Clinical trials have research location demand and supply crises. Here's the solution to it
Information challenges faced by clinical research sites can hinder efficiency and collaboration. As trial complexity increases, multiple login, device and spreadsheet site staff use to perform research to show isolated workflows. Additionally, each sponsor has a preferred software solution for each trial, making it a tedious effort to collect, access and share data. The result is heavy investigators, they are too thin.
This impact is significant in site capacity, which may be why a recent survey found that more than half of clinical sites have difficulty accepting new trials. The problem is exacerbated by a sharp drop in physicians entering clinical studies (from 5% to less than 2% per year). Emphasizing the imbalance in supply and demand, 29% of the sites undergoing the trial were unable to register patients.
Realizing that there were fewer sites involved in the trial, the industry began to come together and meet the core needs of the research website. Sponsors, CROs and websites are discussing real challenges and solutions to improve trial efficiency of workshops and forums. This is an important step towards a solution.
Reduced on-site personnel and increased tool issues
As demand for trial sites increases, tool and training requirements reduce the overall functional capabilities of the site. This creates an expanded gap between demand and capacity, and the differences directly affect the efficiency of clinical trials. Sites represent the core of clinical studies as they conduct trials, collect basic data and provide patient care. However, they are overburdened with research requirements.
Essentially, this technology is designed to make the process more efficient. Without addressing interoperability challenges and improving field processes, the industry has the potential to stagnate innovation where it is most needed. Using more technology is not the best way to do it, as more than 60% of websites use more than 20 apps per day.
Three key challenges are driving this issue. The first is increasingly complex research design, where more and more data points and experimental procedures complicate execution. For example, a recent Tufts Impact Report says that procedures, diagnostic and laboratory work in the Phase III trial increased by 41%.
Due to the shrinking talent pool in clinical research, staff shortage is an important factor in on-site supply. The sponsor team is getting smaller and smaller. Coupled with the slowdown in doctors entering research and the lack of research nurses (one nurse in every 10 open positions) faces a human resource shortage.
Finally, the site is required to use too many different technologies. More than half of sites say managing multiple systems is a major barrier to their efficiency. Logging in to a variety of applications with different interfaces, configurations, and credentials can frustrate employees and slow down the process.
Develop a more comprehensive, industry-wide clinical research methodh
The industry’s approach to solving on-site capacity issues has historically been adding more technology. Although some of the larger sponsors and CROs tried to introduce internal departmental ports to improve consistency, none of these efforts fell due to the lack of integration throughout the trial.
A more holistic, industry-wide approach can reduce the burden on clinical sites. Many sponsors began standardizing processes and techniques in trials for smoother operations. This is consistent with the requirements of the website, as many express a desire for standard and simple methods of trial execution.
A recent survey conducted by the Association of Clinical Research Websites, which collaborates on site, sponsors and CROs, shows that the vast majority of sites prefer integrated systems and continue to adopt solutions in sponsors and CROS. These sites require a central platform that is available for use in multiple sponsors and trials, reducing the number of systems that must interact with each day.
Sites can benefit from standardized platforms, reducing the number of applications commonly used in trials to a single system that integrates basic functions such as document management, data collection, and regulatory compliance. This approach allows data to flow seamlessly, saving time for field staff focused on core research activities and patient care.
To meet the different requirements of each research protocol, the industry can apply common best practices and standardized training programs. For sites, this change can greatly reduce the learning curve of new research, thereby accelerating the initiation and execution of experiments.
Working with research sites to apply a more comprehensive approach to clinical research can help reduce 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.
Promote clinical research career
In addition to adopting more connected technical approaches, simplifying the trial workflow can also make the clinical research career more attractive. Trials with fewer administrative tasks can reduce the chance of burnout between investigators and coordinators. These changes could encourage more professionals to stay in the field and make it more attractive to new graduates.
The clinical study predicts a growth rate of 9%, providing challenging and fulfilling work. However, it lacks the awareness to recruit new entrants. Adding clinical research to the U.S. Census Bureau’s career is an active first step ahead of the next survey by the Association of Clinical Research Professionals (ACRP). The organization is providing new occupational codes for clinical researchers in accordance with 29-0000 healthcare practitioners and technical occupational regulations.
Awareness is key to driving growth in the field and helping to create a workforce crisis in clinical research. Enhancing career sustainability by improving work environments, competitive compensation and professional development opportunities is also crucial for long-term industry success.
Cooperation shifts from a chaotic crisis to a unified solution
The industry is listening to the challenges of researching websites and taking steps to address them. By integrating technology, standardizing processes, and giving field workers time to focus on what they care about (treating patients), sponsors and CROs can increase speed and efficiency in clinical trials.
Investment in building a workforce and making clinical research an attractive career is also necessary to ensure long-term sustainability. Training programs, incentives for clinical researchers, and improved on-site support structures help bridge the gap between supply and demand. Regulators and industry leaders can start by working together to develop policies that encourage process and data standardization while promoting innovation in clinical trial execution.
These efforts have just begun to scratch the surface. Working closely with websites, sponsors and CROs can provide a more efficient and scalable model for experimentation. This shift will ultimately benefit patients to ensure that important new therapies reach the people who need them as quickly and effectively as possible.
Image source: appledesign, Getty Images
Bree Burks holds a variety of roles, including a bedside ICU nurse, research coordinator, team manager, and senior director of the large central clinical trial office at three major academic medical centers in the United States. She is responsible for conducting more than 1,000 trials at all translation stages in 38 unique clinical departments. Bree has developed and implemented many technical solutions throughout her career to support clinical trials. She left Vanderbilt University Center in 2019 to join Veeva as Vice President of Strategy for Field Solutions.
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