We lack specific hiring requirements. We lack clear entry-level opportunities and do an inadequate job of educating potential workers about the virtues of joining the industry. We lack well-articulated career paths that inspire and retain top talent.
Evidence of the problem abounds. Whether it’s consistent U.S. Food and Drug Administration (FDA) citations for trial misconduct, ever-increasing timelines, or rising trial costs, the consequences of white knuckling through with an ill-trained workforce is clear to see for those willing to look.
Clinical trials continue to evolve into increasingly complex and challenging projects for sponsors, sites, contract research organizations (CROs), and patients to undertake. A dizzying array of new technology options, a growing number of sponsor-demanded endpoints, and rising patient expectations are placing an ominous strain on a workforce starving for new talent and new ideas. For example, the Tufts Center for the Study of Drug Development reports total endpoints in trials grew by 86% from 2011 to 2015 as compared to the time period of 2001-05.
“If ever an industry was in need of change, it’s ours.”
Despite some advances in process improvements and technology tools, trial timelines continue to grow longer. According to Tufts, while start up and data management timelines in trials have remained relatively flat in the first 15 years of the new millennium, overall time to submission has slowed from 6.1 years in 2002-04 to 6.8 years in 2014-16. This suggests site level timelines are the rate limiting factor, and it could be due to capacity issues.
There are other troubling data points to consider: ClinicalTrials.gov reports a growth from 181,274 to 299,787 registered clinical trials between 2015 and 2019. That’s an increase of more than 65% in four years, and there’s no indication it’s going to slow down anytime soon. Clinical Leader magazine reports significant drug and device trial growth between 2010-17: Overall, trials were up 10% in terms of compound annual growth rate (CAGR) from 27,39 in 2010 to 53,793 in 2017. Device trials alone totaled 1,851 in 2010 compared to 5,006 in 2017, for a growth of 15.3% CAGR.
At the other end of the spectrum, the number of clinical trial sites isn’t keeping pace with demand. And clinical trial workforce professionals are stuck in the middle of the vise.
We also face a chronic personnel shortage ranging from disillusioned principal investigators (PIs) to ill-trained clinical research coordinators (CRCs) struggling to adapt to a revolution in the conduct of clinical trials. For example, Tufts reports the number of investigators grew from 28,521 in 2011 to 33,920 in 2015, about 19% growth. Unfortunately, many of these are so-called “one and done” PIs who bail after single trial.
Given those harsh realities, perhaps it’s not surprising to learn clinical trials are getting more expensive, too.
Yet if the problems are clear, so too are some potential solutions. For example, we have an opportunity to grow the clinical trial workforce by establishing clear career paths, defining the competencies required, and validating staff qualifications.
Growing the workforce and enhancing professional competency will also help to improve clinical trial efficiency.
The long-range prognosis is exciting: The ultimate goal of bringing much-needed drugs and devices to patients is in sight and attainable.
However, it will take new initiatives and an openness to a new way of doing things to turn the tide.
“If ever an industry was in need of change, it’s ours,” said Paul Evans, PhD, president and CEO of Velocity Clinical Research. “We’re inefficient” and need to do a better job of getting new drugs and devices to the patients that need them, he added. “We live in a period where there’s a very rapidly changing environment—probably faster than any of us have ever experienced in this industry.”
Here, we examine some of the underlying challenges facing the clinical trial industry workforce, along with some ideas about potential solutions to help speed new therapies to the patients who most need them. We also include a few options for clinical trial workforce personnel who’d like to become more involved in shaping the future of their 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 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.
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:
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 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:
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.
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:
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.”
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.
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.
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:
