Clinical Researcher—February 2023 (Volume 37, Issue 1)

TRIALS & TECHNOLOGY

Laura Araujo, MEd

 

In a little more than two decades, the volume of clinical research studies has grown exponentially with little sign of slowing down. As medicine progresses, researchers have expanded the breadth of treatments to address a wider range of health problems.

While this growth is certainly good (the clinical research market is expected to reach $8.8 billion over the next five years), it comes with its share of challenges. Clinical research sites lack the human talent to conduct the bureaucratic work of clinical research, greatly restricting the potential of many clinical study sponsors in the field.

A BDO report published in 2023 found that clinical research associates (CRAs) experience a turnover rate of 32% of in the United States. Overall, the industry has seen nearly a 10% decrease in staffing levels, creating first a manpower crisis and secondly, a training challenge to keep staff qualified for participation in clinical trials.

Managing Design Complexity

As medical treatments become more specialized, clinical trials also rise in design complexity. Combine complex design with staffing shortages, and site leaders will definitely find themselves with trial delays either from long start-up timelines or extended deadlines that further delay clinical studies.

Clinical trial design has advanced faster than some technology solutions available to site personnel. As a result, clinical sites often rely on legacy systems, both internally and provided by trial sponsors. In addition to the scientific complexity in today’s protocols, they must often sort through complex technical requirements for each study. This results in a time-consuming and arduous process that often overtaxes those completing the work. The increased likelihood of human error can lead to inaccurate data requiring multiple systems edits to clean the data throughout the study and especially before the study ends.

The challenges contribute to an industry at a crossroads. There is ample opportunity for those who can overcome staffing issues and employee burnout to take advantage of the countless new studies waiting for clinical research sites that are adequately prepared to handle them.

The Need for New Solutions

Next-generation technology for randomization and trial supply management (RTSM) has emerged as a solution, replacing legacy systems commonly referred to as the old interactive voice response systems (IVRS). RTSM empowers sponsors to design complex clinical trials while keeping the site’s user experience simple, allowing for more time tending to test subjects and not handling data entry or interpreting technical requirements.

Clinical sponsors have typically leveraged either waterfall or agile software methodologies in their RTSM design. Waterfall has served as the traditional method for developing systems. Similar to coding, waterfall methodology collects all customer requirements at the beginning of a project and then builds a system to meet those requirements.

However, today’s waterfall methodology can no longer keep up with complexity demands as it lacks the agility and speed necessary to make changes as the study protocol and treatement options evolve. It fails to address changes quickly and ultimately presents research teams with an increased workload thanks to lengthy change orders. Risk management was not a typical element of waterfall development; therefore, changes introduced to a live system often took significant time and resources to implement, and often included focusing on elements that were not high priority to the study. With legacy systems, this is even more difficult since it may require specialized resources and lengthy testing and validation cycles.

Modern RTSM systems use an iterative process that enables user-friendly, early, and continuous delivery of the configured solution. Agile design methodology incorporates feedback and multiple design reviews during the requirements-gathering process to nimbly adjust designs as the system is built. An iterative build process also highlights high-risk areas of the design early, allowing teams time to discuss design options and mitigate risk by streamlining the design. Risk management and flexible, yet managed, change control systems are essential for this model to be successful. Even more significantly, there are seldom design changes during the testing and overall validation process in iterative development models. Multiple design reviews early on mean no surprises later, so testing can be laser-focused on verifying that results match requirements.

Once the system is in the hands of clinical sites, the continuous feedback loop of agile design ensures an intuitive experience for sites that can alleviate a CRA’s workload and burnout. This facilitates the randomization side of RTSM, ensuring that sites can randomize with confidence. The trial supply management is equally important and a modern RTSM will pre-emptively order materials before they run out to keep the supply chain turning smoothly. Single sign-on capabilities in most RTSM systems makes it simple for site staff to log into just one system and access all of the trials that they might be working on.

RTSM can help minimize waste, as well as time, while leveraging computer processing to alleviate human input for data entry and other manual tasks. Clinicians spend more time doing research work and avoid the burdensome tasks that lead many to leave their current positions or the industry altogether.

The Path Forward

The clinical research field finds itself at an exciting point. The growth of clinical research and the demand for research services provide an ample business opportunity. For those in the field, this growth leads to new career opportunities and research programs that can spark their intellectual curiosity.

To manage this growth, clinical researchers must rethink how they operate. Manual processes and extended timelines do not meet modern needs. Clinical organizations need agility and resilience to manage this onslaught in work, and that means using agile and resilient tools.

As clinical trial sponsors look at their operations, they should look for efficiencies in each process. For many, that includes leveraging RTSM technologies, supply chain management best practices, and new ways of easing the burdens on clinical sites.

Take the steps now to prepare your organization for this imminent future. Today’s efforts can provide immense dividends with increased capability and a happy and engaged clinical staff. The worker shortage will continue until employees feel heard and are happy in an environment that fits their needs. Leverage RTSM to improve operations and employees at your clinical sites will likely stay more engaged.

 

Laura Araujo, MEd, is Vice President for Quality at 4G Clinical in Massachusetts.