Clinical Drug Trials and Tribulations, Revised and Expanded

by Allen Cato, Lynda Sutton, Allen Cato III

Overview

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies.

Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management.

Bringing together the latest information on drug development, the Second Edition contains:

new material on…

international regulation and deregulation

venture capitalist investment

the IND process

informed consent

changes in manufacturing
and updated and extended coverage of…

pediatric drug trial design

the advantages and disadvantages of orphan drug designations

the maximization of package inserts for marketing

post approval safety surveillance

withdrawals from the drug market
Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Product Details

ISBN-13:	9780824703141
Publisher:	Taylor & Francis
Publication date:	03/26/2002
Series:	Drugs and the Pharmaceutical Sciences Series , #120
Edition description:	REV
Pages:	484
Product dimensions:	6.00(w) x 9.00(h) x (d)

About the Author

Allen Cato, Allen Sutton, Allen Cato III

Table of Contents

Current Challenges and Future Directions of Drug Development
Allen Cato, Lynda Sutton, and Allen Cato III
Preclinical Drug Discovery and Development
David S. Duch and Robert M. Ferris
The IND Process for New Drug Products
David M. Cocchetto
Performance and Interpretation of Laboratory Tests
W. Leigh Thompson, Rocco L. Brunelle, and Michael G. Wilson
Issues in Endpoint Selection
Karen D. Weiss and Jay Philip Siegel
Dix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 Days
W. Leigh Thompson
Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations
Allen Cato and Myron B. Peterson
Electronic Capture of Clinical Trial Information
Daniel C. Cato and David B. Thomas
Providing Patient Access to Promising Investigational Drugs
Peggy J. Berry and Allen Cato
Issues in the Review of Clinical Drug Trials by IRBs
Dale H. Cowan
Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts
Paul J. Reitemeier
Informed Consent in Clinical Trials: Emerging Issues
Cheryl K. Fiedler and H. Russell Searight
Orphan Drug Development: David and Goliath
Allen Cato, Susan L. Watts, Lynda Sutton, and Marlene E. Haffner
Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality
Nelson S. Irey
How to Deal with a Sudden, Unexpected Death in Clinical Studies
Allen Cato and Lynda Sutton
Clinical Trial Material-The Fuel for Clinical Research
David F. Bernstein
The Role of Pharmacokinetics in Drug Development
Allen Cato III and Richard Granneman
Building an NDA/BLA
Diana E. Fordyce and Angela Cahill
International Planning of Drug Clinical Trials
David L. Horwitz
Uncertainty in Drug Development: Approval Success Rates for New Drugs
Joseph A. DiMasi
Contract Clinical Research: Value to In-House Drug Development
F. Richard Nichol
Package Inserts as Viewed by the Busy Private Practitioner
Jean M. Findlay
New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances
Louis A. Morris and Peter H. Rheinstein
The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer
Todd S. Keiller
Anatomy of Drug Withdrawals in the United States
Marion J. Finkel
Appendices: Routine Clinical Analyte Test Results
Index

Editorial Reviews

Reviewer: Aryeh Hurwitz, M.D.(University of Kansas School of Medicine)
Description: This book provides an overview of clinical trials in drug development. Among topics discussed are trial design, ethical and regulatory matters, and practical issues in study implementation. The first edition was published in 1988.
Purpose: The authors purposely include some "how to" information, but try to focus on the "whys" behind decisions at the numerous steps in drug development. These are worthy objectives. Some of the 25 chapters try to cover so much material that they become too superficial to be useful. In some of these cases the references are not current enough to compensate for this defect. Other chapters are quite interesting and provocative. Generally the authors' objectives were met.
Audience: The authors intend this book to be read by neophytes in clinical drug development as well as by more experienced investigators. That's a pretty broad audience. Nevertheless, the book does succeed in providing useful and interesting material to its intended audience. It could be helpful for introducing beginners to clinical drug trials, although some missing topics, like recruitment of subjects, will necessitate reading of other sources. Based on their experience in drug trials the authors are qualified to write this book.
Features: This book includes chapters on regulatory issues, ethics, toxicity, and data management. Most of these chapters provide a reasonable overview and introduction, but are not really thorough enough to overcome the need for further reading by anyone interested in a specific topic. This limitation makes it essential to have current references for each chapter. Some of the chapters have essentially no references within the past five years, including the chapters on pharmacokinetics (including drug metabolism) and drug withdrawals — areas of much current interest.
Assessment: This book falls in the middle among the leading recent books on clinical drug trials. Of these, the most encyclopedic —and expensive — single volume monograph is Bert Spilker's Guide to Clinical Trials (Lippincott Williams & Wilkins, 1991). Fundamentals of Clinical Trials, 3rd edition, by Friedman et al. (Springer-Verlag, 1998) is the least expensive and provides a reasonable, statistically-based introduction and overview of clinical trial methodology. Clinical Trials: A Methodological Perspective by Piantadosi (John Wiley & Sons, 1997) is very heavily mathematical and theoretical, and is therefore not suitable for beginners. Fourteen years have elapsed between the first and second edition of this book. Although the references for some of the chapters are not as current as would be desirable, there is no question that much of the content of the new edition is updated.

Doody's Review Service

"
Praise for the first edition…

…serves well as a discussion of the clinical drug development process…will be of great value to anyone involved in regulatory affairs, clinical research, or pharmaceutical development.
"-Journal of Pharmaceutical Sciences

From the Publisher