Competency

I am Dr. Jeff Kingsley and this is another edition of Riding in Cars With Researchers! What are we going to talk about today? We are going to talk about how you can figure out who is going to perform the best on research and which sites, physicians, Ph.D’s, nurses, and research coordinators. How do you predict which sites are going to perform the best on research trials?

To get to that answer we are going to talk about competence. Competence is complicated. You are not competent at your job just because you’ve done it for a long time. If you’ve done your job for a long time there is a greater likelihood that you are competent, but there are plenty of people who have done a job for a long time and yet they are still not very good at that job. How is that possible and why does it happen? Some people are good at engaging with other people – they are people-people. They bond with people well and make friends easily. Those people are more likely to get promoted and more likely to win jobs despite not necessarily being competent at that job. There are other people that are less experienced at engaging socially, and because of this, tend to have to be more competent in order to get a job, to succeed at that job interview, or to be promoted. Competence is complicated as is figuring out objectively who is really, really good at a job.

Certification

There is good evidence to show that certification is a great surrogate, a great predictor of competence. A research study was just announced this summer between ACRP (Association of Clinical Research Professionals), WCG in Washington (known for studying ethics and competency), and Tufts University’s Center for the Study of Drug Development (CSDD) out of Boston. These three organizations came together and looked at the relationship between ACRP’s certified individuals and outcomes in research trials. ACRP certifies Principal Investigators (PI’s), physicians or Ph.D.’s (typically) who run research, and Research Coordinators, who are nurses (typically), medical assistants who deal with patients and research protocols on a daily basis in research. The three organizations looked at non-certified PI’s and research coordinators; certified coordinators without a certified PI; certified PI without a certified research coordinator; and the combination of a certified PI with a certified research coordinator. What did they find? They found significant evidence that the combination of a certified PI and a certified research coordinator produces far better enrollment, better engagement with patients, and far better quality with fewer errors or protocol deviations. This is really meaningful, exciting data for someone like me.