Ongoing concerns about a global shortage of clinical research associates (CRAs) were rekindled last week at the Clinical Trial Collaborations conference in Boston, Massachusetts, prompting debate about the reasons for and solutions to the problem—and particularly about a two-year experience requirement described by many as arbitrary.

A 2015 study found that, within the U.S., there were at least 10,000 open CRA positions. Observers believe the shortage of qualified CRAs is significantly impacting the pharmaceutical industry, resulting in higher costs and delaying drug development timelines, especially in emerging markets and key therapeutic areas such as oncology.

“There has been an exponential demand and growth in the clinical studies space in the past five or 10 years,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). “We have a shortage not only of CRAs, but of investigators, clinical coordinators and more. The entire industry is under stress with the amount of research that’s being conducted and the resources available.”

There has been a bit of finger-pointing surrounding the CRA shortage. Should CROs have anticipated a shortage? Do enough academic institutions offer defined pathways? Should efforts have been made earlier to develop a set of core competencies for the job? Are sponsor companies being unreasonable by requiring two years of experience for CRAs?

Sheryl Jacobs, vice president of Global Study Operations at Amgen, believes CROs could have done more to help avert the shortage. “Many sponsor companies like Amgen have been moving to outsource CRA models over the past several years,” she said. “So there was an influx of CRAs who were leaving sponsor companies and joining CROs. Given that a lot of that activity is winding down, we’re curious why the CRO industry didn’t anticipate that was going to happen. We don’t have any more to give, so they needed to start growing them from the ground up.”

Cynthia Verst, president of Clinical Operations at Quintiles, a major provider of biopharmaceutical development and commercial outsourcing services, said that predicting the extent of the shortage was complicated. Outsourcing, mergers and acquisitions, and an unprecedented number of FDA approvals contributed to a perfect storm that has created “a real call to action” in the industry, she said.

While there has been some dissent over various reasons for the shortage, most agree that a major issue is the industry-wide practice that requires CRAs to have a minimum of two years of experience before being assigned to a trial. ACRP, among others, is working to change that mindset, while still ensuring quality in the profession.

“The most important factor [concerning the shortage] is the requirement of two years of experience before being considered a qualified CRA,” Kremidas said. “It’s a random marker. Time in a job is not necessarily indicative of whether somebody does it well or not."

Kremidas described the situation as a catch-22. “Sponsors don’t want to take on CRAs who don’t have the two years’ experience, but how are you supposed to get that if no one will hire you? We know a lot of qualified people who would like a role as a CRA, but can’t get organizations to speak with them because of this arbitrary requirement.”

Laurie Halloran, president and CEO of Halloran Consulting Group agrees that change is needed. “There’s no demonstration of competency after two years,” she said. “It’s really an arbitrary number. And there has never been a consistent way that’s recognized as the minimum standard to assess someone’s level of competence before they can be hired as a CRA.”

Amgen’s Jacobs said that identifying core competencies for CRAs is key to addressing the issue. “Do CRA skill sets have to be what they were 30 years ago, or with the advent of technology can we think about different skill sets?” she said. “That’s probably the next industry discussion: what skill sets are needed and how they can evolve. And maybe that’s slightly different from what a CRA looks like today.”

Quintiles is taking a three-pronged approach to address the situation internally, Verst noted, including offering a competitive salary, outlining a distinct career pathway within the organization and simplifying procedures with the use of technology to ensure a better work-life balance.

In addition, Quintiles has refined an in-house training program to ensure that CRAs can develop the experience the market is seeking. “This magical two year number is the continuing challenge we face,” she said. New hires “may not have two years of clinical research experience, but they surely can have research experience in different venues. Then we put them through a very rigorous training cycle complete with competency checkpoints.”

Stephen Sonstein, Ph.D., director of the program in Clinical Research Administration at Eastern Michigan University, points out that there are dozens of excellent academic programs across the U.S. to prepare candidates for a CRA career. He connects the shortage directly to the two year experience prerequisite.

“It’s not that the individuals who come out of academic clinical research programs are not appropriately qualified,” he said. “In many cases, they’re better qualified because they have a much deeper knowledge of the clinical research enterprise. Many of them have experience already, through internships and preceptorships. It’s the two year requirement that’s created an apparent shortage.”

Sonstein was among a group of clinical research professionals who served on The Joint Task Force for Clinical Trial Competency (JTF), which developed a set of core competencies for CRAs. “The goal is to try to move the industry into saying experience is a not a criterion, but if in fact you meet these competencies, you should be hirable,” he said.

ACRP is a keen advocate of this approach, Kremidas said. “We suggest throwing the two year arbitrary experience requirement out the window and focus on the competencies required for the job,” he explained. “We’d like to define an industry standard that everyone agrees upon, one that says if a person has this type of education, training and experiences, they are qualified to be a good CRA.”

Lisa Catanese, ELS, has been a medical writer and editor since 1986, covering clinical trials, medical research, newly approved drugs and devices, consumer health education, continuing medical education and more. She is a member of the American Medical Writers Association and is certified by the Board of Editors in the Life Sciences. Email Lisa@BlueBlazeCommunications.com.

This article was reprinted from Volume 20, Issue 12, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »