Fundamentals of Clinical Trials

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Springer Science & Business Media, Jan 1, 1998 - Medical - 361 pages
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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.

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User Review  - iayork - LibraryThing

A great introduction to clinical trials: This book is a very good place to start for those who want to learn about the design and analysis of clinical trials. However there is a heavy emphasis on statistics - a basic knowledge of stats is essential. Read full review

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Introduction to Clinical Trials
What Is the Question?
General Comments
Basic Study Design
Historical ControlsData Bases
Factorial Design
The Randomization Process
Baseline Assessment
Recruitment of Study Participants
Reasons for Participation
Assessing and Reporting Adverse Effects
Assessment of HealthRelated Quality of Life
Participant Adherence
Survival Analysis

Adaptive Randomization Procedures
Dichotomous Response Variables
Sample Size Calculations for Continuous Response Variables
Sample Size for Testing Equivalency of Interventions
Monitoring Response Variables
Issues in Data Analysis
Reporting and Interpreting of Results
Multicenter Trials

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About the author (1998)

Lawrence M. Friedman was born in 1930, educated at the University of Chicago where he earned his law degree, and admitted to the Illinois bar in 1951. He received a graduate degree from the University of Chicago Law School in English legal history. After serving in the United States Army, he practiced with a law firm in Chicago and subsequently entered the teaching profession. He has taught at St. Louis University, the University of Wisconsin, and, since 1968, at Stanford University, where he is now Marion Rice Kirkwood Professor of Law. He is the author of "Contract Law in America: A Social and Economic Case Study" (1965); Government and Slum Housing: A Century of Frustration" (1968); "Law and the Behavioral Sciences" (coeditor; 1969, 2nd edition, 1977); "The Legal System: A Social Science Perspective" (1975); "Law and Society: An Introduction" (1977); "American Law and the Constitutional Order: Historical Perspectives" (coeditor, 1978); "Law and Social Change in Mediterranean Europe and Latin America" (coeditor, 1979); "The Roots of Justice: Crime and Punishment in Alameda County, California, 1870-1910" (coauthor, 1981); "American Law" (1984); "Your Time Will Come" (1985); and "Total Justice" (1985). He has contributed more than eighty articles to legal and associated journals. Professor Friedman is the past president of the Law and Society Association, and a past Fellow of the Center for Advanced Study in the Behavioral Sciences and of the Institute for Advanced Study in Berlin. He is a Fellow of the American Academy of Arts and Sciences, and the recipient of a number of awards for writing and teaching. He is married and has two daughters.

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