Lack of Standardized Competence Putting Clinical Trials at Risk

Jim Kremidas, ACRP Executive Director

Clinical trials will remain at risk of continued variance in research conduct quality if workforce development and standardization of competence and career paths are not prioritized, warns Jim Kremidas, Executive Director of the Association of Clinical Research Professionals (ACRP).

While many initiatives are bringing forth excellent technology solutions to clinical development, ACRP is focused on standardizing and enhancing competencies of the people who ultimately conduct clinical trials at the grassroots level.

“There is no standard path for becoming a clinical researcher. Most people gain knowledge on the job, and organizations utilize disparate onboarding and training programs,” Kremidas notes. “This creates a tremendous amount of variance in research conduct, processes, and workforce competence, which culminates in a detriment to research quality.”

Look no further than the persistence of common U.S. Food and Drug Administration (FDA) inspection findings for proof that the current approach to workforce development is not working.

“ACRP’s mission is to promote excellence in clinical research, so we are leading several initiatives to standardize workforce development and improve clinical trial quality,” Kremidas says.

ACRP is playing a central role in developing clinical research professional competencies through the Joint Task Force (JTF) for Clinical Trial Competency, a multi-stakeholder group seeking to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards. The JTF, which includes representation from the Clinical Trials Transformation Initiative, Multi-Regional Clinical Trials Center, Pfizer, and more, has proposed eight core competency domains for clinical research professionals and is working to fine tune them and begin advocating their industry-wide adoption.

“This is the first step on a long path toward standardizing competence in clinical research and a critical one in eliminating a significant variance in operations,” says Kremidas.

ACRP is also leading an initiative to identify and advocate a set of core competencies required of entry-level clinical research associates (CRAs)/monitors. Convened in December 2015, the multi-stakeholder CRA Workforce Development Task Force includes representation from leading contract research organizations (CROs), sponsors, and more.

“There is a major shortage of CRAs in the workforce,” Kremidas notes. “As a result, sponsors and CROs are battling CRA turnover and substantial compensation increases. At the same time, it’s clear from our own data and continued FDA inspection findings that there is an insufficient level of knowledge, skills, and abilities in the CRA workforce.”

ACRP believes the root cause of the CRA shortage is prioritization of a 2-year experience requirement over validated competence.

“Competency based on tenure discourages a talented pool of potential CRAs who lack an industry-imposed, calendar-based requirement from trying to advance and fill the rising number of open positions,” Kremidas says. “The current system in place to train and mentor new CRAs is demonstrably inadequate to meet a growing demand for new skills and talents.”

Meanwhile, ACRP is providing innovative market solutions, including an 8-week CRA Onboarding program recently delivered to a global pharmaceutical company. A year after the program, the client retained 93% of the CRAs who participated and reported significant improvements in operations.

“By leveraging fresh ideas we have the power to improve clinical trial operations, and it starts with the workforce,” Kremidas says.