Clinical research sites face an information challenge that hinders efficiency and collaboration. As trial complexity increases, the multiple logins, devices, and spreadsheets site staff use to execute studies create siloed workstreams. In addition, each sponsor has its preferred software solutions for every trial, making collecting, accessing, and sharing data a tedious effort. The outcome is overburdened investigators who are stretched too thin.
The impact is significant on-site capacity and is likely why a recent survey report found that more than half of clinical sites struggle to take on new trials. A significant drop in physicians entering clinical research — from 5% to less than 2% annually — compounds the problem. Emphasizing the supply and demand imbalance, 29% of the sites that take on a trial fail to enroll patients.
Realizing that fewer sites are participating in trials, the industry is beginning to come together and address the core needs of research sites. Sponsors, CROs, and sites are discussing real challenges and solutions to improve trial efficiency at workshops and forums. This is an important step toward a solution.
The shrinking site staff, increasing tools problem
As demand for trial sites increases, the tools and training requirements reduce a site’s overall functional capacity. This creates a widening gap between need and capability, and the disparity directly affects the efficiency of clinical trials. Sites represent the core of clinical research because they run trials, gather essential data, and provide patient care. However, they are overburdened by study requirements.
At its heart, this is made worse by the technology meant to make processes more efficient. Without addressing interoperability challenges and improving site processes, the industry risks stalling innovation at the point where it is most needed. Using more technology isn’t the best approach, as over 60% of sites use more than 20 applications daily.
Three key challenges are driving this issue. First is increasingly complex study designs, where the growing number of data points and trial procedures complicate execution. For example, a recent Tufts Impact Report says phase 3 trials saw an increase of 41% in procedures, diagnostics, and lab work.
Personnel shortages are a significant factor in site supply as talent pools in clinical research shrink. Sponsor teams are similarly getting smaller. Coupled with the slowdown in doctors entering research and a lack of research nurses — one nurse per 10 open positions — the industry faces a human resource shortage.
Lastly, sites are asked to use too many different technologies. More than half of sites say managing multiple systems is their primary barrier to efficiency. Logging into various applications with different interfaces, configurations, and credentials frustrates staff and slows processes.
Developing a more holistic, industry-wide approach to clinical research
The industry’s approach to solving the site capacity problem has historically been to add more technology. While some larger sponsors and CROs have attempted to introduce internal portals for more consistency, these efforts fall short due to a lack of integration across trials.
A more holistic, industry-wide approach can alleviate the burden on clinical sites. Many sponsors are beginning to standardize processes and technology across trials for smoother operations. This aligns with what sites are asking for, as many express a desire for standard and simple approaches to trial execution.
A recent survey by the Society of Clinical Research Sites on site, sponsor, and CRO collaboration revealed that sites overwhelmingly prefer integrated systems and consistent adoption of solutions across sponsors and CROs. These sites call for a central platform that works across multiple sponsors and trials, reducing the number of systems they must interact with daily.
Sites can benefit from a standardized platform, reducing the number of applications typically used in a trial to a single system that integrates essential functionalities — such as document management, data collection, and regulatory compliance. This approach allows data to flow seamlessly, saving time for site staff focused on core research activities and patient care.
To address the varying requirements for each study protocol, the industry can apply universal best practices and standardized training programs. For sites, this change can significantly reduce the learning curve for new studies and, in turn, accelerate trial initiation and execution.
Collaborating with research sites to apply a more holistic approach to clinical research can help lower data duplication and minimize errors while improving accuracy. With standardized systems and processes, stakeholders can quickly share and access real-time data to make informed decisions.
Advancing clinical research careers
Beyond a more connected approach to technology, simplifying trial workflows can make clinical research careers more attractive. Trials with fewer administrative tasks can lower the chances of burnout among investigators and coordinators. The changes could encourage more professionals to remain in the field and make it more attractive to new graduates.
With a predicted growth rate of 9% per year, clinical research offers challenging and fulfilling work. Yet, it lacks the awareness to recruit new entrants. Getting clinical research added as a career on the U.S. Census Bureau is a positive first step the Association for Clinical Research Professionals (ACRP) is pursuing ahead of the next survey. The organization is requesting a new occupation code for clinical researcher under the 29-0000 healthcare practitioners and technical occupations code.
Awareness is key to driving growth in the field and helping make a dent in the clinical research workforce crisis. Enhancing career sustainability through improved work environments, competitive compensation, and professional development opportunities is also essential for long-term industry success.
Collaborating to move from a chaotic crisis to a unified solution
The industry is listening to research sites’ challenges and taking steps to address them. By integrating technology, standardizing processes, and giving site staff time to focus on what they care about (treating patients), sponsors and CROs can drive speed and efficiency in clinical trials.
Investment in building the workforce and making clinical research an attractive career is also necessary to ensure long-term sustainability. Training programs, incentives for clinical investigators, and improved site support structures help bridge the gap between supply and demand. Regulatory bodies and industry leaders can start by working together to establish policies that encourage the standardization of processes and data while promoting innovation in clinical trial execution.
These efforts are just beginning to scratch the surface. Working closely with sites, sponsors and CROs can deliver a more effective and scalable model for conducting trials. This transformation will ultimately benefit patients, ensuring that important new therapies reach those who need them most quickly and efficiently.
Photo credit: appledesign, Getty Images
Bree Burks has held various roles, including a bedside ICU nurse, research coordinator, team manager, and senior director of a large central clinical trials office across three leading academic medical centers in the US. She has been responsible for over 1,000 trials spanning all translational stages across 38 unique clinical departments. Bree has developed and implemented many technical solutions throughout her career to support clinical trial operations. She left Vanderbilt University Medical Center in 2019 to join Veeva where she serves as vice president of strategy for site solutions.
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