Is the Clinical Trial Workforce Prepared for the Future?

STATE OF THE INDUSTRY

The demand for clinical trials is growing as the pool of clinical research associates (CRAs) and other trial workforce professionals is shrinking. It’s a stubborn problem threatening the very quality of trials and undermining the opportunity to bring more innovative drugs and devices to vulnerable patients.

However, far from being some absolute law of workforce physics, it’s in fact a fluid dynamic the medical research and development industry doesn’t have to accept, many experts insist.

“There are lots of talented people out there who want to get into the clinical field,” says Dietmar Eglhofer, CEO of VIARES GmbH. “We need to close that gap.”

There are a number of issues contributing to the problem, not least of which is the clinical trial industry’s relative weakness when compared to other industries in terms of attracting and retaining new talent. Airline personnel, hairdressers, car mechanics, and the like must all receive clear training and achieve certification to help clarify the roles and responsibilities of the job and ensure talented people with the right aptitude fill the much-needed positions.

“As an industry, we are missing out on so much great potential talent. Up until now, we’ve had no real answer as an industry to the talent shortage.”

However, the clinical trial industry has had no specific requirement before welcoming new talent into the fold. That’s a big mistake, and it has left the industry flailing to keep up with demand, says Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). “At a time when the demand for clinical trials has never been greater, we need to find new ways to bring in the next generation of professionals even as we train our current workforce to be even better,” he says.

“Having two years of experiences doesn’t necessarily correlate to quality performance in the workforce,” Eglhofer adds.

Last year, ACRP and VIARES GmbH announced a new strategic partnership designed to help train and certify a new wave of clinical trial professionals.

VIARES provides its growing customer base with on-demand, highly qualified CRAs, CRCs, and clinical trial assistants through its proprietary VIARES ACADEMY training programs.

Under this new partnership, ACRP’s professional support and development programs—including the industry’s most recognized and respected certification programs—are now integrated into the VIARES ACADEMY and immediately available worldwide.

“As an industry, we are missing out on so much great potential talent,” Eglhofer says. “Up until now, we’ve had no real answer as an industry to the [workforce] talent shortage.”

Looking ahead, Eglhofer believes we’ll see a significant shift in the industry over the next two to three years. “I think training and certification” will be viewed as equal or even superior to tenure as determinants of “employability” with new CRA entrants, he says.

CHRONIC PI/SITE SHORTAGE

Chronic PI turnover and related site shortages will continue to hold the clinical trial industry back until we do a better job educating and training vital new entrants, says Christina Brennan, MD, MBA, vice president for clinical research at Northwell Health Feinstein Institute for Medical Research. “It’s a real problem in our industry.”

The so-called “one and done” PI phenomenon—in which a new PI conducts one study and then decides not to take on a second study—is a serious issue for the clinical trial industry. A 2014 study by the Tufts Center for the Study of Drug Development counted some 40,000 PIs, with half being new to the job. In addition, although the highest turnover rates are observed among the least active investigators, turnover rates have been getting progressively worse among more active investigators.

“We have a tendency as an industry to rely too heavily on the same reliable PIs,” Brennan says. While this is understandable in the short term, “we won’t be able to move forward without engaging new PIs,” she adds.

Acknowledging the challenge is deep-rooted and tenacious, Brennan nonetheless sees rays of optimism when she looks into the clinical trial landscape’s crystal ball. For example, ACRP’s Functional Competency Guidelines for Principal and Sub Investigators should help slow personnel churn, she says.

“We have a tendency as an industry to rely too heavily on the same reliable PIs.”

“Many new PIs don’t realize what they’re in for when they sign up for a trial,” Brennan explains. ACRP’s guidelines will make it easier for new entrants to take an “eyes wide open” approach when contemplating clinical trial involvement, she notes, adding that “they’ll know what they’re getting into” in terms of time and financial commitments.

Too often, new PIs don’t realize the time they’ll need just to handle administrative and data signoff issues during a trial, Brennan notes. She also says new PIs don’t always understand they’re probably better off being a junior partner in a trial with an experienced PI on their first go around, or that they might want to focus on post-marketing or observational trials at first, as opposed to more complex trials of investigational new drugs.

