The background work that I must do to screen a volunteer for a study is extensive. But as I’ll explain below, the time and effort can be worth it, even if the patient doesn’t qualify for the study.
First, I’ll set the stage for you. The volunteer has the condition that the clinical study is researching and really wants to be in the study. With regard to the study requirements, the volunteer looks like a great candidate. The volunteer has fully participated in the Informed Consent process, so the next step is to complete the “screening” visit. Typically, the
screening visit will include a doctor visit, blood work and an EKG (a painless cardiac test) and perhaps additional more specialized testing as required to ascertain if the volunteer is appropriate for the study and that the volunteer can safely participate.. Basically, the screening visit is where the rubber hits the road in terms of the volunteer continuing on in the study. It sometimes happens that volunteers don’t meet all the study entry criteria and are therefore a “screen failure.” Failure! Really? Not so fast.
I once had a volunteer who looked like a great candidate for a study but at the screening visit he had an abnormal EKG that ultimately disqualified him. I had to inform the volunteer he could not continue, and the study doctor referred him back to primary care for follow-up. I saw the patient a week or so later, and he looked me right in the eyes and said “you saved my life.” Now, I’m not sure if the situation was actually quite this dramatic, but the screening process had uncovered a potentially serious cardiac problem for which the patient was now receiving treatment. So, was this really a screen failure? Not at all.
Here’s another example. I was screening a volunteer for a research study; he was really struggling with his health and was just not doing well. During the course of screening for the study, I determined that, for whatever reason, the volunteer was not using prescribed medications as directed. I spent as much time as necessary to educate this patient on the proper use of medications. Eventually, this volunteer also screen failed for entry into the study. But, we later found out the patient was doing much better than he was before screening for the study because he was using his medications appropriately. So, was this truly a screen failure? Nope.
The moral of my blog today is that sometimes failing is … good!
– Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center
