Design and analysis of non-inferiority trials
Rothmann, Mark D.
Design and analysis of non-inferiority trials [electronic resource] / Mark D. Rothmann, Brian L. Wiens, Ivan S.F. Chan. - Boca Raton, Fla. : Chapman & Hall/CRC, 2011. - xvi, 438 p. - Chapman & Hall/CRC biostatistics series . - Chapman & Hall/CRC biostatistics series. .
"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.
Mode of access: World Wide Web.
9781584888055 (ebook : PDF)
Drugs--Testing.
Experimental design.
Therapeutics, Experimental.
Electronic books.
Design and analysis of non-inferiority trials [electronic resource] / Mark D. Rothmann, Brian L. Wiens, Ivan S.F. Chan. - Boca Raton, Fla. : Chapman & Hall/CRC, 2011. - xvi, 438 p. - Chapman & Hall/CRC biostatistics series . - Chapman & Hall/CRC biostatistics series. .
"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.
Mode of access: World Wide Web.
9781584888055 (ebook : PDF)
Drugs--Testing.
Experimental design.
Therapeutics, Experimental.
Electronic books.