Abstract
BackgroundAdequate 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.MethodsThis report illustrates three approaches to estimating the accrual period and applies the methods to a multi-center, randomized, placebo controlled trial undergoing development.ResultsIncorporating 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.ConclusionThe 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.
Highlights
IntroductionProjected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated
Adequate participant recruitment is vital to the conduct of a clinical trial
Clinical trials often plan to enroll hundreds to thousands of human subjects, and careful and regulated planning is employed to ensure that the trial's scientific objectives are fulfilled
Summary
Projected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated. The importance of the feasibility and timeliness of participant accrual is often minimized during the planning stage. This is unfortunate since the recruitment of human subjects into a clinical trial must be timely and is vital to the success of the trial [1,2]. A clinical trial must be planned with an adequate understanding of the potential accrual rate so that the clinical trial's scientific objectives can be evaluated in a timely manner.
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