By Ann Neuer

October 23, 2018 | There is a very real onslaught of technologies overwhelming investigative sites, which raises concerns as to whether site staffers have the expertise and comfort to work with all or even some of these tools. To understand what’s involved in becoming proficient in the expanding cadre of tools, and how they impact quality and conduct of clinical trials, the Association of Clinical Research Professionals (ACRP) is diving head first into this subject. 

In 2017, the organization established the Workforce Innovation Steering Committee (WISC), which is a group of executives from member organizations representing private and public stakeholders. Their intent is to standardize competency expectations and address the widely reported technology challenges faced by clinical research coordinators (CRCs) and clinical research associates (CRAs).

Now, ACRP is collaborating with Forte, a provider of clinical research solutions to cancer centers and academic medical centers, to develop a survey focused on the status of competencies and why many study performance measures are worsening despite the growing presence of technology across the enterprise, including at the site level.

Still in the pre-planning stage, the ACRP-Forte survey hopes to explore why this is happening. Is it because end users are not adequately trained? Is it a change management issue? Should there be better use of what is already available instead of adding more solutions that may not be compatible with existing tools?

Beth Harper, ACRP Workforce Innovation Officer and a member of the survey development team, tells Clinical Informatics News, “It could be all of these factors. Certainly, stakeholders need to focus on adoption of technology with support from senior management. And there’s the issue of competency.  End users need to be trained and then evaluated for their ability to use the increasing number of tools. We are trying to better understand the competency gaps and how we can help clinical research professionals gain confidence and competence in working with the many technologies infiltrating the clinical research industry.”

A Tough Scenario

Getting to the root of systemic problems with technology starts by understanding how sites generally operate. CRCs are often charged with learning to operate multiple systems and portals, ranging from study startup tools to study conduct solutions, each with its own login and password, user interface, and functionality. Moreover, the task of training study volunteers to use study-related technology tends to fall to the CRC, as research suggests that many volunteers, especially those age 60 or older, prefer to be trained in person. So, CRCs need to be trained in those tools, as well. Similarly, CRAs must learn to use an array of systems, including the electronic trial master file, as well as risk-based monitoring tools, which may present challenges for interpreting data, outliers, and risks.

The approach is not resulting in improved clinical trial outcomes.

Recently, Forte released the findings of its survey entitled 2018 The State of Technology in Clinical Research, which states that many stakeholders are struggling to adopt technology, but as it assumes a larger role, there are some positive results. Data from 619 respondents were analyzed, mostly representing academic medical centers (30.2%) and research sites (23.6%). They were asked about their use of eleven different systems, with most (61.6%) reporting use of five or more systems. Electronic data capture (EDC) and registration systems (interactive voice response systems - IVRS) were the most heavily used, at rates of 86.8% and 66.7% respectively, and often for more than five years. Also, nearly 80% of EDC users and 63.7% of IVRS users stated that they had received extensive or moderate training on these solutions.

Not surprisingly, given the longtime use of these two technologies and the level of training, approximately 90% of EDC users and some 80% of IVRS users claim to feel “very comfortable” or “somewhat comfortable” with them. In addition, respondents generally reported that technology had a positive impact on site productivity, including 65.5% of EDC users and 61% of clinical trial management system users.

The data do suggest that the amount of training a respondent received on a system impacts perceptions of that system. While this finding was not statistically significant, it hints at a trend that those with more extensive training tend to view the system as having a positive impact.

So, what’s the problem?

Harper points to several, linked specifically to the number of solutions, and the fact that oftentimes, they do not embed well into a site’s workflow. “Sites sometimes feel that sponsors provide systems that are not consistent with how sites operate,” she says. “In some of these instances, the sites resist the technology because they may not be comfortable with it or feel it’s being forced on them.  And there’s the issue of so many portal interfaces, not all of which are user friendly.”

Denise Snyder, Associate Dean for Clinical Research at the Duke Office of Clinical Research, makes a similar observation. With 356 therapeutic studies in accrual mode and more than 4,000 studies across the university, Snyder states that site personnel may resist some of the new technology due to its impact on familiar workflow. 

“It’s not that these solutions are necessarily hard, it may be about making the time to learn the specifics of each one, and workflow may change as a result. For example, every sponsor is doing something different with EDC, so if a study coordinator has an average of five studies, that means he or she has to learn five different systems on top of all of their other responsibilities,” she explains.

Snyder adds that there are several factors that contribute to ongoing inefficiency. Adequate support and training, volume of work, and competing studies are just some of the reasons why the introduction of technology does not automatically translate into greater productivity.

The Upcoming Survey

Details of the new survey are yet to be hammered out by ACRP and Forte, but according to Shree Kalluri, CEO and founder of Forte, it will likely have a sharp focus on process-related issues, including where industry is getting it right and where more work needs to be done. A survey that could uncover what kinds of new and ongoing training are needed, and how competencies should be defined, would be a valuable resource.

As Kalluri explains, “The industry has done a good job of developing technology, and processes are getting better, but improved competencies are the link to greater efficiency and adoption. We need to understand what skills are required, and then we need to figure out the best way to train sites on the various technologies.”

Orla Mester, Forte’s Senior Vice President, Services, adds, “We want to explore how tech savvy coordinators need to be, given that one of biggest barriers to technology adoption is the lack of comfort with new systems. Many coordinators have been in the field for decades and do an amazing job, but struggle with the move to EDC and other technologies. To better understand this, we’ll be looking for trends in the data.”

Mester says Forte’s earlier survey shows that the percentage of people who receive continuing training is encouraging, and the emphasis on training across the organization is critical. “This is a top priority, instead of taking a ‘you’ll learn it along the way’ approach.”

As the clinical trials sector moves into adapt and adopt mode for technology, stakeholders will be watching to see what kinds of changes the future holds. Jennifer Byrne, CEO and Board Chair of Javara Research, an Integrated Research Organization, comments, “We are on a journey right now, one with twists and turns, but there are positive signs. Many vendors that provide technology tools to sites are beginning to offer more synchronized solutions. My prediction is three years from now, we will have advanced toward a more collaborative and efficient enterprise that works in better harmony with the healthcare sector. Data from various sources will be more actionable, facilitating better patient access to clinical trials, and driving better efficiencies for all stakeholders, including sites.”