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Fundamentals of Clinical Trials by L. Friedman et al.

Fundamentals of Clinical Trials 

   

AUTHORS: 

  • Lawrence Friedman 
  • Curt D. Furberg
  • David L. DeMets 

PRODUCT DETAILS:

  • Paperback: 361 pages
  • Publisher: Springer; 3rd edition (December 1999)
  • Language: English
  • ISBN: 0387985867
  • Product Dimensions: 9.2 x 6.2 x 0.7 inches
  • Shipping Weight: 1.18 pounds 
EDITORIAL REVIEWS

Book Description 

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.

Card catalog description

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 text uses numerous examples of published clinical trials from a variety of medical disciplines 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. 

 

CUSTOMER REVIEWS

Good intro textbook, January 3, 2003

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.


Rating: 5.0 | Added on: 5 Nov 2006

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