Observational studies, clinical trials, and the women's health initiative.
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.
Prentice
Ross L
RL
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, Seattle, WA 98109, USA. rprentic@fhcrc.org
D000368:Aged; D001943:Breast Neoplasms / Q000517:prevention & control*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D018752:Diet, Fat-Restricted; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016387:Women's Health