Case Studies In Accrual Prediction

Currently, accrual is estimated by the principal investigator. Investigators are optimistic regarding accrual estimates, with studies citing their over-estimation of accrual at between two- and six-times actual.(5, 7) Often times, this estimate is not based on empirical evidence, but a “gut feel” or the response that the investigator knows the decision makers want to hear. However, this metric is still important to obtain as part of the feasibility review, as planning for maximum needed resources can be assessed.

While a prediction of accrual (whether obtained by the investigator or a model) should not be used as the sole-determining factor of activating a study, it can be utilized with other feasibility information to make an informed decision on whether to activate a study. With decreasing federal funding to support clinical trials and a growing number of clinical trial opportunities, organizations must make wise decisions on what to activate in order to maintain solvency in clinical trial operations. Providing standardized, objective data regarding the likelihood of accrual success can help delegate staff resources, negotiate budgets, and plan the activation pipeline for a clinical trials office while decreasing the number of unplanned, low-accruing studies. In theory, this should increase the productivity of the clinical trials office.