One problem with the design is that about 20% of the women who are randomized to PMH will not comply (i.e., will go off PMH during the trial). In addition, 10% of the participants in the control group will go on PMH on their own during the study. How much power will the study have under these revised assumptions under the simplifying assumption that this lack of compliance occurs at the beginning of the study and 20,000 women are recruited for each treatment group?  

Cancer

The effect of using postmenopausal hormones (PMH) on health outcomes is controversial. Most previous data collected have been from observational studies, and users of PMH may selectively differ from nonusers in ways that are difficult to quantify (e.g., more health conscious, more physician visits in which disease outcomes can be identified). A clinical trial was planned to randomize postmenopausal women to either PMH use or no PMH use and follow them for disease outcomes over a 10-year period. One outcome of special interest was breast cancer.

Suppose the incidence rate of breast cancer among postmenopausal 50-year-old women who do not use PMH is 200 per 105 women per year. Suppose also it is hypothesized that PMH increases the incidence of breast cancer by 20%.