Should clinical researchers meet competency standards?

Competency and Commitment

Clinical researchers have to balance increasing demands on their time with maintaining a patient-centered approach. Sometimes, professional standards are not meeting the reality of the positions.

In the December 26 issue of Clinical Leader, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP) raises the question of whether it is necessary to have competency standards for clinical researchers. As he says,” For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do…Sometimes, in the midst of hectic workdays and meeting the increasing demands on our time, it can be easy to forget. We cannot let that happen.”

When discussing the importance of raising the standards of professionalism of the clinical research workforce with representatives of CenterWatch, a source of clinical trials information for clinical research professionals and patients, Kremidas stresses the importance of driving this change, showed how new standards could improve workforce performance and talked about public trust in clinical research. He discussed the lack of consistency in the training, development and assessment of professional competency that could impact performance.

With new technology, new regulatory requirements and more demands from patients for “a more proactive and central role,” clinical researchers must be equipped to meet staggering new challenges. However, Kremidas asserts that “ our staffing mind-set is not keeping pace with market realities.” He believes that the most critical problem is for entry-level personnel, because “there is no standard path for becoming a clinical researcher.”

While there is a shortage of clinical research associates (CRAs), there is an “arbitrary requirement of two years of experience rather than using any measure of validated competence.” People who simply have tenure are not industry-certified as having “mastered the latest skills and best practices.” Instead, Kremidas believes that “entry should be based on demonstrated skill sets as regulated by recognized training and certification.” He thinks the profession needs “new CRAs, study coordinators, and other professionals while we ensure incumbent personnel are keeping pace with new standard operating procedures and other performance metrics.” According to Kremidas, it is necessary to keep demonstrating clinical trial integrity, encouraging more patient participation and showing “competency and high standards” among personnel.

Unfortunately, training programs at sponsoring organizations, contract research organizations and individual sites vary widely, and there is no uniform way to determine performance. Kremidas recommends establishing “a standard methodology and competency level for clinical researchers who come into the industry” to “reduce the variance and improve workforce quality.”  He also believes that the perception of clinical trials would benefit “if patients had proof the investigator in their trial is not only a physician and the coordinator is not only a nurse,” but instead had specific credentials to conduct clinical research and keep patients safe. The industry, he says, needs to “come together to establish standards and monitor ourselves to make certain we have competent professionals conducting these critically important activities.” If those in the industry fail to establish and monitor standards, the government could get involved.

Kremidas concludes, “Yes, it’s a big challenge. Yes, it will require a paradigm shift in the way we operate. However, if we are going to fundamentally improve the quality of research, we need to come together and address this issue.”