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Non-inferiority tests for anti-infective drugs using control group quantiles
| Content Provider | Scilit |
|---|---|
| Author | Fay, Michael P. Follmann, Dean A. |
| Copyright Year | 2016 |
| Abstract | In testing for non-inferiority of anti-infective drugs, the primary endpoint is often the difference in the proportion of failures between the test and control group at a landmark time. The landmark time is chosen to approximately correspond to the qth historic quantile of the control group, and the non-inferiority margin is selected to be reasonable for the target level q. For designing these studies, a troubling issue is that the landmark time must be pre-specified, but there is no guarantee that the proportion of control failures at the landmark time will be close to the target level q. If the landmark time is far from the target control quantile, then the pre-specified non-inferiority margin may not longer be reasonable. Exact variable margin tests have been developed by Röhmel and Kieser to address this problem, but these tests can have poor power if the observed control failure rate at the landmark time is far from its historic value. We develop a new variable margin non-inferiority test where we continue sampling until a pre-specified proportion of failures, q, have occurred in the control group, where q is the target quantile level. The test does not require any assumptions on the failure time distributions, and hence, no knowledge of the true |
| Related Links | http://europepmc.org/articles/pmc5133167?pdf=render https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5133167/pdf |
| Ending Page | 640 |
| Page Count | 9 |
| Starting Page | 632 |
| ISSN | 17407745 |
| e-ISSN | 17407753 |
| DOI | 10.1177/1740774516654861 |
| Journal | Clinical Trials |
| Issue Number | 6 |
| Volume Number | 13 |
| Language | English |
| Publisher | SAGE Publications |
| Publisher Date | 2016-12-01 |
| Access Restriction | Open |
| Subject Keyword | Journal: Clinical Trials Difference in Proportions Non-inferiority Margin Variable Margin |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Pharmacology |
