Predicting enrollment performance of investigational centers in phase III multi-center clinical trials.

ABSTRACT: Failure to meet subject recruitment targets in clinical trials continues to be a widespread problem with potentially serious scientific, logistical, financial and ethical consequences. On the operational level, enrollment-related issues may be mitigated by careful site selection and by allocating monitoring or training resources proportionally to the anticipated risk of poor enrollment. Such procedures require estimates of the expected recruitment performance that are sufficiently reliable to allow centers to be sensibly categorized. In this study, we investigate whether information obtained from feasibility questionnaires can potentially be used to predict which centers will and which centers will not meet their enrollment targets by means of multivariable logistic regression analysis. Fr

SUBMITTER: van den Bor RM 

PROVIDER: S-EPMC5898520 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature