By Richard Kay

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION

Statistical methods play a crucial role in the design and analysis of clinical studies in the pharmaceutical industry. The medical and scientific community is increasingly recognizing the importance of correct statistical methodology, aligning with regulatory authorities to ensure valid conclusions are drawn. Effective communication across disciplines is essential throughout the development and evaluation of new drugs and devices, from planning to reporting. In his book, “Statistical Thinking for Non-Statisticians in Drug Regulation,” Richard Kay offers a comprehensive guide to statistical methodology for professionals in the pharmaceutical industry and related fields.

Kay’s extensive experience and up-to-date familiarity with pharmaceutical regulations and statistical practices make this book an essential resource for those working in and with the industry. The third edition of “Statistical Thinking for Non-Statisticians in Drug Regulation” features new and revised content to reflect the latest developments in the field.

One notable addition is a detailed new chapter on Estimands, aligning with the 2019 Addendum to ICH E9. Estimands are an important concept in clinical trials, representing the treatment effect that is of interest to stakeholders. Understanding and properly defining estimands is crucial for ensuring the validity and interpretability of clinical trial results.

The third edition also includes major new sections on various 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. These additions reflect the evolving landscape of drug regulation and the need for statisticians and non-statisticians alike to stay updated on the latest methodologies and practices.

In addition to the new content, the book also covers existing topics that have been updated to reflect new and revised guidance from regulatory authorities and the author’s own experience. This ensures that readers have access to the most current and relevant information available.

Overall, “Statistical Thinking for Non-Statisticians in Drug Regulation” is a valuable resource for professionals in the pharmaceutical and medical device industry, as well as statisticians entering the field and students and teachers of drug development. The book provides a comprehensive and in-depth exploration of statistical methodology, enabling readers to navigate the complex landscape of drug regulation with confidence.

Ordering the book provides access to a wealth of knowledge and insights that can greatly enhance one’s understanding of statistical thinking in drug regulation. Whether you are a physician, investigator, medical science liaison, clinical research scientist, medical writer, regulatory personnel, statistical programmer, senior data manager, or working in pharmacovigilance, this book is an indispensable tool for advancing your career and achieving success in the pharmaceutical industry.

Discover the power of statistical thinking and its impact on drug regulation. Order your copy of “Statistical Thinking for Non-Statisticians in Drug Regulation” today and unlock a world of valuable insights and expertise.

Product Details

• Publisher: Wiley-Blackwell; 3rd edition (December 13, 2022)
• Language: English
• eBook Digital: 432 pages
• ISBN-10: 111986738X
• ISBN-13: 978-1119867388