TY - JOUR
T1 - Practical considerations for estimating clinical trial accrual periods
T2 - Application to a multi-center effectiveness study
AU - Carter, Rickey E.
AU - Sonne, Susan C.
AU - Brady, Kathleen T.
PY - 2005/3/30
Y1 - 2005/3/30
N2 - Background: Adequate participant recruitment is vital to the conduct of a clinical trial. Projected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated. Methods: This report illustrates three approaches to estimating the accrual period and applies the methods to a multi-center, randomized, placebo controlled trial undergoing development. Results: Incorporating known sources of accrual variation can yield a more justified estimate of the accrual period. Simulation studies can be incorporated into a clinical trial's planning phase to provide estimates for key accrual summaries including the mean and standard deviation of the accrual period. Conclusion: The accrual period of a clinical trial should be carefully considered, and the allocation of sufficient time for participant recruitment is a fundamental aspect of planning a clinical trial.
AB - Background: Adequate participant recruitment is vital to the conduct of a clinical trial. Projected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated. Methods: This report illustrates three approaches to estimating the accrual period and applies the methods to a multi-center, randomized, placebo controlled trial undergoing development. Results: Incorporating known sources of accrual variation can yield a more justified estimate of the accrual period. Simulation studies can be incorporated into a clinical trial's planning phase to provide estimates for key accrual summaries including the mean and standard deviation of the accrual period. Conclusion: The accrual period of a clinical trial should be carefully considered, and the allocation of sufficient time for participant recruitment is a fundamental aspect of planning a clinical trial.
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U2 - 10.1186/1471-2288-5-11
DO - 10.1186/1471-2288-5-11
M3 - Article
C2 - 15796782
AN - SCOPUS:17844381580
SN - 1471-2288
VL - 5
JO - BMC Medical Research Methodology
JF - BMC Medical Research Methodology
M1 - 11
ER -