Fundamentals of Clinical Trials [Paperback]

Lawrence M. Friedman (Author), Curt D. Furberg (Author), David L. DeMets (Author)

Book Description

Publication Date: December 1999 | ISBN-10: 0387985867 | ISBN-13: 978-0387985862 | Edition: 3rd

The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and diagnostic tests. This trial design has been successfully used in both therapeutic and disease prevention trials. It is superior to alternative designs by eliminating several sources of bias which exist in those designs. This role has evolved over the past three decades in a number of disease areas including cardiology, opthalmology, cancer and AIDS. While the specifics of using the randomized control design for a specific intervention and disease may differ, the basic fundamentals still apply in developing the study protocol and operational procedures. These fundamentals still apply in developing the study protocol and operational procedures. These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure. This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women's health and screening tests. In these studies, the authors have served as members of the steering committee responsible for developing the protocol and as members of data and safety monitoring committees. The fundamentals were proposed in the first edition published in 1981 and have not changed substantially in the later editions. However, the number of examples illustrating the fundamentals has greatly expanded base on the collective experience of the authors. This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The test uses numerous examples of published clinical trials from a variety of medical disciples to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity. The text assumes that the readers have only a modest formal statistical background. A basic introductory statistics course is helpful in maximizing the benefit of the text. However, a researcher or practitioner with no statistical background would still find most, if not all the chapters understandable and useful.

Editorial Reviews

From the Back Cover

This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology. --This text refers to an alternate Paperback edition.

Product Details

• Paperback: 361 pages
• Publisher: Springer; 3rd edition (December 1999)
• Language: English
• ISBN-10: 0387985867
• ISBN-13: 978-0387985862
• Product Dimensions: 9.1 x 6.1 x 0.8 inches
• Shipping Weight: 1.2 pounds (View shipping rates and policies)
• Average Customer Review: 4.1 out of 5 stars  See all reviews (13 customer reviews)
• Amazon Best Sellers Rank: #173,598 in Books (See Top 100 in Books)
  • #78 in Books > Medical Books > Basic Sciences > Biostatistics

Customer Reviews

Most Helpful Customer Reviews

23 of 24 people found the following review helpful:

4.0 out of 5 stars Good intro textbook, January 3, 2003

By 

sgopal2 (Princeton NJ) - See all my reviews

This review is from: Fundamentals of Clinical Trials (Paperback)

I used this book for a class that I took last semester on clinical trial.

The authors do a good job of giving a good overview of the topics of interest, in particular: sample size calculation, use of DSMBs, trial design, choice of endpoints, randomization and issues in data analysis.

The chapters on sample size estimation and use of safety monitoring boards are quite heavy on the statistics. If you've never had an intro class in statistics, then these chapters may be way over your head.

There are a few topics that the authors didn't cover so well that I thought should have been more prominent: Choice of primary endpoints in FDA trials, general requirements of the FDA and regulatory information in general, the calculations of meta-analyses.

Overall I am quite happy with this book and will keep it on my shelf as a good reference.

22 of 24 people found the following review helpful:

4.0 out of 5 stars Generalized review, April 18, 2000

By A Customer

This review is from: Fundamentals of Clinical Trials (Paperback)

Friedman et al have done a commendable job of explaining the entire clinical trial process. The monograph is complete as to the requirements of the undertaking and adequate resource is devoted to serveral of the more problematic areas such as sample size estimation and the establishment of baseline characteristics.

16 of 17 people found the following review helpful:

4.0 out of 5 stars CONCISE MULTIDISCIPLINARY APPROACH, January 29, 2003

By 

reviewer (Zurich, Switzerland.) - See all my reviews

This review is from: Fundamentals of Clinical Trials (Paperback)

The fact that this book was designed for researchers, who are involved in experimental (clinical) trials, makes the basic knowledge of statistics essential.
Using an interactive multidisciplinary approach to investigation, this handbook embraced all aspects clinical and paraclinical survey. It is very easy-to-follow, and divulges its methodology in concise manner. "Fundamentals of Clinical Trials" is one book that will help alleviate the rigorous chores of epidemiologists. However, an advanced or versatile researcher may complain that some of the information in it are too summarized.