Clinical research complexity continues to rise, but collaboration between research stakeholders is not keeping pace. This was one of several findings that came to light in a recent survey of more than 200 clinical research professionals across the enterprise, revealing disconnects that could hinder trial execution in 2025 and beyond.
The survey results, which included responses from staff at clinical research sites, sponsors, and contract research organizations (CROs), highlight significant barriers to collaboration while offering concrete steps to overcome them.
When asked to describe their working relationships, nearly half of site staff used the word “complicated.” While two-thirds of respondents at sponsors view their relationships with sites as collaborative, only half of those at sites say the same about sponsors. The relationship with CROs fares even worse—just 31% of respondents at sites describe these interactions as collaborative.
Even as the members of these groups endeavor to be collaborative and make concerted efforts toward that goal, they are all failing at it. Particularly troublesome is the site view of CROs, since CROs not only are involved in nearly every Phase II and III trial, they also serve as the main point of contact for sites. The site-CRO relationship is thus critical to effective operations and collaboration.
Technology’s Crucial but Inadequate Role
One of the findings of this survey is that the same technology meant to streamline trials, instead, often creates new barriers. Site and sponsor technology systems plus trial vendor systems combine to force sites to juggle as many as 22 different systems—with all the unique user IDs, passwords, and two-factor authentications that come with each of them—per trial. Research coordinators spend up to 12 hours weekly on redundant data entry—in other words, additional, duplicative data entry. About 60% of site staff regularly copy data between systems, increasing the risk of errors. These figures highlight the inefficiency and frustration sites face.
In addition to staffing shortages and the challenges of complying with new and existing regulatory expectations, sites lack proper training for the staff they do have working. Only 29% of sites report adequate training on new technologies and procedures. The key factors leading to poor training include training methods that don’t reflect an understanding of the vast research on cognition and teaching principles, and clinical research associates (CRAs) who are not themselves thoroughly trained on the protocol and the technology used in the trial.
In fact, protocol deviations, often stemming from poor communication and insufficient training, remain the top cause of Warning Letters issued by the U.S. Food and Drug Administration. In too many cases, the trainers have had minimal training themselves, often not having done more than read the exact same document the trainees have read (in this case, the protocol). Training ends up being more about checking a box for completion rather than making an impact on the successful enrollment and patient recruitment of a trial.
Some successful approaches for addressing the issues of communication, training, and even technology include establishing consistent points of contact between sites and sponsors, standardizing communication protocols, integrating the myriad technology systems, and creating training programs geared toward true knowledge sharing, including sharing best paths to success.
As trials become more global and complex in the year ahead, the need for better collaboration between research professionals will only grow. Organizations that invest in integration—of their people, processes and technology—will be best positioned to conduct successful trials and advance new treatments for patients. All stakeholders in the clinical research enterprise can help by advocating for centralized, integrated systems and mitigating the burdens discussed here to improve workflow efficiency.
Working together, we can each play a pivotal role in reshaping the clinical research landscape. By fostering collaboration and advocating for integrated technologies, standardized training, and consistent communication protocols, we can help ensure that trials are conducted ethically, responsibly, and efficiently in all their diverse settings around the world.
Contributed by Christine Senn, PhD, CCRC, CPI, FACRP, (christine.senn@advarra.com) Senior Vice President for Site-Sponsor Innovation with Advarra and the 2023 Chair of the ACRP Board of Trustees.
