Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial.

ABSTRACT:

Background

The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited.

Methods

Four ancillary studies were add

SUBMITTER: Goodman PJ 

PROVIDER: S-EPMC4983010 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature