Does clustering affect the usual test statistics of no treatment effect in a randomized clinical trial? (English) Zbl 0903.62091

Parzen, Michael; Lipsitz, Stuart R.; Dear, Keith B. G.

Biom. J. 40, No. 4, 385-402 (1998).

Summary: In many clinical trials, such as those undertaken by large cooperative cancer groups (CALGB, ECOG, SWOG, EORTC), patients are randomized to one of two treatments within an institution (a hospital or clinic). In such clinical trials, it has often occurred that outcomes of patients within institutions tend to be similar (correlated), due, possibly, to unmeasured variables such as quality of staff or quality of hospital equipment. We discuss when, in the presence of random hospital effects, the usual test statistics for no treatment effect, which do not take these hospital effects into account, are (asymptotically) unbiased.

MSC:

62P10

Applications of statistics to biology and medical sciences; meta analysis

Keywords:

binary data; regression; two-sample t-test; clinical trials