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.

Fundamentals of Clinical Trials

Science & Math

Lawrence M. Friedman

Curt D. Furberg

David L. DeMets

Biological Sciences

Springer

Lawrence Friedman now offers a revised and updated edition of his comprehensive introduction to the American legal system. Rich in anecdote and historical detail, this invaluable book makes the bewildering complexity of American law understandable to us all. It explains how laws are made, from the United States Constitution to the small-town zoning board, and how law is administered by courts and agencies at every level of government. It describes the tremendous variety of law: antitrust law, family law, torts (the law of accidents), criminal justice, rules for packaging medicine and food. And it brilliantly explores important trends to reveal the way changes in law mirror, and sometimes guide, changes in society.

American Law: An Invaluable Guide to the Many Faces of the Law, and How It Affects Our Daily Lives

Rules & Procedures

W.W.Norton& Company, Inc.

Thousands of rules affect our work and play, what we buy, and how we get along with our neighbors. This book meets the need of students and general readers alike for a comprehensive introduction to the American legal system. It explains how laws are made and brilliantly explores the way changes in law mirror, and sometimes guide, changes in society.

American Law

Politics & Social Sciences

Politics & Government

W.W. Norton & Co., Inc.

"A History of American Law" has become a classic for students of law, American history and sociology across the country. In this brilliant and immensely readable book, Lawrence M. Friedman tells the whole fascinating story of American law from its beginnings in the colonies to the present day. By showing how close the life of the law is to the economic and political life of the country, he makes a complex subject understandable and engrossing. "A History of American Law" presents the achievements and failures of the American legal system in the context of America's commercial and working world, family practices and attitudes toward property, slavery, government, crime and justice. Now Professor Friedman has completely revised and enlarged his landmark work, incorporating a great deal of new material. The book contains newly expanded notes, a bibliography and a bibliographical essay.

A History of American Law

Biographies & Memoirs

Professionals & Academics

Touchstone

This volume of essays examines how the legal systems of the chief countries of Latin America and Mediterranean Europe―Argentina, Brazil, Chile, Colombia, Mexico, Puerto Rico, Venezuela, France, Italy, and Spain―changed in the last quarter of the 20th century. Through essays that provide a wealth of data on the courts and the legal profession in these countries, the book attempts to relate changes in the operation of the legal systems to changes in the political and social history of the societies in which they are embedded. The details vary, in accordance with the particular history and structure of the countries, but there are also key commonalities that run through all of the stories: democratization, globalization, and changes in the legal order that seem to be worldwide; more power to courts; a growing legal profession; and the entry of women into what was once a masculine club.

Legal Culture in the Age of Globalization: Latin America and Latin Europe

Rogelio Perez Perdomo

History

Stanford University Press

Ambivalent Legacy: A Legal History of the South

Ambivalent legacy: A legal history of the South

Peter C. Hoffer

Mark V. Tushnet

Tony A. Freyer

Harry N. Scheiber

John V. Orth

Philip J. Schwarz

Thomas D. Morris

A. G. Roeber

Kermit L.

Legal History

UNIVERSITY PRESS OF MISSISSIPPI

In this brilliant and immensely readable book, Lawrence M. Friedman tells the whole fascinating story of American law from its beginnings in the colonies to the present day. By showing how close the life of the law is to the economic and political life of the country, he makes a complex subject understandable and engrossing. A History of American Law presents the achievements and failures of the American legal system in the context of America's commercial and working world, family practices, and attitudes toward property, government, crime, and justice. Now completely revised and updated, this groundbreaking work incorporates new material regarding slavery, criminal justice, and twentieth-century law. For laymen and students alike, this remains the only comprehensive authoritative history of American law.

Law Practice

Touchstone Books

Law in America

Americas

Random House]

FUNDAMENTALS OF CLINICAL TRIALS, 3RD EDITION

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Books by Lawrence M. Friedman