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Clinical Trials in Late Life: New Science in Old Paradigms

Correspondence: Address correspondence to Barry D. Lebowitz, PhD, National Institute of Mental Health, 6001 Executive Blvd., Rm. 7160, MSC 9635, Bethesda, MD 20892. E-mail: blebowit{at}mail.nih.gov

This article, based on a Lawton Award Lecture, addresses the subject of the need to enhance the evidence base in our field in order to influence processes of policy development. Four issues are identified as critical to this: theory-driven targets of public health significance, use of appropriate and sophisticated approaches to research design and statistical modeling, development of instruments and measures, and conclusions that make a difference. Incentives are discussed with particular attention to regulatory approaches. A broad view of research is taken, with examples from studies of Alzheimer's disease and depression in late life. I conclude that new approaches to methodology will enhance our capacity to translate exciting new findings from the basic sciences into the development of therapeutics and that this will, in turn, enhance our capacity to inform the development of public policy.

Key Words: Clinical trials • Alzheimer's disease • Depression • Methodology

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