During the site qualification visit, the site appeared to be the perfect match for for a rare disease clinical trial I was working on. One of the first things I had asked was about the patient population. I wanted to ensure they could meet the minimum enrollment requirements we needed for this study. While other sites predicted a maximum enrollment of 3 patients, this site predicted 12. Naturally I was shocked and thought this was odd. It did not seem realistic in this patient population and the study coordinator had contradicted the large number given to me by the investigator. Mind you, this was not a large university setting type clinic, but rather a small stand alone clinic. Still, all else seemed adequate for study participation and I had no reason to doubt the Investigator’s sincerity so I decided to recommend the site for participation.

The time came for the site initiation visit (SIV). During the visit, I asked again about the number of patients that could be enrolled for the study. The number had changed from 12 patients to 6 patients. Half of what they had promised at the site qualification visit. While I was not happy, I was not shocked as this was closer to the number that other investigators had estimated.

Three months after the SIV, the site had yet to enroll the first patient. I was making weekly calls to the site to check on the status of enrollment. Each week there was a different reason why they had not enrolled. Eventually they stopped answering the phone and responding to my weekly contacts. The site was eventually closed out without having enrolled a single patient. They had promised the world at the site qualification visit but failed to deliver. While this can be justified in many cases, given the cost of clinical trial start-up, high enrollment numbers promised that are outliers to others are view with a bit of skepticism.
Doris Yadav RN