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Quantitative Decisions in Drug Development: Springer Series in Pharmaceutical Statistics

Autor Christy Chuang-Stein, Simon Kirby
en Limba Engleză Paperback – 5 sep 2022
This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition.
The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria tothe cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors.
The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm.
The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.
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Specificații

ISBN-13: 9783030797331
ISBN-10: 3030797333
Pagini: 342
Ilustrații: XIX, 342 p. 86 illus., 21 illus. in color.
Dimensiuni: 155 x 235 mm
Greutate: 0.51 kg
Ediția:2nd ed. 2021
Editura: Springer International Publishing
Colecția Springer
Seria Springer Series in Pharmaceutical Statistics

Locul publicării:Cham, Switzerland

Cuprins

Chapter 1 - Clinical Testing of a New Drug.- Chapter 2 - A Frequentist Decision-making Framework.- Chapter 3 - Characteristics of a Diagnostic Test.- Chapter 4 - The Parallel Between Clinical Trials and Diagnostic Tests.- Chapter 5 - Incorporating Information from Completed Trials in Future Trial Planning.- Chapter 6 - Choosing Metrics Appropriate for Different Stages of Drug Development.- Chapter 7 - Designing Proof-of-Concept Trials with Desired Characteristics.- Chapter 8 - Designing Dose-response Studies with Desired Characteristics.- Chapter 9 - Designing Confirmatory Trials with Desired Characteristics.- Chapter 10 - Designing Phase 4 Trials.- Chapter 11 - Other Metrics That Have Been Proposed to Optimize Drug Development Decisions.- Chapter 12 - Discounting Prior Results to Account for Selection Bias.- Chapter 13 - Adaptive Designs.- Chapter 14 - Additional Topics.

Notă biografică

Christy Chuang-Stein received a bachelor degree in mathematics from the National Taiwan University and a PhD in statistics from the University of Minnesota. She retired from Pfizer as Vice President and Head of the Statistical Research and Consulting Center in July 2015, after 30 years in the pharmaceutical industry and 5 years in academia (University of Rochester). Currently, Christy is the owner and Principal Consultant of Chuang-Stein Consulting, LLC and consults broadly in the areas of pharmaceutical development and evaluation. 
Christy is a Fellow of the American Statistical Association (ASA) and received the ASA’s Founders’ Award in 2012. She was the recipient of the Distinguished Achievement Award of the International Chinese Statistical Association in 2013 and the Distinguished Service Award from the National Institute of Statistical Sciences in 2020. She is also a repeat recipient of the Drug Information Association’s Donald Francke Award for Excellence in Journal Publishing and the Thomas Teal Award for Excellence in Statistics Publishing. Christy is a founding editor of the journal Pharmaceutical Statistics.
Simon Kirby received a BSc In Economics and Economic Policy from Loughborough University, an MSc in Statistics from the University of Kent, a PhD in Statistics from the University of Edinburgh and a BA in Mathematics from the Open University. He retired from Pfizer in 2018 after almost 20 years working as a Principal Statistician, Clinical Statistics Head, Therapeutic Area Statistics Head and Consultant in the Statistical Research and Consulting Center. He is the owner of SKSTATS Limited for which he does occasional statistical consultancy.
Simon is a Fellow and Chartered Statistician of the Royal Statistical Society. He previously worked as a Lecturer, Senior Lecturer then Principal Lecturer in Statistics at Liverpool John Moores University and as a Statistician at the U.K.’s Institute of Food Research,Rothamsted Experimental Station and Revlon Healthcare. 

Textul de pe ultima copertă

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition.
The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria tothe cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors.
The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm.
The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.


Caracteristici

Focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug Takes a holistic approach towards drug development by incorporating knowledge learned from the earlier part of the development explicitly into the decisions at later stages Shows the parallel between clinical trials and diagnostic tests and how this analogy is used to emphasize the importance of replication in drug development Describes how to incorporate prior knowledge into study design and decision making at different stages of drug development Explains metrics useful to address the objectives of the different stages of drug development and how to compare design options based on these metrics Demonstrates why over-estimation is a common problem in drug development and how adjustment should be considered to correct the over-estimation

Recenzii

“This work offers useful algorithms, classifications, and other general points to statisticians or ‘quantitative scientists’. But, it is also really useful to regulatory affairs managers, clinicians, medical writers, and all kinds of decision-makers in the industry.” (Andrei Myslivets, ISCB News, Vol. 68, December, 2019)

“It is presented in a concise, structured, friendly, and illustrative way that allows for a good understanding of the underlying ideas … . the book from Chuang-Stein and Kirby is a valuable, interesting and easy read for statisticians and clinicians with some methodological background who are involved in clinical development or drug approval and who are looking for a structured way to make clinical development decisions.” (Norbert Benda, Biometrical Journal, Vol. 61 (4), July, 2016)