Monitoring the quality of conduct of clinical trials: a survey of current practices.

Background: There is a little empirical evidence to determine which, if any, monitoring practices best achieve the goals of trial monitoring set forth in ICH E6 under the variable circumstances of different clinical trial settings.

Purpose: The purpose of this project was to describe current methods of monitoring clinical trials and to explore the rationale for the use of those methods.

Methods: An electronic survey of known monitoring practices was developed and sent to over 200 organizations involved in conducting clinical research.

Serum leptin levels, hormone levels, and hot flashes in midlife women.

Objective: To examine the associations between serum leptin levels, sex steroid hormone levels, and hot flashes in normal weight and obese midlife women.

Design: Cross-sectional study.

Setting: University clinic.

Cigarette smoking, androgen levels, and hot flushes in midlife women.

Objective: To test the hypothesis that cigarette smoking is associated with hot flushes through a mechanism involving androgen levels, progesterone levels, sex hormone-binding globulin levels, or the ratio of androgens to estrogens.

Methods: Women with and without hot flushes were recruited from Baltimore, Maryland, and the surrounding counties. Women were between 45 and 54 years of age, with at least three menstrual periods in the previous 12 months, and were not postmenopausal.