Design and Analysis of Non-Inferiority Trials

di Mark D. Rothmann (Autore)

Brian L. Wiens (Autore)

Ivan S.F. Chan (Autore)

Taylor & Francis Ltd, 2020

The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, 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. Each chapter begins with a non-technical introduction, making the text easily understood by those without prior knowledge of this type of trial. Topics covered include: A variety of issues of non-inferiority trials, including multiple comparisons, missing data, analysis population, the use of safety margins, the internal consistency of non-inferiority inference, the use of surrogate endpoints, trial monitoring, and equivalence trials Specific issues and analysis methods when the data are binary, continuous, and time-to-event The history of non-inferiority trials and the design and conduct considerations for a non-inferiority trial The strength of evidence of an efficacy finding and how to evaluate the effect size of an active control therapy A comprehensive discussion on the purpose and issues involved with non-inferiority trials, Design and Analysis of Non-inferiority Trials will assist current and future scientists and statisticians on the optimal design of non-inferiority trials and in assessing the quality of non-inferiority comparisons done in practice.

• Autore: Mark D. Rothmann, Brian L. Wiens, Ivan S.F. Chan
• Editore: Taylor & Francis Ltd
• Collana: Chapman & Hall/CRC Biostatistics Series
• Anno: 2020
• Rilegatura: Paperback / softback
• Pagine: 454 p.
• Dimensioni: 234 x 156 mm
• Peso: 707 gr.
• EAN: 9780367576912

Testo in English