In honor of World Obesity Day (celebrated on Oct. 11 2015) here is an American Heart Association Statistical Primer on Cardiovascular Research. Cardiovascular outcome trials (sometimes called CVOTs) are clinical trials that are critical for determining the safety of new anti-obesity and diabetes drugs. Early CVOTs like TECOS and SAVOR-TIMI enrolled over 14,000 and 16,000 patients respectively.
Cyrus Mehta, president and co-founder of Cytel, has been on the forefront of developing novel designs to shorten the length of these trials while maintaining high statistical rigor. In this primer he provides an overview of fixed sample, GS and adaptive designs for cardiovascular trials. Other topics include: adaptive sample size re-estimation, and SSR with enrichment for high and low risk subpopulations.
Statistical Primer for Cardiovascular Research
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