Assessing allocation bias in stratified clinical trials with multi-component endpoints evaluated using the stratified Wei-Lachin test
Allocation bias threatens the validity of stratified clinical trials with multi-component endpoints evaluated using the stratified Wei-Lachin test and should be mitigated through careful study planning. Ensure the number of patients in each stratum is not smaller than the number of strata, restrict the number of endpoint components to those essential for the study's objectives, and use randomization procedures that allow for some imbalances, such as the Big Stick Design, to reduce allocation predictability.
Authors
- N Heussen (ORCID: https://orcid.org/0000-0002-6134-7206)
- Stefanie Schoenen
- Ralf-Dieter Hilgers
Institutions
- Sigmund Freud Privatuniversität Wien (AT)
- RWTH Aachen University (DE)
Publication Details
- Journal
- PLoS ONE
- Published
- 2026-02-13
- DOI
- https://doi.org/10.1371/journal.pone.0341039
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00