Christopher Jennison

Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

In clinical trials, monitoring accumulating data at regular intervals is essential for balancing ethical and financial considerations against scientific rigor. This comprehensive second edition reflects the remarkable evolution in adaptive clinical trial methodology over the past two decades. Since publication of the first edition, these approaches have transformed from theoretical concepts to widely accepted practices, now endorsed by regulatory authorities, including formal FDA guidance.Features:Eleven entirely new chapters, including optimal design construction, delayed "pipeline" data accommodation, and multiple comparison proceduresEight dedicated chapters on adaptive methods including sample size re-assessment, seamless Phase II/III trials, multi-arm multi-stage trials, and enrichment designsExact methods for binary and Poisson data with applications to vaccine trialsExpanded discussion of binding versus non-binding futility boundaries for enhanced decision-makingA chapter with a thoroughly updated review of Bayesian approaches to sequential trial design and analysisIncorporates response-adaptive treatment assignment in group sequential designsPractical computational methods and software guidance for implementing the techniquesThis definitive resource serves statisticians, clinical researchers, pharmaceutical scientists, and regulatory professionals involved in clinical trial design and analysis. The text balances theoretical foundations with practical implementation guidance, making it invaluable for both experienced practitioners and those new to adaptive trial methodology. With twice the content of the first edition, this volume provides the comprehensive understanding needed to design more efficient, ethical, and scientifically rigorous clinical trials, ultimately accelerating the delivery of effective treatments to patients.

Was it Babe Ruth who said it best when he once remarked, “Baseball was, is, and always will be to me the best game in the world”? Or Mickey Mantle when he channeled Lou Gehrig during his 1969 farewell address: “I never knew how someone dying could say he was the luckiest man in the world. But now I understand”? Since the New York Highlanders became the New York Yankees in 1913, this dynamic franchise has captured the hearts and minds of fans across the nation. But for all the glory garnered by the men in pinstripes, their advice, wisdom, and passion has never been given a voice until now. Pinstripe Quotes is a unique collection of quotes, stories, and historic anecdotes as spoken by the players themselves, and the men and women who knew them best. Where else will fans learn Lou Gehrig’s thoughts on racial discrimination, or Derek Jeter’s penchant for singing out loud when no one else is around? What Yankees fan won’t relish reliving the team’s first World Series victory through the eyes of the sportswriters and cheering crowds who were there? A franchise with over a century of triumph, tragedy, and unflinching determination, the players of the New York Yankees have the sayings and words of wisdom that will carry fans through anything—from a rough day at work, to the best way to celebrate a World Series victory. Without a doubt, Pinstripe Quotes is a must-have for any fan.

Renowned artist Andy Jurinko believed the golden age of baseball was 1946-1960, an era that, not coincidentally, coincided with his childhood. It was a time that welcomed such legendary stars as Willie Mays, Mickey Mantle, Jackie Robinson, Ted Williams, and Henry Aaron into the national consciousness, a fifteen year stretch marked by Robinson’s breaking of the color barrier in 1947 and by ten Yankee championships. Jurinko spent twenty years creating more than 600 portraits of the colorful characters and stadiums that typify this era, all collected here for the first time in Golden Boys. With illuminating text by sportswriter Christopher Jennison, Golden Boys is the definitive artistic portrait of a remarkable time in American sports history.