Personnel Problems in Clinical Trials

Worker shortages, uneven performance top list

Despite the many advances in instrumentation and procedures, the clinical research sector still faces a major hurdle, reports Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), on the website www.outsourcing-pharma.com: both a shortage of workers in several categories including investigators, coordinators and site monitors, and the uneven performance and variability among research personnel. In the article, “A turning point: Examining the clinical research workforce in 2018,” he makes a case for bringing more people into the workforce and imbuing them with the appropriate skills to succeed.

These problems are likely to get worse as the number of clinical trials continues to grow. They grew from 231,208 to 261,940 in only one year from 2016 to 2017, according to www.clinicaltrials.gov.  

According to Kremidas, “While some of that uptick can be explained by new reporting mechanism and policies, the bulk of it reflects a booming industry with a workforce that may not be able to keep up in the coming years. One solution: Standardizing the way we onboard, develop and assess clinical research professionals.”

He adds, “We need to set a standard methodology and competency level for clinical researchers who come into the industry. Doing this properly wil reduce the variance we struggle with today, improve the quality of the workforce and, consequently, improve the quality of research.”                                                                                                                       

Harvard University has now formed a Joint Task Force for Clinical Competency that will try to address these problems by standardizing requirements and qualifications for clinical trial personnel. Variation among workers doing the same jobs with different research outfits is thought to lower the quality of results and the confidence that can be placed in them.

That insufficiently prepared or qualified workers exist is thought to be shown by the repeated warning letters issued by the Food and Drug Administration (FDA) to research outfits for the same error. These include failure to follow the experimental plan, to comply with FDA regulations, to keep full and meaningful records, to be open about negative results and to obtain proper informed consent.

Increasing public confidence in the professionalism, competence and reliability of clinical trial personnel is seen as critical.

In addition to Harvard’s Joint Task Force, the research industry itself is now sponsoring two study groups, the Workforce Innovation Steering Committee and the Alliance for Clinical Research Excellence and Safety. These will examine the existing workforce, define specific skills and abilities needed for each job description and develop ways of measuring employee performance.

While these efforts may bring about standardization in clinical research, they do not address the other personnel problems of shortage, recruitment and retention. Still, Kremidas is “optimistic that 2018 is going to be a turning point” and is happy to “be part of the effort to examine the workforce and how we use a competency-based model to standardize how identify, onboard, develop and assess clinical research workforce personnel.”