In addition to tools like competencies, Brennan believes new technologies will continue to reduce the administrative side of the time burden for PIs. She also believes the industry needs to do a better job of promoting the virtues of clinical trial involvement to PIs. “We remind them it will help them become thought leaders in the industry, offer potential new treatments for their patients, and open new revenue streams” even as it improves healthcare for all, she says.

WORKFORCE SAGS UNDER HEAVY DEMAND

A “clear inconsistency” in site monitoring process outcomes during clinical trials is placing an “unsustainable” strain on the demand for and management of CRAs today—and it’s only going to get worse unless the industry reconsiders how it handles technology and workforce training, according to a new white paper from IQVIA.

“There is a need for new approaches enabling faster, less costly drug development models with a focus on operational trial conduct processes,” author Rajneesh Patil, head of process design, technology, and analytics clinical operations with the centralized monitoring services at IQVIA, writes in “The Clinical Trial and CRA of the Future.”

Further, risk-based monitoring (RBM) and centralized trials are reshaping the role of the CRA, changing the position into “more of an analyst and a quality auditor managing site motivation, compliance, and the relationship,” Patil writes. “As the monitoring paradigm shifts to more data-driven and eventually to a ‘direct to patient’ and ‘virtual trial’ model, the stack of activities that were performed by a CRA onsite begins to transform significantly owing to centralization of these activities.”

“There is a need for new approaches enabling faster, less costly drug development models with a focus on operational trial conduct processes.”

Patil envisions a new role for the CRA, with responsibilities centered around the following duties:

• Site quality management—Requiring a quality audit mindset and critical thinking.
• Analyzing insights from data—Rewarding analytical abilities for data-driven decisions.
• Site relationship management—Focusing on site motivation, training, and compliance.

Processes that require onsite visits will become limited to a particular set of activities like site selection, initiation, and activation; quality audits; and reviews requiring physical verification of trial processes that generate clinical data or manage patient safety while conducting trial procedures, Patil notes.

IT’S TIME TO GROW THE CLINICAL WORKFORCE

It’s a classic good news/bad news scenario. The bad news?  FDA officials keep finding the same operational problems over and over again during clinical trial site inspections, as evidenced by public Warning Letter reports. The good news? “Sponsors and sites are more open to the idea that we need more workforce training” to turn the tide, says Stephani Hulec, MS, CCRA, associate director of clinical monitoring services with IMARC Research.

“There are a lot of moving parts in a clinical trial,” Hulec notes, and “everyone is really busy doing things outside the study.” It’s no wonder problems slip through the cracks, she adds.

The list of common FDA inspection findings is woefully familiar, including:

• Failure to follow investigational plan/agreement and/or regulations
• Inadequate record keeping
• Inadequate subject protection, including informed consent issues and failure to report adverse events
• Inadequate investigational product accountability
• Inadequate communication with the institutional review board
• Investigational product represented as safe/effective

No one is criticizing the clinical trial workforce. “They are often not doing the job they were [originally] hired to do,” says Meghan Kulaszekwski, BS, CCRP, lead CRA with IMARC Research. Tasks are added on an ad hoc basis, and when a study coordinator leaves his or her post, often those duties are spread around to existing staff.

IMPROVE COMPETENCY AND LEVERAGE TECHNOLOGY

A December 2019 “state of the industry report” from Florence believes technology will impact clinical trials in five key ways over the next three years:

• Faster study timelines. “Real-time collaboration through technology will enable faster study timelines,” the report says.
• Reduced costs. Streamlined operations and workflows on integrated technology platforms will increase efficiency and decrease cost.
• More diverse participant populations. Remote technology will “enable the expansion” of trials to a wider geographical reach.
• Stronger regulatory compliance. Automated compliance tracking and security processes will ensure stronger compliance “across clinical trial operations,” according to the report.
• Safer clinical trials. Enabling remote monitoring of patients and more real-time data exchange with sponsors will result in safer clinical trials for participants.

There are a few caveats, however. For example, “successful adoption of technology at your research site requires an adequately prepared workforce,” the Florence report indicates. “The skills needed to manage clinical trial operations will be vastly different in three years.”

