Description of Collaborative Activity: |
A workgroup was formed under the auspices of the American College of Neuropsychopharmacology, known as the ACTIVE (Alcohol Clinical Trials Initiative) and consists of academic experts, industry representatives, and staff from the Food and Drug Administration, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse. The purpose is to explore methodological issues of conducting alcohol clinical trials and to provide the Food and Drug Administration (FDA), pharma, and the academic community evidence-based analyses into aspects of alcohol clinical trials such as endpoints, durations of trials, the placebo effect, handling of missing data, and grace periods. ACTIVE provides analyses for the FDA to use in developing evidence-based guidelines. |
Type of Collaborative Activity: |
Committee, Advisory Group, or Work Group
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