Combining Innovative Technology with Face-to-Face Encounters to Help Improve Operational Efficiencies at Research Sites
Author:
Ipsita Chitre, Clinical Trials Engagement Specialist
Research sites are a big part of the heart and soul of clinical trials. These sites are where patients are evaluated and potentially treated for a variety of conditions. Without a strong research site infrastructure, drug innovation would not be possible. However, sites face many challenges when executing trials, such as staffing constraints and difficulty finding patients for trials.
To better understand these challenges, Verana Health conducted 10 site visits across California, Florida, New York and Tennessee, between March and August 2023. Our goals were to:
- Identify the pain points of the clinical research coordinators and clinical research managers.
- Learn about systems and processes the sites utilize on a day-to-day basis (e.g., CTMS, patient identification, IWRS, recruitment, patient visit scheduling).
- Build a rapport with the clinical research coordinators and clinical research managers.
Verana Health’s onsite visits have allowed us to better understand the challenges that sites face, when executing trials.
Onsite observations
The sites that our Clinical Trials team visited echoed the same recruitment challenges that have been revealed in recent site surveys. Those challenges include:
- Cumbersome patient recruitment processes – The majority of sites found the patient recruitment process to be complicated and time consuming.
- High turnover rates among staff – Sites note high turnover rates are leading to a need for consistent staff training and knowledge transfer.
- Complexity of clinical trial protocols – Sites are facing difficulties adhering to trial protocols, possibly due to their complexity.
- Multiple technology platforms – Managing and maintaining information across multiple technology platforms (e.g., CTMS, EDC, etc.) posed a challenge, especially for large-volume practices.
- Desire for User-friendly systems:
- Sites are looking for user-friendly systems that require minimal training to provide patient lists of potentially eligible candidates.
- One site conveyed that it had been dealing with the complexities of certain clinical trials and finding the right patients in electronic health records (EHRs). The site also shared that staff turnovers and challenging protocols are major concerns.
- Another site, which has been conducting multiple competing trials, noted challenges with various tools and technology for patient identification for each protocol. The site also expressed a desire for a simplified tool which is less time-consuming and cumbersome.
Overcoming challenges with Verana Health solutions
Verana Health is utilizing the following tools to help research sites address many of the above aforementioned challenges. These tools aim to address patient identification and trial and technology complexity:
- Verana Trial Connect (VTC) – Provides clinicians and research staff participating in clinical trials with a curated list of their own practice patients that have a high potential for study recruitment. Using VTC, the research staff, cross-references patient records to specific inclusion and exclusion criteria for trials that are offered in the application.
- VeraSite – A site selection tool that may help clinical trial sponsors identify practices that have specific patient populations that fit their clinical trials and provide insights into impact of certain inclusion and exclusion criteria on the eligible trial population.
Verana Trial Connect and Verana Research Network in action
A New England research site was experiencing difficulty finding and recruiting patients for a Phase 3 trial on advanced neovascular age-related macular degeneration (wet AMD), due to competing trials and capacity issues. Since this site is part of the Verana Research Network (VRN) – an expanding clinical trials network of active trial locations affiliated with therapeutic-specific medical societies – Verana Health was able to seamlessly provide the site with a Verana Remote Coordinator (VRC), who was able to utilize the VTC database and EHR system to locate potentially eligible patients. The VRC was also able to identify additional notes on upcoming appointments, which was crucial for the site. The end result was an increased amount of screenings at the site. The VRN site found the integration of VRC to be instrumental in overcoming recruitment challenges and expressed interest in utilizing this service for future trials.
VeraSite as a future solution
During our face-to-face encounters, many sites expressed frustration over not having the correct, or right amount of trial opportunities. Verana Health’s new VeraSite tool is poised to help alleviate such frustration. Prior to the official launch of VeraSite in 2024, Verana Health has already successfully matched many principal investigators and sponsors, utilizing the data that powers VeraSite. The following example helps demonstrate the potential of this tool:
A small site in a suburban area had some experience but a difficult time being selected for trials, perhaps due to being positioned in a densely populated geographic area. Using de-identified, curated real-world data from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight), Verana Health was able to showcase the site for a number of trial opportunities. The site was selected for a Fuchs’ dystrophy trial, largely due to the ability of VeraSite to demonstrate the site had an attractive patient population that fit the study protocol.
Addressing challenges with Real-world Data and Engagement
The success of VRN and VTC in helping sites better attract clinical trials holds great promise for the future of trials. Verana Health’s onsite visits have allowed us to better understand the challenges that sites face, when executing trials. This valuable feedback will continue to be essential as we improve our existing tools and launch new ones, such as VeraSite.
Verana Health is dedicated to combining its innovative technology and high-quality real-world data, with site engagement, to help address challenges across the clinical trials landscape.
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