Practical considerations for estimating clinical trial accrual periods: application to a multi-center effectiveness study
| 作者： | Carter Rickey , Sonne Susan , Brady Kathleen |
| 刊名： | BMC Medical Research Methodology, 2005, Vol.5 (1), pp.11 |
| 来源数据库： | Directory of Open Access Journals |
| 原始语种摘要： | Abstract 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... |
