Statistical Thinking for Non-Statisticians in Drug Regulation
1st Edition
Published on 7. September 2007
Book
Hardback
296 pages
978-0-470-31971-0 (ISBN)
Description
Within the complex processes of planning, and conducting, analysing and reporting clinical trials in the pharmaceutical industry, the interaction between the statistician and non-statistician is not always a successful one. There is often of confusion on the part of the non-specialist in understanding specific statistical terms and those that appear the same or similar which can make operating within a regulatory environment difficult.
This book presents the statistical methods employed by the pharmaceutical industry in relation to current regulatory requirements and explains them in ways that are easily understandable by providing an insight into their interpretation and context in which they are used. The book does not aim to turn non-statisticians into statisticians but aims to:
* aid communication between statisticians and non-statisticians
* help in the critical review of reports and publications and
* enable the more effective use of statistical arguments within the regulatory process.
Those working within the pharmaceutical industry: physicians, investigators, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in quality assurance will find this book a valuable learning tool on statistics; a key aspect of being familiar with the rules and regulations that govern their use and interpretation.
Reviews / Votes
"This book is a useful addition to the non-statisticians armoury and should be noted." (Journal of Mental Health, February 2009) "The information throughout this book is immediately useful ... this book should be very useful for anyone involved in the design, analysis, and judgment of clinical trial data." (Drug Information Journal, 2008)More details
Edition
1., Auflage
Language
English
Place of publication
Hoboken
United Kingdom
Publishing group
John Wiley and Sons Ltd
Target group
Professional and scholarly
Illustrations
Illustrations
Dimensions
Height: 24.4 cm
Width: 16.8 cm
Thickness: 21 mm
Weight
656 gr
ISBN-13
978-0-470-31971-0 (9780470319710)
Schweitzer Classification
Other editions
New editions
Book
10/2014
2nd Edition
Wiley
Unfortunately, price unknown
Article exhausted; check for reprint
Person
Richard Kay. PhD Medical Statistics. The author worked within academia until 1989 when he set up his own company offering statistics and data management services to the pharmaceutical industry. Since 2005, he works as an Independent Statistical Consultant providing full consultancy and training course service to the Pharmaceutical and Medical Device industries. The author currently lectures and runs courses for the pharmaceutical industry in all major European countries: UK, France, Ireland, Belgium, The Netherlands, Germany, Spain, Italy, Switzerland, Sweden, Denmark, Russia and South Africa and US. His lectures are predominantly given within Pharma Cos or CROs.
Content
1 Basic ideas in clinical trial design
2 Sampling and inferential statistics
3 Confidence intervals and p-values
4 Tests for simple treatment comparisons
5 Multi-centre trials
6 Adjusted analyses and analysis of covariance
*6.3 Multiple regression
*6.5.3 A single model
*6.8 Connection between ANOVA and ANCOVA
7 Intention-to-treat and analysis sets
8 Power and sample size
9 Statistical significance and clinical importance
10 Multiple testing
11 Non-parametric and related methods
12 Equivalence and non-inferiority
13 The analysis of survival data
*13.4.5 Calculating KM curves
*13. 5 Adjusted analyses
14 Interim analysis and data monitoring committees
15 Meta-analysis
16 The role of statistics and statisticians
04705106683ENTable of contents
Introduction
Chapter 1 What are innovation, creativity and design?
Chapter 2 Innovation = creativity & commercialisation Case Study 1 BBC's 'Walking with dinosaurs'
Appendix 1 Meet the Dinosaurs
Appendix 2 Stages of the Animation Process
Appendix 3 Excerpt from Brand Guide
Appendix 4 Awards as of 30th October 2001
Chapter 3 Structured processes for developing new products
Chapter 4 A note on globalisation
Chapter 5 Innovation & branding for the web Case Study 2 ihavemoved.com - A Appendix 1 Background to the 4 founders
Chapter 6 Strategy - emergent or planned, and other issues
Chapter 7 Branding and Innovation
Chapter 8 The value of market research
Case study 3 Black & Decker's Quattro
Appendix 1 Company History
Appendix 2 Capital Appropriation Request, Summary Extracts
Chapter 9 Approaches to Market Research
Chapter 10 A note on teams
Chapter 11 Collaboration - innovation in manufacturing
Case Study 4 The Lotus Elise
Chapter 12 The role of prototypes
Chapter 13 Collaborating for innovation
Chapter 14 Innovation & industry context
Case Study 5 Roche - Saquinavir
Appendix 1 Team members
Appendix 2 Drug Discovery Value Chain
Chapter 15 The effects of industry and cultural context
Chapter 16 Informal networks and the management of knowledge
Chapter 17 Innovation for the environment
Case Study 6 Plastwood by Dumfries Recycling
Appendix 1 Alternatives to Recycling
Appendix 2 Recycling at BPI
Chapter 18 Green design - clean environment or clean conscious?
Chapter 19 Note on Intellectual Property Rights (IPR)
Chapter 20 Innovation in large organisations