The staffing shortage in clinical research is an undeniable problem that’s only growing worse. Sweeping, radical change is needed to overhaul the current system for hiring new personnel, say industry leaders, particularly regarding restrictive experience requirements that currently bar entry to many promising candidates.

The workforce issue, which may very well be hitting sites the hardest, is explored in depth in a new Association of Clinical Research Professionals (ACRP) report written by ACRP’s Partners Advancing the Clinical Research Workforce, a consortium of leaders from across the industry stakeholder spectrum. Now is a pivotal moment for industry to band together on addressing this critical problem, Susan Landis, executive director of ACRP, tells CenterWatch Weekly.

“The clinical research industry has an unprecedented opportunity to join forces to address the global workforce challenges so that all stakeholders in clinical research succeed,” Landis said. “The risk is real — the workforce will not keep up with the trial workload and drug development will slow.”

Among a number of proposed solutions for moving forward, the group presents two key areas that industry should focus efforts on: raising awareness of the clinical research profession and, critically, doing away with impractical experience requirements for entry-level positions. Work is already underway in these areas, but more remains to be done, they say.

The latter — most commonly seen in job listings as a requirement for two years’ worth of experience — has wide-reaching impacts, both on bringing fresh minds into the workforce and on working with existing staff, with an end result of keeping the candidate pool limited, the report says. There currently is no evidence that these job experience requirements have any actual benefit and they need to be looked at keenly, according to the group.

“It appears to be based on a supposition that has been perpetuated for decades without scrutiny. That’s not an acceptable situation at the best of times but, in the midst of an escalating workforce shortfall, it becomes truly pernicious,” the authors wrote. “Many indications already exist that college graduates who have taken programs of study in clinical research and/or undergone dedicated internships would be eminently suitable entry-level candidates whose experience and training could be further enhanced ‘on the job.’”

Rigid restrictions on getting into clinical research also mean that tussles over existing staff are amplified. In the current climate, companies are fighting tooth and nail to offer more appealing packages in the hope of drawing away talented individuals who aren’t easily replaced or readily available. In particular, sites have lamented these challenges, particularly when they’re up against big tech companies that have more competitive levels of resources and benefits, but even CROs and sponsors are pulling talent away from sites, they’ve said.

“The result has been an alarming rate of churn in the profession, with serious adverse effects on organizational productivity, operational continuity, team-building and morale,” the experts wrote.

As they see it, there are two paths forward: show, through research, that the two-year experience requirement is justified and subsequently establish clear pathways for gaining such experience; or make entry into clinical research easier by coming up with qualitative experience requirements based on clearly defined standards and competencies.

The Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital and Harvard’s Joint Task Force for Clinical Trial Competency, a global team of investigators, educators and research professionals, has developed a framework of competency areas needed to achieve high-quality, safe and ethical research that would serve as a strong starting point for a new approach, ACRP says. It’s also important that any new model accounts for transferable skills possessed by those wishing to move into clinical research from another profession.

Once a replacement model is defined and validated, it will be important to achieve industrywide adoption and determine what it actually translates to in practice. Once this is done, ACRP would be in a strong position to develop a comprehensive guide on this new model, the report states. This guide could also be complemented by a “playbook” and template for human resource teams that simultaneously emphasize the need for inclusivity and diversity, another prime area of discussion.

Some sponsors have acknowledged the experience requirement problem already and worked to address it. Merck, for example, has seen success with its Early Talent Rotational Program, according to Leslie Wolfe, the company’s director of global clinical trials operations. Notably, they created an entry-level position that doesn’t require two years’ experience and set up pathways for new recruits to rapidly move on to other clinical research roles, including clinical research associate, data manager, clinical scientist and regulatory affairs specialist. The initiative was successful in opening doors for non-intern, new graduates who otherwise may not have gotten a shot.

PPD also takes a similar approach through its Clinical Development Academy, which recruits, hires and develops select college grads, people early in their careers and mid-level professionals who all have skills that transfer to clinical research but little to no experience. The program offers them professional networking opportunities, senior-level mentors and other resources designed to help them gain guidance and experience.

The other focus area identified in the report, raising awareness about careers in clinical research, is also essential to meeting greater demands and expanding the pool of staff in research, and a number of efforts are being undertaken that serve as strong case studies.

In academia, for example, the North Carolina community college Durham Tech has established a specific clinical trials associate curriculum that, in collaboration with industry hiring managers, is forging alternate paths around barriers into clinical research, helping connect candidates with opportunities and educating future workforce members on practical skills for entry-level positions. The initiative is working well to help fill staffing vacancies, says Sharleen Traynor, fieldwork coordinator/instructor for the program.

The University of California, Davis (UC Davis) spearheads an innovative program for training clinical research coordinators that provides both educational classes and hands-on clinical research exposure. The program has been successful in training the next generation on the core competencies of CRCs, says Angela Griffiths, education program manager at the UC Davis Clinical Trial and Translational Science Center’s Clinical Trials Office.

Overall, the ACRP consortium believes that in the face of an unsustainable status quo, the industry’s current way of recruiting and retaining staff “needs revolutionary re-thinking” and a “more insight-driven, more modern, more enlightened approach.”

Access the full report here: https://bit.ly/3Uddmco.