting. Our prioritization of flexibility within the iMednet platform serves our clients well as they embark on the journey toward decentralized trials.  

Contact us to learn more about our flexible platform and how we can help your team efficiently plan and conduct your next clinical trial.