Error is the most effective learning tool, so remain open-minded when assessing a site
Everyone has the occasional poor performance in clinical research. Study coordinators may fail to report a serious adverse event.
Monitors may overlook an incorrect version of an informed consent form. Without the occasional failure, we would not progress—in learning, adapting or growing as clinical researchers. Error is the most effective learning tool, with the dual outcomes of compliance and retention.
Researchers continue to strive for the perfect medication to cure disease without side effect or great cost, and though impossible to achieve, the pursuit inspires the innovation required for this challenging profession.
A continuous string of strong performance can make anyone feel invincible. But error-free performance sometimes can prevent the understanding necessary to correctly interpret the reasons for someone else’s deficiency. Empathy is as important as innovation. My own “sub optimal” performance at a study meeting gave me the empathy necessary to overlook a deficient first impression of an otherwise valuable site.
I was asked to conduct a last-minute study meeting with an investigator at a well-known academic institution. It was imperative the sponsor add this particular therapeutic expert to its site roster for credibility. Unfortunately, the busy investigator was available to meet only at 7:30 a.m., requiring me to fly from east to west coast with little time to prepare. In retrospect, I should have rescheduled the meeting. But the experience taught me an invaluable lesson.
On the morning of this important meeting I struggled to prepare, to concentrate and to retain customary study information. I was severely jet lagged and had slept poorly the night before. I knew this protocol well and had discussed it with other investigators. However, familiarity with the material does not guarantee an orderly presentation. I felt uncharacteristically nervous when I arrived at the site.
The investigator was surprisingly low key, which was reassuring. However, her onslaught of questions regarding the delivery and action of the compound, prior studies and available safety data throughout the protocol review threw me. Several times I drew a blank, though I knew the information. And that set the tone. I fumbled my way through the slides, confusing a bit of the enrollment information. I left the meeting disappointed in my performance.
Several weeks later, I was in the lobby of an endocrinology practice waiting for a study nurse who was running late for our site selection meeting. My concern mounted after 15 more minutes; the site was in a small town with limited flights. I had a small window in which to finish the meeting and catch my flight.
The study nurse arrived five minutes later. I was relieved and ready to start. Unfortunately, she was not ready; she needed to print slides, confirm the investigator’s timeline and grab us coffee (she insisted). The meeting now was 30 minutes behind. I was concerned about the late start and the overall disorganization.
When the study coordinator returned, she offered an insightful explanation that touched me. “I hope you know that this is not how I really am. I worked late last night and had a terrible night’s sleep. I have been struggling all morning. I am truly sorry for this."
Her words brought me back to my own unfortunate experience a week earlier. I could sympathize with what she considered “atypical performance.” I told her, with all sincerity, that I understood how she felt. Her relief was apparent. Then we started the meeting.
The study recruitment discussion transformed the nurse into an efficient and engaging participant. She pulled up a list of diabetes study patients she could filter based on blood sugar and HAIC results. She had generated a patient list based on key eligibility criteria for our study that had resulted in 10 potential patients she was eager to screen.
She then began to explain the socioeconomic advantages of the region in relation to the indication, explaining the prevalence of diabetes was strong in the demographic due to fiscal and cultural factors. Additionally, the impoverished residents had limited treatment due to poor, or no, insurance coverage. The possibility of free treatment would promote enrollment and retention in the study.
The investigator was enthusiastic about participating. The site had a good track record.
My first impression of her had been a poor predictor. The site was organized and experienced, with facilities/equipment very sufficient for study conduct. I left encouraged by the prospect of its participation in the study. I could not reconcile the disorganized individual at the start of the meeting with the impressive individual who had so effectively concluded the meeting. I was thankful my experience allowed me to keep an open mind.
Empathy created clarity, which resulted in wonderful innovation.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and business development director. She currently works in relationship development/study startup in the CRO industry.
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