THE CLEAR VALUE OF CERTIFICATION

Adequately trained monitors/CRAs “will be prepared for just about anything” an increasingly complex clinical trial landscape is liable to throw at them, says Maggie Potrikus, BSN, CCRC, MBA, a quality assurance and compliance manager with Concentrics Research, a CRO, and former contracted CRA to Roche Diagnostics. On the other hand, “a lack of training means you won’t get the big picture and you’ll miss important things as a CRA,” she adds.

“Certification will be critical in the future,” says Potrikus, who is certified as a clinical research coordinator through ACRP. Already important today, it is only going to become more so, as the demands of clinical trials and the evolving workforce fundamentally change how trials are conducted, she notes.

For example, Potrikus sees a new “entrepreneurial spirit” entering the CRA workforce, meaning more CRAs will operate independently or work for multiple CROs. In that case, unchecked variance in performance standards will threaten overall quality. “I think ACRP can help fill that void with its [training for CRAs],” she adds.

“We value certification. It makes for stronger healthcare, it validates staff knowledge, and it’s attractive to sponsors.”

Training isn’t always cheap, and the benefits aren’t immediate, Potrikus acknowledged. However, failure to devote enough time and attention to training and certification is nothing less that “short-sighted,” she says.

“We need to take a step back and look at how we are conducting training as an industry,” says Jaylene Weigel, director of clinical research operations at Children’s Mercy Hospital at St Luke’s School of Nursing in Kansas City. She’s a big advocate of mentors and mentoring programs. “Mentors are especially critical during the first six to nine months on the job,” Weigel says.

A revamped training approach is critical if the clinical trial industry wants to become a driver of change rather than a reactor, says Christina Brennan at Northwell Health. “It’s hard enough to get any change in clinical research,” she notes, “and it’s going to happen even more slowly if we just train our CRAs to be what we’ve always thought them to be.”

It doesn’t take a rocket scientist to see the value of certification, according to Brennan. She sees the positive impact of certification every day on the job at Northwell, where she has overseen clinical research support personnel, PIs, and other staff with mentoring and training since 2015. Her team includes more than 300 total research staff, with some 75 of them being Certified Clinical Research Coordinators (CCRCs) through ACRP. They are currently engaged in nearly 375 active clinical trials.

“We value certification,” Brennan says. Northwell reimburses staff if they make a passing score and considers it a sound investment in the present and the future. “It makes for stronger healthcare, it validates staff knowledge, and it’s attractive to sponsors,” she explains.

Brennan is a big advocate of certification across the board. “I’m a big believer that it’s not just about [the investigators]—you’ve got to have qualified coordinators. They are necessary to study success,” she says.

Valuing certification at the top of the organizational chart also has a positive impact on morale and broader company culture, Brennan says. “Coordinators feel empowered, and even new entrants are yearning to take the exam” because they want to be part of the movement toward higher quality and professionalization in the clinical trial workforce, she explains.

CONCLUSION

The clinical trial industry is long overdue for a reassessment of how it operates and how it defines success. Variance is the enemy of quality, yet the clinical trial workforce is plagued by ill-defined core competencies, a lack of certifications and clear career paths, and an aversion to harnessing technology.

As an industry, we need to work together to define the competencies, gain professional alignment around them, and validate that the individuals conducting clinical trials have the necessary and vital expertise to do the job well.

However, there is growing support for promoting the further professionalization of the clinical trial workforce. It’s time to roll up our sleeves and get to work.

Patients deserve our best. With certifications, standards, and better training, we can give it to them.

HOW YOU CAN HELP

ACRP’s Partners in Workforce Advancement are working together to improve clinical trial quality and outcomes for patients by focusing where others have not—workforce planning, development, and assessment. Why? Because in clinical research, people are everything.

Partners in Workforce Advancement is a multi-stakeholder collaborative initiative to grow and expand the diversity of the clinical research workforce, and to set and support standards for workforce competence.

Partners in Workforce Advancement members—who include sponsors, CROs, investigator sites, academic institutions, regulatory agencies, and more—provide strategic direction and support for initiatives to:

• Grow & Diversify the Workforce > 
• Define, Align & Validate Competence Standards > 
• Support Sites During COVID-19 Pandemic > 

Get Involved