Sample size and power determination when limited preliminary information is available.

ABSTRACT:

Background

We describe a novel strategy for power and sample size determination developed for studies utilizing investigational technologies with limited available preliminary data, specifically of imaging biomarkers. We evaluated diffuse optical spectroscopic imaging (DOSI), an experimental noninvasive imaging technique that may be capable of assessing changes in mammographic density. Because there is significant evidence that tamoxifen treatment is more effective at reducing breast cancer risk when accompanied by a reduction of breast density, we designed a study to assess the changes from baseline in DOSI imaging biomarkers that may reflect fluctuations in breast density in premenopausal women receiving tamoxifen.

Method

While preliminary data demonstrate that DOSI is sen

SUBMITTER: McLaren CE 

PROVIDER: S-EPMC5406943 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature