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Design and analysis of non-inferiority trials / Mark D. Rothmann, Brian L. Wiens, Ivan S.F. Chan.

By: Contributor(s): Material type: TextTextSeries: Chapman & Hall/CRC biostatistics seriesPublication details: Boca Raton, Fla. : Chapman & Hall/CRC, 2011.Description: xvi, 438 p. ; 25 cmISBN:
  • 9781584888048
Subject(s): LOC classification:
  • RM301.27 .R68 2011
Available additional physical forms:
  • Also available as an electronic resource.
Contents:
1. What is a non-inferiority trial? -- 2. Non-inferiority trial considerations -- 3. Strength of evidence and reproducibility -- 4. Evaluating the active control effect -- 5. Across-trials analysis methods -- 6. Three-arm non-inferiority trials -- 7. Multiple comparisons -- 8. Missing data and analysis sets -- 9. Safety studies -- 10. Additional topics -- 11. Inference on proportions -- 12. Inferences on means and medians -- 13. Inference on time-to-event endpoints.
Summary: "The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority trial. Using examples from real clinical trials, the book discusses general and regulatory issues and illustrates how they affect analysis. Each chapter begins with a non-technical introduction, so the subject is easily understood by those without prior knowledge of non-inferiority clinical trials. The book also provides detailed mathematical approaches along with their mathematical properties"--Provided by publisher.
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Holdings
Item type Current library Call number Status Date due Barcode Item holds
Books ISI Library, Kolkata NBHM Collection 615.580724 R846 (Browse shelf(Opens below)) Available 133206
Total holds: 0

"A Chapman & Hall book."

Includes bibliographical references and index.

1. What is a non-inferiority trial? -- 2. Non-inferiority trial considerations -- 3. Strength of evidence and reproducibility -- 4. Evaluating the active control effect -- 5. Across-trials analysis methods -- 6. Three-arm non-inferiority trials -- 7. Multiple comparisons -- 8. Missing data and analysis sets -- 9. Safety studies -- 10. Additional topics -- 11. Inference on proportions -- 12. Inferences on means and medians -- 13. Inference on time-to-event endpoints.

"The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority trial. Using examples from real clinical trials, the book discusses general and regulatory issues and illustrates how they affect analysis. Each chapter begins with a non-technical introduction, so the subject is easily understood by those without prior knowledge of non-inferiority clinical trials. The book also provides detailed mathematical approaches along with their mathematical properties"--Provided by publisher.

Also available as an electronic resource.

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