Lifetime Data Analysis

, Volume 13, Issue 4, pp 449–462

Observational studies, clinical trials, and the women’s health initiative


DOI: 10.1007/s10985-007-9047-z

Cite this article as:
Prentice, R.L. Lifetime Data Anal (2007) 13: 449. doi:10.1007/s10985-007-9047-z


The complementary roles fulfilled by observational studies and randomized controlled trials in the population science research agenda is illustrated using results from the Women’s Health Initiative (WHI). Comparative and joint analyses of clinical trial and observational study data can enhance observational study design and analysis choices, and can augment randomized trial implications. These concepts are described in the context of findings from the WHI randomized trials of postmenopausal hormone therapy and of a low-fat dietary pattern, especially in relation to coronary heart disease, stroke, and breast cancer. The role of biomarkers of exposure and outcome, including high-dimensional genomic and proteomic biomarkers, in the elucidation of disease associations, will also be discussed in these same contexts.


BiomarkerCohort studyDietGenomicsHormonesProteomicsRandomized controlled trial

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  1. 1.Division of Public Health SciencesFred Hutchinson Cancer Research CenterSeattleUSA