Clinical Trials Workforce of Tomorrow Must be Better Trained, More Diverse

Kenneth A. Getz

Kenneth Getz, MBA, Deputy Director and Professor, Tufts Center for the Study of Drug Development

Tomorrow’s clinical trials workforce will face demands and expectations almost unimaginable today. To thrive, the workforce is going to need a new level of training, greater diversity, and richer understanding of so-called “soft skills” such as communication to take clinical trial quality, efficacy, and efficiency to the next level, says a new white paper from the Tufts Center for the Study of Drug Development (CSDD).

The white paper, “Drug Development Workforce in the Age of Digital Transformation,” is an outgrowth of the December 4, 2019 Senior Leadership Roundtable convened by Tufts CSDD to discuss the current state of the drug development workforce as it enters the digital era. Sixty executives from pharmaceutical and biotechnology companies, technology-solutions companies, professional trade organizations, and academia participated in the roundtable. Participants’ functional expertise included clinical practice, clinical operations, data management, regulatory affairs, human resources, digital technology, and research and development strategy.

“Roundtable participants largely acknowledged that the successful workforce of tomorrow will need to develop the softer skills and competencies that contribute to collaborating effectively with increasingly diverse global open innovation teams; thinking resourcefully and analytically; having deep curiosity; and acting with agility and flexibility,” said white paper coauthor Kenneth Getz, deputy director and professor at Tufts CSDD in the Tufts University School of Medicine. “A diverse workforce is integral to this new era,” he added.

“We are taking active steps to help promote diversity in the clinical trial workforce,” noted ACRP Executive Director Jim Kremidas, a member of the Senior Leadership Roundtable. “We believe by diversifying the clinical trial workforce, it will lead to greater participation of minority populations in clinical trials, and thereby provide better data for clinical decisions for these underserved populations,” he added.

It’s also time for the industry to take a much more “proactive” approach when it comes to clinical trial workforce training, Getz noted. “In the past, the industry falsely assumed that digital transformation and disruption would be gradual, isolated to individual functions, and fairly easy to accommodate,” he explained.

However, as the clinical research enterprise has evolved and learned more—through internal and open team assessments, pilot testing, and actual experience, and through observing how other sectors in the economy have responded—it has acknowledged that much “more strategy and planning are needed throughout the organization, beginning with the highest executive levels,” Getz said. “Training will be helpful, as will more effective ways of communicating and presenting data,” he added.

Specifically, the white paper also calls for offering mentorship and training programs geared toward individual needs. Staff can be trained through both bottom-up and top-down training methodologies. According to the white paper, these include “in-house experiential training, simulation programs, hackathons, coding camps, and other off-campus training programs. Creating an environment that fosters and rewards constant self-learning is of paramount importance.”

Workforce development should not end there, however. “Now that some of the newer roles have been identified through this effort, the industry needs to define the competency requirements for each role, align around those requirements, and validate that our workforce possesses those competencies,” said ACRP Workforce Innovation Officer Beth Harper, who is also a member of the Senior Leadership Roundtable.

Author: Michael Causey