Lack of Standardization Hinders Clinical Trial Workforce Opportunities

Jennifer Byrne, Former CEO of PMG Research & Co-Founder of Greater Gift

Jennifer Byrne, Former CEO of PMG Research & Co-Founder of Greater Gift

Standardization and high-quality training are keys to recruiting and retaining more principal investigators (PIs) for running clinical trials, according to panelists at the Clinical Trial Collaborations conference in Cambridge, Mass., on April 11.

Luckily, the tools are available today.

“This is a very encouraging time,” said Jennifer Byrne, founder of the Greater Gift Initiative, during a conference session.

Byrne advised contract research organization leaders and others not to reinvent the wheel by developing their own disparate educational programs. For example, “ACRP [Association of Clinical Research Professionals] is doing some amazing things” to promote training and standards, she said.

“Be aware of what’s already out there rather than creating your own,” she added.

To be effective, however, training and standardization must keep pace with the incredible “change and churn” going on in the clinical trial industry, said Jim Kremidas, executive director of ACRP.

“It’s not easy to become a PI,” Kremidas said. Protocols, amendments, and feasibility are increasingly complex, he noted. Perhaps not surprisingly, studies have found that nearly half of physicians never run another trial after their first experience with one.

There’s one obvious factor at work, according to Kremidas. “Just because you are a doctor or nurse, does not mean you’re going to be good at clinical research, though that’s the traditional expectation,” he said.


Advances in Competence and Career Path Standardization Initiatives – Make sure you’re prepared to be part of the clinical research workforce of the future! Join Byrne and others at ACRP 2018 this month to learn about collaborative initiatives to standardize professional competence and career paths in clinical research. Session attendees will learn about the Core Competence Framework for Clinical Trial Monitoring and hear a case study on its use in AstraZeneca’s initiative to internalize its monitoring program. Updates on development of the Core Competence Framework for Clinical Research Coordinators will also be shared. View Session Details

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To thrive as a PI, “you must also have realistic expectations along with a recruitment plan,” Kremidas said. He offered advice on how to engage in proper planning before committing:

  • Assess the feasibility of conducting the trial
  • Have a good source of patients
  • Have full understanding of the PI’s roles and responsibilities
  • Understand the costs and time you will incur to conduct the trial

Another challenge: a lack of clear standards and guideposts for new industry entrants. As a result, the professional entrance path is haphazard, at best. Whether it’s “working as a former shoe salesman, or the manager of a trucking fleet,” there’s no clear logic to how people enter the clinical research field, Kremidas said. “It’s a major problem.”

However, no bells and whistles will have much impact if the clinical trial industry can’t connect on an emotional level with the patient population.

“We must design our communications to people who have no idea about what we do,” said Jonathan Jackson, PhD, director of the CARE Research Center with Massachusetts General Hospital. That’s a serious challenge, he said.

“Most Americans don’t know a single scientist,” Jackson said. “They might know Neil deGrasse Tyson and Bill Nye, but those guys aren’t out shilling for clinical trials.”

Author: Michael Causey