Correcting Site Enrollment In 3 Steps
By Beth Harper, Chief Learning Officer at Pro-ficiency
Patient enrollment is a common subject of discussion among both sponsors and research sites. Challenges to enrollment can be myriad, and the root causes are hard to pin down. But effective enrollment is critical to the ultimate success of any clinical trial, and there are steps that research sites and sponsors alike can take to ensure that each site is capable of enrolling sufficient patients before they sign on for a particular clinical trial.
In theory, sponsors should be picking sites that have known patients that fit a protocol’s inclusion/exclusion criteria. But that does not always happen for a variety of reasons. For instance, a site may have access to many patients with a specified condition, but when it comes to enrolling in accordance with the
According to some estimates, fewer than 7% of sites enroll the patient numbers they promise, even though sponsors tend to cut site estimates of available patients by one-third to one-half to account for overestimation.
More sophisticated sites do this evaluation. Sites have to be more discriminatory due to tighter resources (personnel). Can’t take studies that are going to sit in contracts approval for a year and don’t know we have patients. Won’t move forward without validation. Some wait for sponsors to say they’ll pay you. Some just don’t. IT’s their obligation for ICH. Changing slowly.
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