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Fundamentals of Clinical Trials

AUTHOR: Lawrence M. Friedman, et al
ISBN: 0387985867

SHORT 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...

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         Editorial Review

Fundamentals of Clinical Trials
- Book Review,
by Lawrence M. Friedman, et al


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.


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         Book Review

Fundamentals of Clinical Trials
- Book Reviews,
by Lawrence M. Friedman, et al

Fundamentals of Clinical Trials

ANNOTATION

The book contains black-and-white illustrations.

FROM THE PUBLISHER

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.

FROM THE CRITICS

Bernard J. Turnock

This book presents fundamental concepts and activitiesassociated with the design and implementation of clinical researchtrials. In biomedical research, clinical trials have emerged as one ofthe most important and commonly used research designs. This bookseeks to serve both as a guide and resource for investigators involvedin clinical trials both in academic and industrial settings. It hitsthe mark on both accounts. Although the primary audience is clearlymany different categories of health professionals involved in activeresearch, this book's topics and straightforward style will also appealto students and clinicians as well. The basic concepts andapplications are presented in a manner that clearly explains therationale and key steps of the research process. As a result, thisbook facilitates understanding and appreciation of clinical trialsamong noninvestigators even while it guides and assists the efforts ofexperienced researchers. The authors all have extensive experience inthe subject matter; this volume is their third edition and has beenupdated substantially. This is a very solid addition to theliterature and a title that is likely to be read and appreciated bymany different categories of health professionals. This will be veryuseful to most health science libraries.

Doody Review Services

Reviewer: Bernard J. Turnock, MD, MPH (University of Illinois at Chicago)Description: This book presents fundamental concepts and activities associated with the design and implementation of clinical research trials. In biomedical research, clinical trials have emerged as one of the most important and commonly used research designs. Purpose: This book seeks to serve both as a guide and resource for investigators involved in clinical trials both in academic and industrial settings. It hits the mark on both accounts. Audience: Although the primary audience is clearly many different categories of health professionals involved in active research, this book's topics and straightforward style will also appeal to students and clinicians as well. Features: The basic concepts and applications are presented in a manner that clearly explains the rationale and key steps of the research process. As a result, this book facilitates understanding and appreciation of clinical trials among noninvestigators even while it guides and assists the efforts of experienced researchers. The authors all have extensive experience in the subject matter; this volume is their third edition and has been updated substantially. Assessment: This is a very solid addition to the literature and a title that is likely to be read and appreciated by many different categories of health professionals. This will be very useful to most health science libraries.

RATING

3 Stars from Doody

ACCREDITATION

Friedman, Lawrence M., MD (National Heart and Lung Institute); Furberg, Curt D., MD, PhD (Bowman Gray School of Medicine); DeMets, David L, PhD (Univ of Wisconsin)


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