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| Content Provider | PubMed Central |
|---|---|
| Author | Sameer, Parpia Julian, Jim A. Gu, Chushu Thabane, Lehana Levine, Mark N. |
| Abstract | In trials with binary outcomes, assessed repeatedly at pre-specified times and where the subject is considered to have experienced a failure at the first occurrence of the outcome, interim analyses are performed, generally, after half or more of the subjects have completed follow-up. Depending on the duration of accrual relative to the length of follow-up, this may be inefficient, since there is a possibility that the trial will have completed accrual prior to the interim analysis. An alternative is to plan the interim analysis after subjects have completed follow-up to a time that is less than the fixed full follow-up duration. Using simulations, we evaluated three methods to estimate the event proportion for the interim analysis in terms of type I and II errors and the probability of early stopping. We considered: 1) estimation of the event proportion based on subjects who have been followed for a pre-specified time (less than the full follow-up duration) or who experienced the outcome; 2) estimation of the event proportion based on data from all subjects that have been randomized by the time of the interim analysis; and 3) the Kaplan-Meier approach to estimate the event proportion at the time of the interim analysis. Our results show that all methods preserve and have comparable type I and II errors in certain scenarios. In these cases, we recommend using the Kaplan-Meier method because it incorporates all the available data and has greater probability of early stopping when the treatment effect exists. |
| Related Links | http://dx.doi.org/10.1186/2193-1801-3-323 |
| Starting Page | 323 |
| File Format | |
| ISSN | 21931801 |
| e-ISSN | 21931801 |
| Journal | SpringerPlus |
| Volume Number | 3 |
| Language | English |
| Publisher | Springer International Publishing |
| Publisher Date | 2014-01-01 |
| Access Restriction | Open |
| Rights Holder | Springer International Publishing |
| Subject Keyword | Research in Higher Education |
| Content Type | Text |
| Resource Type | Article |
| Subject | Multidisciplinary |
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