Statistical Thinking for Non-Statisticians in Drug Regulation

Statistical methods are essential in the pharmaceutical industry for designing and analyzing clinical studies. This guide provides a comprehensive in-depth approach to statistical methodology for professionals working in the industry, including physicians, investigators, and regulatory personnel. It includes a detailed new chapter on Estimands and updated coverage of existing topics to reflect new guidance from regulatory authorities.

Format: Hardback
Length: 432 pages
Publication date: 29 December 2022
Publisher: John Wiley and Sons Ltd

Statistical methods play a crucial role in the pharmaceutical industry, as they are widely accepted as essential elements in the design and analysis of clinical studies. The medical and scientific community is increasingly aligning with regulatory authorities, recognizing the importance of using correct statistical methodologies to draw valid conclusions. To effectively employ these robust methods, effective communication across disciplines is necessary at all stages of planning, conducting, analyzing, and reporting clinical studies related to the development and evaluation of new drugs and devices.

Statistical Thinking for Non-Statisticians in Drug Regulation offers a comprehensive and detailed guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers, and those involved in pharmacovigilance. With the authors' extensive experience and up-to-date knowledge of pharmaceutical regulations and statistical practices within the broader clinical community, this book serves as an invaluable resource for those working within and alongside the industry.

The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation has been extensively revised and updated to reflect the latest developments in the field. It includes a comprehensive new chapter on Estimands, aligning with the 2019 Addendum to ICH E9. Other significant new sections cover topics such as Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis. The coverage has also been expanded to include updated information on m.

Weight: 900g
Dimension: 176 x 251 x 31 (mm)
ISBN-13: 9781119867388
Edition number: 3 ed