Statistical monitoring of clinical trials : a unified approach
The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows t...
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| Glavni autori: | , , , |
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| Format: | Livre numérique |
| Jezik: | Anglais |
| Izdano: |
New York, NY :
Springer New York
[20..].
Cham : Springer Nature |
| Izdanje: | 1st ed. 2006. |
| Serija: | Statistics for biology and health
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| Teme: | |
| Online pristup: | Accès sur la plateforme de l'éditeur Accès sur la plateforme Istex Accès Université d'Orléans Accès INSA CVL |
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Description d'après consultation du 26 avril 2011 Archives Springer e-books (Licence nationale) Archives Springer e-books (Licence nationale) |
| Autres localisations: | Voir dans le Sudoc |
| Edition sous un autre format: | • Statistical monitoring of clinical trials, a unified approach, Michael A. Proschan, K.K. Gordon Lan, Janet Turk Wittes, 2006, New York, Springer, 1 vol. (XIII-258 p.), Statistics for biology and health, 0-387-30059-7 |
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| 100 | 1 | |a Proschan, Michael A., |d 19..-...., |c statisticien. | |
| 245 | 1 | 0 | |a Statistical monitoring of clinical trials : |b a unified approach |c Michael A. Proschan, K. K. Gordon Lan, Janet Turk Wittes. |
| 250 | |a 1st ed. 2006. | ||
| 260 | |a New York, NY : |b Springer New York. | ||
| 260 | |a Cham : |b Springer Nature, |c [20..]. | ||
| 490 | 0 | |a Statistics for biology and health |x 1431-8776 | |
| 500 | |a Description d'après consultation du 26 avril 2011 | ||
| 500 | |a Archives Springer e-books (Licence nationale) | ||
| 500 | |a Archives Springer e-books (Licence nationale) | ||
| 504 | |a Bibliogr. p. [247]-254. Index | ||
| 505 | 1 | |a A General Framework Power: Conditional, Unconditional, and Predictive Historical Monitoring Boundaries Spending Functions Practical Survival Monitoring Inference Following a Group-Sequential Trial Options When Brownian Motion Does Not Hold Monitoring for Safety Bayesian Monitoring Adaptive Sample Size Methods Topics Not Covered Appendix I: The Logrank and Related Tests Appendix II: Group-Sequential Software | |
| 506 | |a Accès en ligne pour les établissements français bénéficiaires des licences nationales | ||
| 506 | |a Accès soumis à abonnement pour tout autre établissement | ||
| 506 | |a Conditions particulières de réutilisation pour les bénéficiaires des licences nationales. https://www.licencesnationales.fr/springer-nature-ebooks-contrat-licence-ln-2017 | ||
| 520 | |a The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion (``the B-value") irrespective of the test statistic. The so-called B-value approach to monitoring allows us to use, for different types of trials, the same boundaries and the same simple formula for computing conditional power. Although Brownian motion may sound complicated, the authors make the approach easy by starting with a simple example and building on it, one piece at a time, ultimately showing that Brownian motion works for many different types of clinical trials. The book will be very valuable to statisticians involved in clinical trials. The main body of the chapters is accessible to anyone with knowledge of a standard mathematical statistics text. More mathematically advanced readers will find rigorous developments in appendices at the end of chapters. Reading the book will develop insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials. Michael Proschan, Gordon Lan, and Janet Wittes are elected Fellows of the American Statistical Association. All have spent formative years in the Biostatistics Research Branch of the National Heart, Lung, and Blood Institute (NHLBI/NIH). While there, they were intimately involved in the design and statistical monitoring of large-scale randomized clinical trials, developing methodology to aid in their monitoring. For example, Lan developed, with DeMets, the now widely-used spending function approach to group sequential designs, whose properties were further investigated by Proschan. The B-value approach used in the book was introduced in a very influential paper by Lan and Wittes. The statistical theory behind conditional power was developed by Lan, along with Simon and Halperin, and was the cornerstone for the conditional error approach to adaptive clinical trials introduced by Proschan and Hunsberger. All three authors have expertise in adaptive methodology for clinical trials. Michael Proschan is a Mathematical Statistician at the National Institutes of Health; Gordon Lan is Senior Director of Biometrics at Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Janet Wittes is President of Statistics Collaborative, a statistical consulting company she founded in 1990 | ||
| 650 | |a Études cliniques |x Méthodes statistiques | ||
| 700 | 1 | |a Lan, K. K. Gordon. |4 aut | |
| 700 | 1 | |a Wittes, Janet Turk. |4 aut | |
| 700 | 1 | |a Lan, K K Gordan. |4 aut | |
| 700 | 1 | |a Wittes, Janet Turk. |4 aut | |
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