Power and sample size considerations in clinical trials with competing risk endpoints
| Autor: | Ellen Maki |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Risk
Pharmacology Statistics and Probability Research design Clinical Trials as Topic Endpoint Determination Accrual Computer science Competing risks Clinical trial Research Design Sample size determination Data Interpretation Statistical Sample Size Econometrics Humans Pharmacology (medical) Parametric statistics Event (probability theory) |
| Zdroj: | Pharmaceutical Statistics. 5:159-171 |
| ISSN: | 1539-1612 1539-1604 |
| DOI: | 10.1002/pst.200 |
| Popis: | In clinical trials with a time-to-event endpoint, subjects are often at risk for events other than the one of interest. When the occurrence of one type of event precludes observation of any later events or alters the probably of subsequent events, the situation is one of competing risks. During the planning stage of a clinical trial with competing risks, it is important to take all possible events into account. This paper gives expressions for the power and sample size for competing risks based on a flexible parametric Weibull model. Nonuniform accrual to the study is considered and an allocation ratio other than one may be used. Results are also provided for the case where two or more of the competing risks are of primary interest. |
| Databáze: | OpenAIRE |
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