How Effective are Site Questionnaires in Predicting Site Performance?

The use of site questionnaires in the site selection process is a time-consuming feature of almost every clinical research trial. Are they worth the effort, time and expense spent on them? Lasagna observed that "Investigators overestimate, many fold, the pool of available patients who meet the inclusion criteria and would be willing to enroll in a particular trial. " 1 Spilker discusses this phenomenon: “There ‘always ’ seems to be one or more inclusion criteria that eliminate patients the investigator considered likely candidates. The investigator’s optimism may reflect surreptitious behavior to obtain the clinical trial from a sponsor, or it may reflect inexperience or naiveté. ” 1 Herschel suggests that information returned on site questionnaires should not be taken as fact, as some sites are “overly optimistic ” and will not accomplish what they state they can; others have “selective listening ” and will try but fail; others are “grandiose ” and say they can accomplish any goal; while others just do not truly understand the challenges of the trial.2 Kibby estimates that “approximately one-third of selected sites perform ineffectively, another third perform marginally, and the upper third meet or exceed enrollment. ”