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Policy Forum Getting It Right: Being Smarter about Clinical Trials A major NIH meeting led to recommendations for conducting better clinical trials * Barnett S. Kramer , Joan Wilentz, Duane Alexander, John Burklow, Lawrence M. Friedman, Richard Hodes, Ruth Kirschstein, Amy Patterson, Griffi n Rodgers, Stephen E. Straus oncerns about adverse events, Recommendation 1: Be Aware progestin regimen [1,2]. In this case, including deaths, in recent large of and Eliminate Bias and conventional wisdom, based primarily clinical trials, both publicly and on observational studies, so strongly C Confounders, to the Extent privately sponsored, prompted Elias A. Possible supported the view that HRT would Zerhouni, Director, National Institutes lower (rather than increase) the risk of Health (NIH) to convene a meeting Among the most recent and notable of heart disease, stroke, and dementia at the NIH on January 11–12, 2005, to clinical trials that called prior in postmenopausal women, as well discuss “Moving from Observational observational evidence into question as prevent hip fracture, that critics was the NIH Women’s Health Initiative Studies to Clinical Trials: Why Do We protested that NIH was wasting money Sometimes Get It Wrong?” (a detailed clinical trial of combined estrogen