Clinical and statistical assessment of suicidal ideation and behavior in pharmaceutical trials.

In the past two decades, the potential association between the risk of suicidal ideation and behavior and the clinical use of pharmaceutical products has been debated among industry, regulators, and academia. A better understanding of the possible effects-favorable, unfavorable, or neutral-of pharmaceuticals on the risk of suicidal ideation and behavior may be required, especially for trials typically designed for other primary objectives. Here, a cross-industry statistical team provides recommendations that address the assessment, statistical analysis, interpretation, and utility of suicide-related data in pharmaceutical clinical trials. These recommendations are to evaluate suicidal ideation, suicidal behavior, and the two combined as end points; utilize standard scales to collect data prospectively; and analyze the data using several statistical methods. A more accurate assessment of the potential association between the use of pharmaceutical products and risk of suicide-related events will contribute to estimating the benefit/risk ratio and result in safer medicines for patients.

Rates of weight change for black and white Americans over a twenty year period.

OBJECTIVE: To examine the rate of weight gain over time among Americans by age, gender, and race. PARTICIPANTS: Scientific sample of 5117 Americans, ages 25-74 y in 1971 followed for 20 y. RESULTS: Rates of weight gain estimated by mixed effects models are highest among young adults and rates of weight loss are greatest among older adults. The overall shape of the growth curves are similar for men and women, black and white, in terms of both weight gain and weight loss. Rates are also affected by baseline body mass index (BMI=wt in kg/height in m(2)). CONCLUSIONS: Americans gain weight until middle age, stabilize, and begin to lose weight near age 60. Weight loss during old age is especially evident for obese Americans. The ability to accurately identify groups with increased risk and target them for obesity prevention will help combat the steady rise of overweight and obesity in America.