The questionable use of unequal allocation in confirmatory trials
Identifieur interne : 000894 ( Main/Exploration ); précédent : 000893; suivant : 000895The questionable use of unequal allocation in confirmatory trials
Auteurs : Spencer Phillips Hey ; Jonathan KimmelmanSource :
- Neurology [ 0028-3878 ] ; 2014.
Abstract
Randomization is the standard means for addressing known and unknown confounders within the patient population in clinical trials. Although random assignment to treatment arms on a 1:1 basis has long been the norm, many 2-armed confirmatory trials now use unequal allocation schemes where the number of patients receiving investigational interventions exceeds those in the comparator arm. In what follows, we offer 3 arguments for why investigators, institutional review boards, and data and safety monitoring boards should exercise caution when planning or reviewing 2-armed confirmatory trials involving unequal allocation ratios. We close by laying out some of the conditions where uneven allocation can be justified ethically.
Url:
DOI: 10.1212/01.wnl.0000438226.10353.1c
PubMed: 24306005
PubMed Central: 3873626
Affiliations:
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