Industry experts call for professionalism in clinical research

Quality Matters

Are people who run clinical trials seeking to bolster their professionalism? If not, maybe the time has come for a new approach, according to some experts in the industry, opined Michael Causey in a blog offered by the Association of Clinical Research Professionals (ACRP).

Speaking at the Drug Information Association (DIA) 2018 Global Annual Meeting in July, Robert O’Neill, the U.S. Food and Drug Administration’s (FDA’s) senior statistical advisor for the Office of Translational Sciences in the Center for Drug Evaluation and Research, told attendees it was time to advance professionalization in the clinical trial industry. Saying that federal regulations requiring more evidence of a “quality by design” approach to clinical trials were less than two years away, he explained that the agency’s agreement with current ICH E6(R2) guidelines for Good Clinical Practice from the International Council for Harmonization showed the FDA’s “culture change,” which requires that clinical trial practitioners devote attention to quality issues, rather than just “checking a box” when doing studies.

Citing the consequences of site quality variation, ACRP Workforce Innovation Officer Beth Harper, MBA, told DIA attendees, “Variations contribute to data integrity and patient safety” shortcomings, among many other downsides. Also, the lack of clearly defined career paths and ongoing challenges from job dissatisfaction among professionals keep triggering high, expensive staff turnover rates.

Ken Getz, director of sponsored research programs and associate professor at the Center for the Study of Drug Development (CSDD) at the Tufts University School of Medicine, said, “Quality is moving in the wrong direction. We need a new approach. Industry is fragmented and spinning its wheels in a bizarre cycle where we never achieve consistency. Year in and year out, nearly 50% of principal investigators (PIs) are one and done, meaning they conduct a single study and then drop out of the clinical trial business.”

While common sense and collected data suggest that certification improves individual and site performance, new data are very convincing. New evidence shows that credentialed, ACRP-certified staff do better in quality and efficiency measures. With certification there are fewer protocol deviations and faster enrollment, according to an ACRP WIRB-Copernicus Group (WCG) study analyzing global information across 65,000 investigators and 7,000 active study coordinators.

“As professionals, we all need to support certification,” said Jeff Kingsley, DO, MBA, CPI, FACRP, founder and CEO of IACT Health and immediate-past chair of the Association Board of Trustees for ACRP. He promotes study coordinators when they achieve their Certified Clinical Research Coordinator (CCRC) status, because it demonstrates a higher level of competency.

“Certification is definitely a measure of quality,” added Suzanne Caruso, vice president for clinical solutions at WCG, explaining that the new research that found much higher levels of performance among ACRP-certified professionals as compared to their non-certified peers. ACRP-certified PIs and research coordinators attained the lowest deviation rates 85% of the time, as compared to their peers. The difference was even more significant when looking at the “high number of deviations” category with ACRP-certified PIs and CRCs falling into this category less than 10% of the time. “When segmenting site performance into four quartiles, 78% of the ACRP-certified investigators fell into the top two quartiles of enrollment performance and similarly 63% of the time, ACRP-certified coordinators captured the top two quartiles of faster enrollment rates,” Causey’s article said.

According to Harper, workplace challenges are growing. Site performance, which is highly unpredictable now, will be more volatile in the future because of the increase in rare and stratified diseases coupled with fragmentation, low volume, inexperience and high turnover. “We can solve many problems through staff credentialing,” she concluded.