Abstract
Abstract Early developments in controlled clinical trials at the National Institutes of Health (NIH) took place mainly at the National Cancer Institute (NCI) and what was then the National Heart Institute (NHI) (subsequently the National Heart, Lung, and Blood Institute (NHLBI))beginning in the 1950s. This article reviews the developments from the early 1950s to the late 1960s at both institutes, summarizing the early efforts in clinical trials, the organizations set up to conduct and monitor the clinical trials, and the developments in statistical methodology that have formed the basis for conducting many of the present day randomized controlled trials. The early history of clinical trials at these institutes has been reviewed in more detail at NCI by Gehan & Schneiderman and at NHLBI by Halperin et al.
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